1. HOUSTON, Aug. 13, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system (CNS), today reported its financial results for the quarter ended June 30, 2021. Additionally, the Company provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer.

    Recent Highlights

    • Commenced patient enrollment in potentially pivotal US-based trial evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM;
    • Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and

    "Over the course of the second quarter, our team continued to execute on corporate, clinical and regulatory strategies to drive our Berubicin program toward regulatory approval as fast as possible.  We are guided by our passion to answer one of the most devastating unmet clinical needs in medicine:  unbelievably, patients suffering today from recurrent GBM still cannot turn to a single approved treatment anywhere in the world for hope.  Simply put, this must change and we are the company to change it.  With the FDA's recent award of Fast Track Designation for our lead program, we believe we are poised to finally bring a desperately-needed treatment to GBM patients potentially through this accelerated pathway. Building on a foundation of sixty years of successful anthracycline use against numerous deadly cancers as well as powerful data from our Phase 1 study of Berubicin, the only anthracycline which appears to cross the blood brain barrier in adults, we wholeheartedly believe in its potential to transform the current treatment landscape and the lives of patients," commented John Climaco, CEO of CNS Pharmaceuticals. "After a quarter of amazing progress we are well positioned for even more significant advancements of our development programs which we expect will continue to drive shareholder value in the near and long term."

    Clinical Programs Update

    Berubicin – Novel anthracycline

    CNS' lead product candidate, Berubicin, is a novel anthracycline and the first drug of its kind which appears to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company recently announced the commencement of its potentially pivotal US-based study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Patient dosing is expected to commence in the third quarter of 2021.

    The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA. Taken together we believe these important designations can be seen as a recognition of the significance of not only the unmet clinical need in GBM, but of our Berubicin program.

    For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

    Berubicin Upcoming Milestones

    Berubicin Development in the U.S.

    • Commence patient dosing in potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM in Q3 2021.

    Berubicin Development in the EU with Sublicensee Partner

    • Initiate Phase 2 multicenter clinical trial of Berubicin in adults with GBM in the second half of 2021;
    • Initiate Phase 1 pediatric study in the second half of 2021; and
    • Interim analysis of the first 18 patients in adult Phase 2 study expected in 2022.

    WP1244 Portfolio - Novel class of DNA-binding agents

    The Company continues to advance the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    WP1244 Upcoming Milestones

    • File IND in 2022.

    Summary of Financial Results for Second Quarter 2021

    The net loss for the six months ended June 30, 2021 was approximately $3.8 million compared to approximately $2.4 million for the comparable period in 2020. The change in net loss is attributable to increased personnel and activity associated with preparing for the Company's clinical trials in 2021. The Company reported research and development expenses of $4.8 million for the six months ended June 30, 2021 compared to approximately $2.1 million for the comparable period in 2020. The expenses incurred during the period were related to drug manufacturing and labor related to the preparation of the Company's Phase 2 study. General and administrative expense was approximately $2.5 million for the six months ended June 30, 2021 compared to approximately $2.3 million for the comparable period in 2020.

    As of June 30, 2021, the Company had cash and subscription receivable (fully collected on July 1, 2021) of approximately $10.5 million and working capital of approximately $12.1 million. Our current expectation is that our cash on hand (including the subscription receivable collected in full on July 1, 2021) is sufficient to fund our operations into the second quarter of 2022. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

    Additionally, the Company is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company's cash runway to extend until Q2 2022 and the timing of patient dosing to commence. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  2. VANCOUVER, British Columbia, July 12, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical-stage pharmaceutical company, is pleased to announce that CNS Pharmaceuticals Inc. ("CNS") (NASDAQ:CNSP), the company that licenses the drug candidate Berubicin to WPD for 29 countries mainly in Europe, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

    Fast Track Designation enables more frequent…

    VANCOUVER, British Columbia, July 12, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical-stage pharmaceutical company, is pleased to announce that CNS Pharmaceuticals Inc. ("CNS") (NASDAQ:CNSP), the company that licenses the drug candidate Berubicin to WPD for 29 countries mainly in Europe, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, CNS had also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

    Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need. Receiving Fast Track Designation from the U.S. FDA is a significant achievement in the advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. Many patients have almost no meaningful options and thousands lose the fight against this cancer every year. With this designation, CNS now has an accelerated pathway to approval for Berubicin and a clear opportunity to bring this potentially impactful investigational therapy more expediently.

    CNS recently announced the start of patient enrollment in its study of Berubicin for the treatment of recurrent glioblastoma multiforme. WPD would significantly benefit from advancement of Berubicin as a treatment for GBM as it has the rights to produce and sell the drug candidate in 29 countries.

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    WPD Loans

    WPD's subsidiary in Poland, WPD Pharmaceuticals sp. z.o.o. has arranged to borrow up to $150,000 USD from each of two companies, each of which are controlled by insiders. The loans bear interest at 10% per annum and mature on April 2, 2022. The loans are not convertible to shares. The insider loans are exempt from the valuation and minority shareholder approval requirements of MI 61-101 by virtue of the exemptions contain in section 5.5(a) and 5.7(a) of MI 61-101 in that the fair market value of the consideration of the notes to be issued to each of the insiders does not exceed 25% of WPD's market capitalization.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 9 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes about 29 countries in Europe and Asia, including Russia, depending on the compound.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak

    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations

    Email: investors@wpdpharmaceuticals.com 

    Tel: 604-428-7050

    Web: www.wpdpharmaceuticals.com

    Investor Relations:

    Arrowhead Business and Investment Decisions, LLC

    Thomas Renaud

    Managing Director

    42 Broadway, 17th Floor

    New York, NY 10004

    Office: +1 212 619-6889

    enquire@arrowheadbid.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future, that WPD would significantly benefit from advancement of Berubicin as a treatment for GBM. Forward-looking statements in this press release include that WPD's drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that the drug compounds may not provide the benefits expected and we may not develop them further; competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. The Company assumes no obligation to update them except as required by applicable law.

     



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  3. HOUSTON, July 1, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today provided a business update.

    Recent Highlights

    • Secured an additional $4.7 million in gross proceeds from ATM at average price of $2.32; extending the Company's cash runway to Q2 2022;
    • Granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and
    • Commenced enrollment in potentially pivotal study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.

    "In the last 60 days alone we have achieved fundamental clinical, regulatory and corporate milestones that together demonstrate CNS' operational, strategic and financial strengths.  We are continuously de-risking our Berubicin clinical program by driving development of this truly novel treatment forward as expeditiously as possible. In a mere 18 months from our IPO our laser focus on this program created a potentially pivotal study now open for enrollment with patient dosing expected to commence at any time. With the addition of our recent Fast Track Designation for GBM, we believe we are poised to execute on our milestones ahead and bring a meaningful treatment to patients who suffer from this devasting and heretofore incurable disease," commented John Climaco, CEO of CNS Pharmaceuticals. "Additionally, the $4.7 million of ATM transactions significantly bolsters our cash runway and provides funding to advance our important clinical programs for several quarters to come. We are passionate about driving Berubicin's development forward, creating value in the near- and long-term, and most importantly making a positive impact on patients lives."

    Clinical Programs Update

    Berubicin – Novel anthracycline

    CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company recently announced the commencement of its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Patient dosing is expected to commence in the third quarter of 2021.

    The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

    For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

    Additionally, the Company is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company's cash runway to extend until Q2 2022 and the timing of patient dosing to commence. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  4. HOUSTON, June 29, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

    "Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease," commented John Climaco, CEO of CNS Pharmaceuticals.

    Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

    CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals, a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

    Additionally, the Company is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

     

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  5. VANCOUVER, British Columbia, June 28, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical-stage pharmaceutical company, today provided an update on its Berubicin drug candidate clinical development program for the treatment of glioblastoma multiforme (GBM).

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.

    Phase

    VANCOUVER, British Columbia, June 28, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical-stage pharmaceutical company, today provided an update on its Berubicin drug candidate clinical development program for the treatment of glioblastoma multiforme (GBM).

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.

    Phase II Adult Glioblastoma Clinical Trial

    Berubicin's Phase I clinical trial in adults, the first time it was tested in humans, yielded promising results with 44% of the patients with glioblastoma multiforme (GBM) showing a clinical response of stable disease or better based on limited clinical data. This response rate rises to 49% in Avastin-naive patients. Importantly, Berubicin has shown evidence of improved overall survival in a patient population that currently has a dismal median survival rate of only 14.6 months from diagnosis.

    WPD expects final approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products shortly and anticipates starting a Phase II Trial in the second half of 2021. Based on the promising Phase I results, WPD plans to commence a multicenter, open-label, Phase Ib/II efficacy, and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase II dose (RP2D) identified in the Phase I study (7.5 mg/m2 Berubicin HCl), on the endpoint of Overall Response Rate in up to approximately 61 patients with GBM. The trials will include an interim analysis of the first 18 patients in the first half of 2022 for efficacy and safety as well as an extensive pharmacokinetic profile for these patients.

    More details about study could be found on ClinicalTrials.gov under number NCT04915404. After approval of the study by the Regulatory Agency clinical sites data will also be available. 

    https://www.clinicaltrials.gov/ct2/show/NCT04915404?term=wpd&draw=2&rank=3

    Phase I Pediatric Clinical Trial for Malignant Gliomas

    WPD is planning the Phase I clinical trial for malignant gliomas at two clinical sites in Poland. The study includes a multicenter, open-label, dose escalation Phase I study of intravenous Berubicin in pediatric patients. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of Berubicin and to estimate its MTD and/or RP2D when administered to pediatric patients with progressive, refractory, or recurrent HGG who have completed at least 1 standard line of therapy. This study will also make a preliminary assessment of the antitumor activity of Berubicin in this patient population in up to approximately 35 patients. This Phase I trial of Berubicin represents the first ever investigation of Berubicin in pediatric brain tumors.

    WPD has already received Ethical Committee approval for Phase I clinical trial and has submitted its request for approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Information on approval and study number in European clinical trials database will be provided within 60 days. WPD expects to commence the Phase I clinical trial in Q3/Q4 2021.

    CNS Commences Patient Enrollment in Potentially Pivotal Study of Berubicin

    CNS Pharmaceuticals (NASDAQ:CNSP) ("CNS"), the company that sublicenses the compound Berubicin to WPD for 30 countries mainly in Europe and Asia, announced open enrollment in the United States for its clinical study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.

    CNS's potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine.

    Mariusz Olejniczak, CEO of WPD commented, "I am very pleased and excited about the development we have made on Berubicin both in the United States and in Europe. Our combined WPD and CNS clinical studies are going to start to recruit patients shortly which is an exciting step in the development programs. To ensure patients are informed and updated on possible sites, we will use clinicaltrials.gov as the primary source of information. We are hopeful that this is the first step in changing the landscape of glioma treatment with products in our pipeline and trough collaboration with different companies, scientific institutions, and our license partners. I would like to take an opportunity to thank both the WPD and CNS teams and our vendors and partners including WWCT and IAG for the hard work during pandemic months."

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing, and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes for most compounds 30 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak

    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations

    Email: investors@wpdpharmaceuticals.com

    Tel: 604-428-7050

    Web: www.wpdpharmaceuticals.com

    Investor Relations:

    Arrowhead Business and Investment Decisions, LLC

    Thomas Renaud

    Managing Director

    42 Broadway, 17th Floor

    New York, NY 10004

    Office: +1 212 619-6889

    enquire@arrowheadbid.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events, or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include that WPD's drugs could be developed into novel treatments for cancer, and that we anticipate starting the Phase II Trial of Berubicin in the second half of 2021 and will include an interim analysis of the first 18 patients in the first half of 2022; and we expect to commence the Phase I pediatric clinical trial in Q3/Q4 2021. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to several risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that the technology may not provide the benefits expected and we may not engage them further; competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; our expected timing of trials may be delayed; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. The Company assumes no obligation to update them except as required by applicable law.



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  6. HOUSTON, June 17, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that as part of the annual reconstitution of the Russell stock indexes, CNS Pharmaceuticals has been selected to be added to the Russell 2000® Index effective June 25, 2021, after the close of the U.S. equity markets.

    John Climaco, CEO of CNS Pharmaceuticals, commented "We are pleased to meet this noteworthy milestone and be included in the Russell 2000® Index. As our team continues to drive our clinical program forward for the treatment of glioblastoma multiforme (GBM), we believe this inclusion well-positions us to drive market awareness. We are honored to be listed among our industry peers on what is considered to be a widely respected performance benchmark for small-cap companies. We look forward to leveraging the access and positioning this inclusion brings to unlock additional value."

    The Russell 2000® Index measures the performance of the small-cap segment of the US equity market. The Russell 2000® Index is a subset of the Russell 3000® Index representing approximately 10% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes which are part of FTSE Russell, a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide.

    For more information on the Russell Indexes, please visit the FTS Russell website at www.ftserussell.com.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

    Additionally, the Company is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

     

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  7. HOUSTON, May 19, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced open enrollment for its potentially pivotal study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.

    CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to cross the blood-brain barrier. It is in development for the treatment of a number of serious brain and CNS oncology indications. The Company intends to enroll approximately 210 subjects across 35 clinical sites in the U.S. and also plans to expand the trial into western Europe. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

    "We are delighted to begin patient enrollment and screening in this potentially pivotal trial that will provide greater insight into the potential of Berubicin to improve patient outcomes in the treatment of GBM. This represents an important milestone for our pivotal program," commented John Climaco, CEO of CNS Pharmaceuticals. "I would like to thank our clinical team for their commitment and drive to advance this important development program."

    "There remains a critical unmet need in the treatment landscape for glioblastoma. The data seen to date from Berubicin is encouraging as a potential treatment option in this devastating disease. With patient enrollment now underway and dosing to commence soon hereafter, we are another step closer to providing patients with hope and a treatment that offers improvement in progression and, importantly, overall survival," added Erin Dunbar, MD, founding physician of the Brain Tumor Center and Director of Neuro-Oncology at Piedmont Atlanta Hospital, and Principle Investigator for the study.

    The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine.

    A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

    In addition to the Company's global trial, sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of Berubicin in adult GBM in the second half of 2021 as well as a Phase 1 multicenter clinical trial of Berubicin in pediatric gliomas in 2021. The WPD trial in adults with GBM will include an interim analysis of the first 18 patients in the first half of 2022 for efficacy and safety as well as an extensive pharmacokinetic profile for these patients.

    The FDA has granted CNS Pharmaceuticals Orphan Drug Designation for Berubicin, which provides seven years of marketing exclusivity upon approval of an NDA.  CNS Pharmaceuticals intends to file for additional patents relating to Berubicin to further secure intellectual property protections.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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  8. HOUSTON, May 14, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system (CNS), today reported its financial results for the quarter ended March 31, 2021. Additionally, the Company provided a clinical update as well as a business outlook.

    "2021 is poised to be an exciting year for the Company. Throughout the first quarter, we have made continued development and regulatory progress on all fronts and are committed to driving our novel treatments forward as expeditiously as possible with the primary focus on our Berubicin program to improve patient outcomes for GBM," commented John Climaco, CEO of CNS Pharmaceuticals. "We are looking forward to the near-term initiation of patient enrollment in our potentially pivotal trial, which we believe will be a catalytic event in the evolution of CNS Pharmaceuticals as it transitions us into a late-stage clinical company. We  look forward to gaining additional insight into Berubicin's potential to unlock powerful benefits in the fight against GBM which remains as one of the most aggressive types of brain cancer. We believe there is significant potential to unlock shareholder value over the course of the next 18 months and we look forward to providing continued updates and driving momentum."

    Clinical Programs Update

    Berubicin – Novel anthracycline

    CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company expects to commence patient enrollment in its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM in the second quarter. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

    In addition to the Company's global trial, sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of Berubicin in GBM in the second half of 2021 and report an interim analysis of the first 18 patients by Q1-Q2 2022.

    Anticipated Upcoming Milestones:

    • Commence patient enrollment in potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM in Q2 2021;
    • WPD Pharmaceuticals to initiate a Phase 2 multicenter clinical trial of Berubicin in GBM in the second half of 2021;
    • The WPD trial interim analysis of the first 18 patients by Q1-Q2 2022 for efficacy as well as an extensive pharmacokinetic profile in these patients;
    • CNS Pharmaceuticals to report interim analysis of U.S. adult GMB trial when 50% of planned subjects reach 6 months in study;
    • WPD will commence a multicenter Phase 1 pediatric trial for malignant CNS tumors in 2021;
    • CNS will conduct pre-clinical evaluation of Berubicin for additional CNS cancers and cancers metastatic to the brain, including development of potential combination therapies for these indications; and
    • CNS Pharmaceuticals to expand pipeline in the evaluation of other drugs for brain cancers.

    The FDA has granted CNS Pharmaceuticals Orphan Drug Designation for Berubicin, which provides seven years of marketing exclusivity upon approval of an NDA. CNS Pharmaceuticals intends to file for additional patents relating to Berubicin to further secure intellectual property protections.

    WP1244 Portfolio - Novel class of DNA-binding agents

    The Company continues to advance the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

    Anticipated Upcoming Milestones

    • File IND in 2022

    Summary of Financial Results for First Quarter 2021

    The net loss for the three months ended March 31, 2021 was approximately $3.6 million compared to approximately $2.0 million for the comparable period in 2020. The change in net loss is attributable to increased personnel and activity associated with preparing for the Company's clinical trials in 2020. The Company reported Research and development expenses of $2.2 million for the three months ended March 31, 2021 compared to approximately $0.6 million for the comparable period in 2020. The expenses incurred during the period were related to drug manufacturing and labor related to the preparation of our Phase 2 study. General and administrative expense was approximately $1.4 million for the three months ended March 31, 2021 compared to approximately $1.3 million for the comparable period in 2020. The Company ended the quarter with $11.0 cash and cash equivalents, expected to fund operations into 2022.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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  9. HOUSTON, May 11, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will present at the Q2 Virtual Investor Summit on Tuesday, May 18th at 12:30 PM ET.  

    In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

    A live video webcast will be accessible on the Events page in the Investors section of the Company's website (www.cnspharma.com) and will be archived for 90 days following the event.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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  10. LAS VEGAS, March 16, 2021 /PRNewswire/ -- Esports Technologies, Inc., a global provider of advanced esports wagering products, today announced the appointment of Christopher Downs to its Board of Directors, effective March 5, 2021. Downs will lend his years of corporate finance experience to Esports Technologies as it accelerates its growth in esports wagering. As a board member of Esports Technologies, Downs will chair the Audit Committee and serve on both the Compensation and Nominating and Governance Committees.

    Aaron Speach, Esports Technologies Chief Executive Officer, said, "As we pursue expanding our reach in the gaming and software markets, Chris' expertise across all aspects of corporate finance and M&A will be a welcome addition to the Board."

    Downs has more than 20 years of finance experience in the banking, medical and life sciences industries. Currently, he is Chief Financial Officer for CNS Pharmaceuticals (NASDAQ:CNSP). Previously, he served in a financial leadership role at InfuSystem Holdings, Inc., as Executive Vice President and Interim Chief Financial Officer. Downs' earlier career as an investment banker included serving as a corporate finance analyst at Citigroup and several M&A boutique firms. Downs earned a Bachelor of Science in economics from the United States Military Academy at West Point, an MBA from Columbia Business School, and a Master of Science in accounting from University of Houston. He is a certified public accountant and has obtained professional designations including certified treasury professional and certified corporate financial planning and analysis professional.

    "The future of esports products and wagering is projected to grow this year and in the years ahead, and Esports Technologies is uniquely positioned in this marketplace," said Downs. "I look forward to supporting Esports Technologies' goals for growth and market penetration in the coming months and years."

    About Esports Technologies

    Esports Technologies is developing groundbreaking and engaging wagering products for esports fans and bettors around the world. Esports Technologies is a global provider of esports product, platform and marketing solutions. The company operates a licensed online gambling platform, gogawi.com, that offers real money betting on esports events and professional sports from around the world in a secure environment. The company is developing esports predictive gaming technologies that allow distribution to both customers and business partners.

    CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS

    This document contains forward-looking statements.  In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing.  We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us.  Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities.  You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms.  In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business.  These and other factors may cause our actual results to differ materially from any forward-looking statement.  Forward-looking statements are only predictions.  The forward-looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us.  We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this document and other statements made from time to time by us or our representatives might not occur.

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  11. HOUSTON, March 15, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals will present at the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC. The conference will take place virtually on March 17th  and 18th and will feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

    HOUSTON, March 15, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals will present at the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC. The conference will take place virtually on March 17th  and 18th and will feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

    In addition to the presentation, Mr. Climaco will participate in a live glioblastoma panel discussion on Wednesday, March 17th from 9:30-10:30 am ET.

    Interested parties are invited to attend the virtual conference and access exclusive content by becoming an M-Vest member and registering HERE. To learn more about the event, please visit the conference website: Emerging Growth Virtual Conference.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    About M Vest LLC

    M Vest LLC is an online investment bank and digital community built for issuers, investors, and thought leaders to share information and access investment opportunities through capital raisings of Regulation D and Regulation A Offerings.  Founded in 2017 and headquartered in New York City, M-Vest provides insights on current equity market trends, hosts presentations from public companies, and provides access to capital for emerging growth companies. M-Vest hosts live conferences and webinars featuring CEOs discussing the latest developments in their industries. M Vest LLC is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC), is a member of FINRA and SIPC, and is a sister company of Maxim Group, LLC

    About Maxim Group LLC

    Maxim Group LLC is a full-service investment banking, securities and wealth management firm headquartered in New York. The Firm provides a full array of financial services including investment banking; private wealth management; and global institutional equity, fixed-income and derivatives sales & trading, equity research and prime brokerage services. Maxim Group is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC) and the Municipal Securities Rulemaking Board (MSRB). Member of FINRA SIPC, and NASDAQ. To learn more about Maxim Group, visit maximgrp.com.

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  12. HOUSTON, March 4, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals will present at the virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021. 

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website here.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM ET for those registered for the event and will be accessible on the IR Calendar page of the Investors section of the Company's website (cnspharma.com) and will be archived for 90 days following the event.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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  13. HOUSTON, Feb. 25, 2021 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today indicated that the clinical program for Berubicin is on track to start enrolling patients in March 2021. CNS' lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to cross the blood-brain barrier. It is in development for the treatment of a number of serious brain and CNS oncology indications.

    Preparations are proceeding on schedule for the Company's study evaluating the efficacy of Berubicin in the treatment of GBM. The Company intends to enroll subjects across approximately 35 clinical sites in the U.S., with 21 sites currently confirmed and in a start-up process.  The Company also plans to expand the trial into western Europe.

    "I am very pleased with our progress and the team's execution towards the start of our program. We have made significant advancements and are now finalizing clinical site selection and preparing to begin patient screening, which we expect to commence next month," commented John Climaco, CEO of CNS Pharmaceuticals. "Berubicin's promising results demonstrated in the Phase 1 clinical trial build on sixty years of clinical experience with anthracyclines.  Berubicin is an entirely novel molecule that represents an opportunity to recognize the powerful benefits of this tried-and-true class of drugs for neuro-oncology in general and in the fight against GBM in particular. We are deeply committed to driving this program forward as expeditiously as possible with the prime focus on our mission to improve patient outcomes for GBM."

    The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. For more information about the trial, visit clinicatrials.gov (identifier NCT04762069).

    "With a dismal survival rate of only 14.6 months from diagnosis, and no currently approved second-line therapies for GBM, there remains an urgent, critical need in the treatment landscape for glioblastoma, one of the most aggressive, deadly and resistant cancers that form in the brain. GBM patients are in need of hope for a treatment that can offer improvement in progression free as well as overall survival. Given our current understanding of the promise of Berubicin, our trial design could be the best opportunity to provide the FDA with data demonstrating an effective treatment option. We look forward to beginning patient screening in the coming weeks and learning more about Berubicin in the treatment of GBM," added Dr. Sandra Silberman, CMO of CNS Pharmaceuticals.

    Anticipated Upcoming Milestones:

    • Patient screening in the Company's clinical trial for the treatment of glioblastoma will start in March 2021 with the first patient dosed shortly thereafter;
    • Our sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of Berubicin in GBM in the first half of 2021;
    • The WPD trial in adults with GBM will include an interim analysis of the first 18 patients by Q4 2021 for efficacy as well as an extensive pharmacokinetic profile in these patients;
    • WPD will commence a multicenter Phase 1 pediatric trial for malignant CNS tumors in 2021;
    • CNS will conduct pre-clinical evaluation of Berubicin for additional CNS cancers and cancers metastatic to the brain, including development of potential combination therapies for these indications; and
    • CNS will expand our pipeline in the evaluation of other drugs for brain cancers.

    The FDA has granted CNS Pharmaceuticals Orphan Drug designation for Berubicin, which provides seven years of marketing exclusivity upon approval of an NDA.  CNS Pharmaceuticals intends to file for additional patents relating to Berubicin to further secure intellectual property protections.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. During 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial (with extensive PK) in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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  14. VANCOUVER, British Columbia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD" or the "Company") today announced that it has signed an agreement with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS") to obtain Investigational Medicinal Product ("IMP") for use in the planned clinical trials of Berubicin. WPD will purchase half of the batch previously manufactured for CNS by BSP Pharmaceuticals for the WPD-201 and WPD-201P studies which are planned to begin in the first half of 2021. This IMP will be QP certified by Clinigen Clinical Supplies Management on behalf of WPD under European current Good Manufacture Practice ("cGMP") requirements.

    Berubicin is a novel anthracycline candidate for the treatment of a number…

    VANCOUVER, British Columbia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD" or the "Company") today announced that it has signed an agreement with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS") to obtain Investigational Medicinal Product ("IMP") for use in the planned clinical trials of Berubicin. WPD will purchase half of the batch previously manufactured for CNS by BSP Pharmaceuticals for the WPD-201 and WPD-201P studies which are planned to begin in the first half of 2021. This IMP will be QP certified by Clinigen Clinical Supplies Management on behalf of WPD under European current Good Manufacture Practice ("cGMP") requirements.

    Berubicin is a novel anthracycline candidate for the treatment of a number of serious oncology indications including Glioblastoma Multiforme (GBM). WPD sublicensed Berubicin from CNS in November 2019, which provided WPD with the commercial rights to Berubicin in select territories primarily in eastern Europe and Asia.

    Mariusz Olejniczak, CEO of WPD comments, "This agreement will allow us to submit a complete application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA, to initiate the studies without any delay. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office."

    Shortly after the sublicense agreement, WPD was awarded a reimbursement grant for further development of Berubicin valued at $6 million from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 trial in adult GBM in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021.

    CNS Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with their planned randomized and controlled Phase 2 trial of Berubicin in the treatment of adults with GBM who have failed first-line therapy, which is expected to commence in the first quarter of 2021. The FDA has also designated Berubicin an Orphan Drug. CNS has received Central IRB study-level approval for its GBM study.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

    About WPD Pharmaceuticals 

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. 

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things.  

    For more information, please visit wpdpharmaceuticals.com.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak

    CEO, WPD Pharmaceuticals  

    Contact:

    Investor Relations

    Email: investors@wpdpharmaceuticals.com

    Tel: 604-428-7050

    Web: www.wpdpharmaceuticals.com 

    Forward Looking Statements

    This document contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include timing for clinical trials for our drug candidates; that a large portion of our program budget will be refunded by research and other grants and that WPD's drugs could be developed into novel treatments for cancer and other diseases. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge granted patents and the patents could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; we may be unable to obtain regulatory approval for any drugs we develop; and we may otherwise be unable to carry out our business plans. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this document and the Company assumes no obligation to update them except as required by applicable law.



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  15. WPD Pharmaceuticals plans to initiate a Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021

    CNS Pharmaceuticals plans to initiate a Berubicin adult GBM trial in Q1 2021

    HOUSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming…

    WPD Pharmaceuticals plans to initiate a Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021

    CNS Pharmaceuticals plans to initiate a Berubicin adult GBM trial in Q1 2021

    HOUSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Multiforme (GBM) under the WPD-201 Clinical Trial Protocol. CNS Pharmaceuticals has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol.

    Berubicin is the Company's novel anthracycline candidate for the treatment of a number of serious oncology indications, currently in development for the treatment of GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights in select territories in Europe and Asia to Berubicin.

    Mariusz Olejniczak, CEO of WPD comments, "This is an important step for WPD from both a project and sublicense agreement point of view. After receiving the positive opinion from the Central Ethics Committee, we are planning to submit our application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office. We are planning for our sites to start recruiting patients soon after approval is received. Information about our sites will be published both on clinicaltrials.gov and in the European database. During the review process, we will start preparing submissions to Ethic Committee and Competent Authority (equivalent of FDA) in one country outside of Poland."

    "We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin," commented John Climaco, CEO of CNS Pharmaceuticals. "Importantly, we believe WPD's Ethics Committee approval of the WPD-201 Clinical Trial Protocol coupled with our recent IND approval and Central IRB Study Level approval, position us one step closer to collaboratively initiating three clinical trials for Berubicin during 2021. We look forward to continuing our trial preparations, as well as WPD's planned submissions to the Polish Competent Authority."

    Following the sublicense agreement, WPD was subsequently awarded a reimbursement grant for further development of Berubicin that was valued at $6 million upon the date of the grant from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021. Roughly 60% of the program budget is expected to be funded by the reimbursement grant.

    CNS Pharmaceuticals has received approval to proceed with their previously submitted Investigational New Drug (IND), from the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of GBM. The Company plans to initiate its Phase 2 trial evaluating the efficacy and safety of Berubicin in the treatment of adults with GBM who have failed first-line therapy in the first quarter of 2021. The Company has also received Central IRB study level approval for the U.S. portion of the adult GBM study.

    About Berubicin

    Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    About WPD Pharmaceuticals 

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. 

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things.  

    For more information, please visit wpdpharmaceuticals.com.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

     Mariusz Olejniczak

    CEO, WPD Pharmaceuticals  

    Contact:

    Investor Relations

    Email: investors@wpdpharmaceuticals.com

    Tel: 604-428-7050

    Web: www.wpdpharmaceuticals.com 

    Forward Looking Statements

    This document contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include timing for clinical trials for our drug candidates; that a large portion of our program budget will be refunded by research and other grants and that WPD's drugs could be developed into novel treatments for cancer and other diseases. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge granted patents and the patents could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; we may be unable to obtain regulatory approval for any drugs we develop; and we may otherwise be unable to carry out our business plans. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this document and the Company assumes no obligation to update them except as required by applicable law.



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  16. HOUSTON, Feb. 18, 2021 /PRNewswire/ -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Muliforme (GBM) under the WPD-201 Clinical Trial Protocol.  CNS Pharmaceuticals has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol. 

    HOUSTON, Feb. 18, 2021 /PRNewswire/ -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Muliforme (GBM) under the WPD-201 Clinical Trial Protocol.  CNS Pharmaceuticals has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol. 

    Berubicin is the Company's novel anthracycline candidate for the treatment of a number of serious oncology indications, currently in development for the treatment of GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights in select territories in Europe and Asia to Berubicin.

    Mariusz Olejniczak, CEO of WPD comments, "This is an important step for WPD from both a project and sublicense agreement point of view. After receiving the positive opinion from the Central Ethics Committee, we are planning to submit our application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office. We are planning for our sites to start recruiting patients soon after approval is received. Information about our sites will be published both on cliniclatrails.gov and in the European database. During the review process, we will start preparing submissions to Ethic Committee and Competent Authority (equivalent of FDA) in one country outside of Poland." 

    "We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin," commented John Climaco, CEO of CNS Pharmaceuticals. "Importantly, we believe WPD's Ethics Committee approval of the WPD-201 Clinical Trial Protocol coupled with our recent IND approval and Central IRB Study Level approval, position us one step closer to collaboratively initiating three clinical trials for Berubicin during 2021. We look forward to continuing our trial preparations, as well as WPD's planned submissions to the Polish Competent Authority."

    Following the sublicense agreement, WPD was subsequently awarded a reimbursement grant for further development of Berubicin that was valued at $6 million upon the date of the grant from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021. Roughly 60% of the program budget is expected to be funded by the reimbursement grant.

    CNS Pharmaceuticals has received approval to proceed with their previously submitted Investigational New Drug (IND), from the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of GBM. The Company plans to initiate its Phase 2 trial evaluating the efficacy and safety of Berubicin in the treatment of adults with GBM who have failed first-line therapy in the first quarter of 2021. The Company has also received Central IRB study level approval for the U.S. portion of the adult GBM study.

    About Berubicin

    Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer. 

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    About WPD Pharmaceuticals 

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. 

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things.  

    For more information, please visit wpdpharmaceuticals.com.

     

     

     

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    SOURCE CNS Pharmaceuticals, Inc.

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  17. HOUSTON, Jan. 7, 2021 /PRNewswire/ --  CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals, will present at the virtual H.C. Wainwright BioConnect 2021 Conference being held January 11-14, 2021.

    H.C. Wainwright BioConnect 2021 Conference:

    Date:   Monday, January 11th, 2021
    Time: 6:00 AM ET
    Link:   https://journey.ct.events/view/5dc204bc-7b68-4545-89b4-08ea81a4eee0

    The webcast will be available on demand starting Monday, January 11th, 2021 at 6:00 AM ET. Replays of the presentation will be available on the Company's…

    HOUSTON, Jan. 7, 2021 /PRNewswire/ --  CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals, will present at the virtual H.C. Wainwright BioConnect 2021 Conference being held January 11-14, 2021.

    H.C. Wainwright BioConnect 2021 Conference:

    Date:   Monday, January 11th, 2021

    Time: 6:00 AM ET

    Link:   https://journey.ct.events/view/5dc204bc-7b68-4545-89b4-08ea81a4eee0

    The webcast will be available on demand starting Monday, January 11th, 2021 at 6:00 AM ET. Replays of the presentation will be available on the Company's website for 90 days following the event.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of the first quarter of 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

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    SOURCE CNS Pharmaceuticals, Inc.

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  18. HOUSTON, Dec. 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced the pricing of an underwritten public offering of 5,000,000 shares of common stock and warrants to purchase up to 2,500,000 shares of common stock. The shares of common stock and warrants are being sold together at a combined public offering price of $2.00 per share and warrant. The warrants will have an exercise price of $2.20 per share, will be immediately exercisable and will expire five years from the date of issuance. The Company has granted the underwriter a 45-day…

    HOUSTON, Dec. 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced the pricing of an underwritten public offering of 5,000,000 shares of common stock and warrants to purchase up to 2,500,000 shares of common stock. The shares of common stock and warrants are being sold together at a combined public offering price of $2.00 per share and warrant. The warrants will have an exercise price of $2.20 per share, will be immediately exercisable and will expire five years from the date of issuance. The Company has granted the underwriter a 45-day option to purchase up to an additional 750,000 shares of common stock and/or 375,000 warrants to cover over-allotments, if any.

    The Company intends to use the net proceeds from this offering for its Phase 2 trial for Berubicin, other research and development, and for working capital. The offering is expected to close on or about December 28, 2020, subject to customary closing conditions.

    A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

    This offering is being made pursuant to an effective registration statement on Form S-1 (No. 333-251530) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective on December 22, 2020. The offering is being made only by means of a prospectus. A final prospectus relating to the proposed offering will be filed and made available on the SEC's website. A copy of the final prospectus relating to the offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: prospectus@allianceg.com. Before investing in this offering, interested parties should read the prospectus.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to close the offering. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  19. HOUSTON, Dec. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will host a conference call and live webcast on December 18th, 2020 at 8:30am ET to discuss its Investigational New Drug (IND) approval for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM), and planned Phase 2 Berubicin clinical trial.

    Details of the webcast are below:

    Date:                

    December 18th, 2020

    Time:                

    8:30 AM ET

    Link:                  

    https://edge.media-server.com/mmc/p/rg8hxqpb

    The dial-in numbers for the conference call are (800) 226-2188 for domestic callers and (602) 563-8462 for international callers. The conference ID is 6455799.

    A replay of the call will be available following its completion through December 25th, 2020. To access the replay, dial (855) 859-2056 for domestic callers and (404) 537-3406 for international callers and use the replay conference ID: 6455799.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of the first quarter of 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

     

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  20. HOUSTON, Dec. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration (FDA). The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy.  Recent correspondence between the Company and the FDA resulted in modifications…

    HOUSTON, Dec. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration (FDA). The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy.  Recent correspondence between the Company and the FDA resulted in modifications to the previously disclosed trial design, including designating overall survival (OS) as the primary endpoint of the study. OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

    "Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year," commented John Climaco, CEO of CNS Pharmaceuticals. "The Company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase 2 trial in the U.S., and 2 trials planned by our sublicensee WPD in Poland. We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. We have a tremendous opportunity ahead of us as we continue our mission to improve patient outcomes for GBM and build on the promising results demonstrated by Berubicin in its Phase 1 clinical trial."

    As previously announced, the planned trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease. Results will compare Berubicin to the current standard of care, with a 2 to 1 randomization of patients to either receive Berubicin or Lomustine. The trial's adaptive design is intended to allow an interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of the first quarter of 2021, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    Forward-Looking Statements                                                            

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company and WPD to initiate clinical trials during the first quarter of 2021, and whether the planned clinical trial will provide data to the FDA to allow an expedited pathway for development. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  21. HOUSTON, Nov. 19, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced its joint sponsorship with WPD Pharmaceuticals for the 2020 Society of NeuroOncology (SNO) Virtual Meeting held November 19-21, 2020.

    CNS and WPD's joint sponsorship is on the Supporter' level, which includes a booth in the virtual exhibit hall. Dr. Patrick Wen, Director of Center for Neuro-Oncology at Dana-Farber Cancer Institute and member of CNS Pharmaceuticals' Science Advisory Board, will be participating in a panel discussion on clinical trials during the plenary session on Friday, November 20, as well as in online poster presentations.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    About WPD Pharmaceuticals 

    WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. 

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things. 

    For more information, please visit wpdpharmaceuticals.com.

     

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  22. HOUSTON, Nov. 18, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that members of management will participate in A.G.P.'s Virtual Healthcare Symposium on Thursday, November 19th, 2020.

    The event will consist of 1-on-1 virtual investor meetings. Investors attending the conference virtually who are interested in meeting with Company management should contact their A.G.P. representative.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

     

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  23. HOUSTON, Nov. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA's acceptance of the Company's filing.

    HOUSTON, Nov. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA's acceptance of the Company's filing.

    "Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible," commented John Climaco, CEO of CNS Pharmaceuticals. "Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM."

    The planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial's adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  24. HOUSTON, Nov. 12, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced its presentation to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), will be available via webcast today at 4:30pm ET. The discussion will be moderated by Robert LeBoyer, Managing Director of Equity Research at Ladenburg Thalmann & Co., Inc.

    The Company plans to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA), which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1. The Phase 2 trial will randomize patients to Berubicin or standard of care. This upcoming trial will include interim assessments that will evaluate the comparative safety and effectiveness of these treatments with an adaptive design intended to complete a thorough investigation into Berubicin as expeditiously as possible.

    Details of the webcast are below:

    Date:                     November 12th, 2020

    Time:                     4:30 PM ET

    Link:                       https://cnspharma.com/webcast-november-2020/

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  25. HOUSTON, Nov. 9, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will be issuing a video update on November 12th, 2020 at 4:30pm ET to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer, currently considered incurable. The discussion will be moderated by Robert LeBoyer, Managing Director of Equity Research at Ladenburg Thalmann & Co., Inc.

    HOUSTON, Nov. 9, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will be issuing a video update on November 12th, 2020 at 4:30pm ET to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer, currently considered incurable. The discussion will be moderated by Robert LeBoyer, Managing Director of Equity Research at Ladenburg Thalmann & Co., Inc.

    The Company plans to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA), which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1. The Phase 2 trial will randomize patients to Berubicin or standard of care. This upcoming trial will include interim assessments that will evaluate the comparative safety and effectiveness of these treatments with an adaptive design intended to complete a thorough investigation into Berubicin as expeditiously as possible.

    Details of the webinar are below:

    Date: November 12th, 2020

    Time: 4:30 PM ET

    Link: https://cnspharma.com/webcast-november-2020/

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACTS:

    Investor Relations Contact

    James Salierno

    The Ruth Group

    646-536-7028

    jsalierno@theruthgroup.com 

    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

    kthomas@theruthgroup.com

    Corporate Communications:

    InvestorBrandNetwork (IBN)

    Los Angeles, California

    www.InvestorBrandNetwork.com

    310.299.1717 Office

    Editor@InvestorBrandNetwork.com

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  26. HOUSTON, Oct. 29, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces that its European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. With the completion of manufacturing at BSP and at its U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), the Company remains poised to file an Investigational New Drug Application…

    HOUSTON, Oct. 29, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces that its European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. With the completion of manufacturing at BSP and at its U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), the Company remains poised to file an Investigational New Drug Application ("IND") and initiate its Phase 2 U.S. clinical trial for Berubicin on its anticipated timeline.

    "We are pleased to continue to execute upon our dual-track drug product manufacturing strategy, as both our U.S. manufacturer, Pii, and European manufacturer, BSP, have now completed production of Berubicin Drug Product," commented John Climaco, CEO of CNS Pharmaceuticals. "The completion of the manufacturing process at both locations represents a key milestone for us and will further support our efforts to file an IND during the fourth quarter of this year. We are encouraged by our continued execution upon our pre-trial initiatives, and believe we remain positioned to initiate a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."

    As previously announced, the Company implemented its dual-track drug product manufacturing strategy for Berubicin. As a part of its strategy, the Company engaged a U.S. based manufacturer, Pii, and European manufacturer BSP, for the production of Berubicin Drug Product. The Company engaged two separate manufacturers in two separate continents in order to help mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Both Pii and BSP have now completed the manufacturing process for Berubicin.

    As the Company focuses on its IND filing preparations, it has made several key advancements on the clinical front to supplement its manufacturing efforts. The Company recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. Furthermore, the Company also bolstered its leadership team in advance of the trial and appointed Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. The FDA granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    For more information, please visit www.CNSPharma.com

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to file an IND in the fourth quarter of this year and to initiate its Phase 2 trial for Berubicin in the first quarter of 2021. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

     

     

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  27. HOUSTON, Oct. 20, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company's U.S. manufacturer, Pharmaceutics International, Inc. ("Pii"), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

    "Completing the manufacturing process for Berubicin in the United States is an essential step in our preparations to file an IND during the fourth quarter of this year," stated John Climaco, CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S. Phase 2 trial for Berubicin during the first quarter of 2021."

    The Company implemented a dual-track drug product manufacturing strategy to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin. Under this strategy, it engaged two separate manufacturers for Berubicin on different continents. In the United States, the Company engaged Pii, who has now completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A. ("BSP"). BSP has begun the manufacturing process, which is expected to be completed early in the fourth quarter this year.

    In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. CNS recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for its Phase 2 trial design. The Company has also added Dr. Patrick Wen, a renowned neuro-oncologist, to its Scientific Advisory Board. The FDA granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to file an IND in the fourth quarter of this year and to initiate its Phase 2 trial for Berubicin in the first quarter of 2021. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC.. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  28. HOUSTON, Oct. 12, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today highlighted a new segment of "Behind the Mystery" focused on glioblastoma from The Balancing Act airing on Lifetime TV. The segment, live this morning, follows the unique story of a glioblastoma patient and clinical insights regarding the rare and difficult-to-treat disease from Dr. Sigmund Hsu, a member of the Scientific Advisory Board of CNS Pharmaceuticals. A re-airing of the segment is planned for October 23, 2020.

    HOUSTON, Oct. 12, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today highlighted a new segment of "Behind the Mystery" focused on glioblastoma from The Balancing Act airing on Lifetime TV. The segment, live this morning, follows the unique story of a glioblastoma patient and clinical insights regarding the rare and difficult-to-treat disease from Dr. Sigmund Hsu, a member of the Scientific Advisory Board of CNS Pharmaceuticals. A re-airing of the segment is planned for October 23, 2020.

    "It is encouraging to see the Balancing Act feature bring awareness to such a devastating disease. Glioblastoma is one of the most aggressive primary brain cancers in adults, with approximately 13,000 new patients diagnosed each year in the U.S.—the highest diagnosis rate of all malignant brain tumors. At CNS, we are committed to our development efforts in glioblastoma," said John Climaco, CEO of CNS Pharmaceuticals.

    To view the segment and hear the story, visit thebalancingact.com/behind-the-mystery-glioblastoma-GBM.

    CNS Pharmaceuticals provided support for the production of this Balancing Act segment.

    About The Balancing Act

    The Balancing Act is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime®, and find all previously aired episodes on TheBalancingAct.com.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system.  Its lead drug candidate, berubicin, has been studied in a completed Phase 1 clinical trial in malignant brain tumors.  By the end of 2020, CNS expects to commence a Phase 2 clinical trial of berubicin for the treatment of glioblastoma multiforme (GBM) in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial in the fourth quarter of this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  29. HOUSTON, Oct. 9, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company's European manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has begun the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

    "Our preparations for filing an IND for Berubicin require continued execution in both our clinical and manufacturing initiatives," stated John Climaco, CEO of CNS Pharmaceuticals. "With the manufacturing of our Berubicin Drug Product in Europe, we continue to advance closer toward an IND filing for Berubicin, which we expect to submit later this quarter.  We have also made significant progress on the clinical front and recently engaged Worldwide Clinical Trials as the contract research organization, Image Analysis Group ("IAG") as the imaging partner, and Berry Consultants as a biostatistical advisor for our Phase 2 trial design. We have also added Dr. Patrick Wen, a renowned neuro-oncologist, to our Scientific Advisory Board. Our laser focus remains on initiating a U.S. Phase 2 trial for Berubicin in Q1 of 2021 and we continue to demonstrate our ability to execute our operational and clinical plans toward that goal."

    As part of the Company's plan to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin, the Company implemented a dual-track drug product manufacturing strategy. Under this dual-track strategy, it engaged two separate manufacturers for Berubicin on different continents, both U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP. As previously announced, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both Pii and BSP to prepare an injectable form of Berubicin for clinical use. BSP and Pii have now begun manufacturing of Berubicin and the Company expects to complete manufacturing at both locations early in the fourth quarter.

    The FDA recently granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to file an IND in the fourth quarter of this year and to initiate its Phase 2 trial for Berubicin in the first quarter of 2021. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC.. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  30. HOUSTON, Oct. 1, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company's GMP manufacturer partner NCK A/S, received a Certificate of Analysis (CoA) for its Active Pharma Ingredient (API), clearing it for use in the production of Berubicin.

    As previously announced, CNS signed a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. NCK A/S production of Berubicin should ensure drug availability through the end of Phase 2 clinical trials for glioblastoma.

    "We believe the execution of this critical manufacturing milestone positions the company advantageously ahead of our expected U.S. Phase 2 trial," stated John Climaco, CEO of CNS Pharmaceuticals. "Our partnerships have proven instrumental in further progressing the manufacturing process necessary to continue the clinical development of our lead candidate. We look forward to continuing the work underway and to initiating our U.S. Phase 2 trial in Q1 of 2021."

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial in the fourth quarter of this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  31. HOUSTON, Sept. 24, 2020 (GLOBE NEWSWIRE) -- via NetworkWire -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today announced it has selected Image Analysis Group ("IAG") as the image partner for its upcoming Berubicin clinical trials.

    IAG, a leading medical imaging company, will work closely with CNS during the Berubicin clinical trials to provide critical imaging services, its proprietary platform DYNAMIKA and imaging data analysis. IAG has deep expertise in partnering with biotech, and specifically oncology companies, to provide a centralized reading and analysis of patient…

    HOUSTON, Sept. 24, 2020 (GLOBE NEWSWIRE) -- via NetworkWire -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today announced it has selected Image Analysis Group ("IAG") as the image partner for its upcoming Berubicin clinical trials.

    IAG, a leading medical imaging company, will work closely with CNS during the Berubicin clinical trials to provide critical imaging services, its proprietary platform DYNAMIKA and imaging data analysis. IAG has deep expertise in partnering with biotech, and specifically oncology companies, to provide a centralized reading and analysis of patient responses in real time. IAG's scientific and clinical imaging expertise in the field of GBM will be coupled with IAG's proprietary AI and quantitative image-based assessments to allow CNS to review efficacy assessments, objective responses, and to thoroughly explore the advanced treatment manifestations. GBM therapies often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, inflammation, tumor necrosis and oedema which are often misinterpreted as tumor growth on traditional MRIs. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments.  IAG and CNS will be utilizing IAG's advanced Artificial Intelligence (AI)-driven methodologies that provide reliable early efficacy readouts.

    "Adding IAG was a key step in preparation for the recently developed clinical trials in Berubicin," commented John Climaco, CEO of CNS Pharmaceuticals. "IAG has an exemplary track record of partnering closely with companies in the biotech space to provide critical analysis of both efficacy and patient response, which we believe will be pivotal in advancing our Berubicin clinical trials. Furthermore, this was yet another key milestone achieved in our trial preparations as we continue to take all of the necessary steps to ensure a successful and timely launch of our Phase II trials. We look forward to leveraging IAG's extensive expertise, as we plan to initiate our Phase II clinical trial of Berubicin in adults early next year."

    "We are excited to partner with CNS and bring our expertise to support the optimal trial design, efficient imaging data management and review. Use of the state-of-the-art and IAG's AI driven methodologies for imaging data review will allow us to comprehensively explore Berubicin's efficacy and build significant scientific evidence, while reducing the development costs, timelines and uncertainties,"  commented Dr. Olga Kubassova, IAG's CEO and scientific founder.

    "Advanced imaging methods and computer aided image analysis is the key to successfully interpret treatment related changes in GBM and identify responders early," stated Dr. Diana Dupont-Roettger, Chief Scientific Alliance Officer at IAG. "We are excited to partner with CNS Pharmaceuticals in the development of Berubicin".

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    About IAG

    Image Analysis Group (IAG) is a unique clinical development partner to life sciences companies.  IAG broadly leverages its proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACTS:

    Investor Relations Contact

    James Salierno

    The Ruth Group

    646-536-7028

    jsalierno@theruthgroup.com 

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    The Ruth Group

    (508) 280-6592

    kthomas@theruthgroup.com

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  32. HOUSTON, Sept. 24, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today announced it has selected Image Analysis Group ("IAG") as the image partner for its upcoming Berubicin clinical trials.

    IAG, a leading medical imaging company, will work closely with CNS during the Berubicin clinical trials to provide critical imaging services, its proprietary platform DYNAMIKA and imaging data analysis. IAG has deep expertise in partnering with biotech, and specifically oncology companies, to provide a centralized reading and analysis of patient responses in real time. IAG's scientific and clinical imaging expertise in the field of GBM will be coupled with IAG's proprietary AI and quantitative image-based assessments to allow CNS to review efficacy assessments, objective responses, and to thoroughly explore the advanced treatment manifestations. GBM therapies often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, inflammation, tumor necrosis and oedema which are often misinterpreted as tumor growth on traditional MRI's. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments.  IAG and CNS will be utilizing IAG's advanced Artificial Intelligence (AI)-driven methodologies that provide reliable early efficacy readouts.

    "Adding IAG was a key step in preparation for the recently developed clinical trials in Berubicin," commented John Climaco, CEO of CNS Pharmaceuticals. "IAG has an exemplary track record of partnering closely with companies in the biotech space to provide critical analysis of both efficacy and patient response, which we believe will be pivotal in advancing our Berubicin clinical trials. Furthermore, this was yet another key milestone achieved in our trial preparations as we continue to take all of the necessary steps to ensure a successful and timely launch of our Phase II trials. We look forward to leveraging IAG's extensive expertise, as we plan to initiate our Phase II clinical trial of Berubicin in adults early next year."

    "We are excited to partner with CNS and bring our expertise to support the optimal trial design, efficient imaging data management and review. Use of the state-of-the-art and IAG's AI driven methodologies for imaging data review will allow us to comprehensively explore Berubicin's efficacy and build significant scientific evidence, while reducing the development costs, timelines and uncertainties," commented Dr. Olga Kubassova, IAG's CEO and scientific founder.

    "Advanced imaging methods and computer aided image analysis is the key to successfully interpret treatment related changes in GBM and identify responders early," stated Dr. Diana Dupont-Roettger, Chief Scientific Alliance Officer at IAG. "We are excited to partner with CNS Pharmaceuticals in the development of Berubicin."

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    About IAG

    Image Analysis Group (IAG) is a unique clinical development partner to life sciences companies.  IAG broadly leverages its proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  33. HOUSTON, Sept. 17, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today announced that CEO, John Climaco, will present virtually at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22nd, 2020 at 10:00 AM EDT.

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date:

    Tuesday, September 22nd, 2020

    Time:

    10:00 AM EDT

    Link:

    http://wsw.com/webcast/oppenheimer5/cnsp/2726100

    A replay of the presentation will be available on the Company's website for 90 days following the event. Members of management will hold 1-on-1 virtual investor meetings at the conference. Investors attending the conference virtually who are interested in meeting with Company management should contact their Oppenheimer representatives.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

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  34. HOUSTON, Sept. 11, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today announced that CEO, John Climaco, will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on Wednesday, September 16th, 2020 at 9:30 AM EDT.

    H.C. Wainwright 22nd Annual Global Investment Conference:



    Date:

    Wenesday, September 16th, 2020

    Time:

    9:30 AM EDT

    Link:

    https://wsw.com/webcast/hcw7/cnsp/1613300

    A replay of the presentation will be available on the Company's website for 90 days following the event. Members of management will hold 1-on-1 virtual investor meetings at the conference. Investors attending the conference virtually who are interested in meeting with Company management should contact their H.C Wainwright representatives.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

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  35. HOUSTON, Sept. 3, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing of Berubicin, the Company's lead drug candidate, in preparation for upcoming clinical trials.

    As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin.  By engaging two separate manufacturers on two separate continents, CNS expects to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin.

    Under this dual-track strategy, the Company has achieved several key milestones in its manufacturing efforts and is providing an update on the progress made with its U.S. manufacturer, Pii. First, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use. In preparation for production, CNS and Pii have now agreed on the manufacturing procedure and packaging components for Berubicin and selected a sterile filter manufacturer. The Company has also completed and reviewed a draft of the batch record. Importantly, the Company and Pii completed a successful laboratory simulation of the lyophilization cycle. The Company expects to begin manufacturing of Berubicin at Pii during the third quarter of this year.

    "As we prepare to initiate our upcoming Berubicin clinical trials, our execution both on the clinical and manufacturing fronts remain paramount to our success," stated John Climaco, CEO of CNS Pharmaceuticals. "We continue to be encouraged as our partner Pii has now delivered upon many of the critical steps necessary to ensure the quality and availability of Berubicin. We look forward to keeping you updated on our progress as we continue our preparations to submit an IND for Berubicin during the fourth quarter of this year."

    CNS's preparations for filing an IND entail both extensive clinical and manufacturing initiatives. In addition to the progress the Company has made in its manufacturing efforts, it has recently announced critical achievements made on the clinical front. The Company engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization (CRO) for its upcoming Berubicin clinical trials. Worldwide specializes in therapeutic areas with unmet medical needs, including CNS disorders and oncology. Worldwide will work closely with CNS to provide proactive insight and operational support for its upcoming trials. Additionally, the Company engaged Berry Consultants, a leading clinical statistical consulting group, to advise on its Phase 2 trial design for Berubicin. Berry Consultants uses Bayesian statistics to provide innovative clinical trial designs and analysis. The Company has also completed the Phase 1 Clinical Study Report, or CSR, which is now ready for publication.

    CNS was recently granted Orphan Drug Designation (ODD) for its lead product, Berubicin, for the treatment of malignant gliomas. The designation provides Berubicin with a special status that can help accelerate its development to treat malignant gliomas by providing CNS with the potential for market exclusivity upon the drug's approval. The Company plans to file an IND for Berubicin with the FDA during the fourth quarter of 2020.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  36. Houston, Texas, Sept. 03, 2020 (GLOBE NEWSWIRE) -- via NetworkWire – CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing of Berubicin, the Company's lead drug candidate, in preparation for upcoming clinical trials.

    As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin.  By engaging two separate manufacturers on two separate continents…

    Houston, Texas, Sept. 03, 2020 (GLOBE NEWSWIRE) -- via NetworkWire – CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing of Berubicin, the Company's lead drug candidate, in preparation for upcoming clinical trials.

    As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin.  By engaging two separate manufacturers on two separate continents, CNS expects to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin.

    Under this dual-track strategy, the Company has achieved several key milestones in its manufacturing efforts and is providing an update on the progress made with its U.S. manufacturer, Pii. First, CNS completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use. In preparation for production, CNS and Pii have now agreed on the manufacturing procedure and packaging components for Berubicin and selected a sterile filter manufacturer. The Company has also completed and reviewed a draft of the batch record. Importantly, the Company and Pii completed a successful laboratory simulation of the lyophilization cycle. The Company expects to begin manufacturing of Berubicin at Pii during the third quarter of this year.

    "As we prepare to initiate our upcoming Berubicin clinical trials, our execution both on the clinical and manufacturing fronts remain paramount to our success," stated John Climaco, CEO of CNS Pharmaceuticals. "We continue to be encouraged as our partner Pii has now delivered upon many of the critical steps necessary to ensure the quality and availability of Berubicin. We look forward to keeping you updated on our progress as we continue our preparations to submit an IND for Berubicin during the fourth quarter of this year."

    CNS's preparations for filing an IND entail both extensive clinical and manufacturing initiatives. In addition to the progress the Company has made in its manufacturing efforts, it has recently announced critical achievements made on the clinical front. The Company engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization (CRO) for its upcoming Berubicin clinical trials. Worldwide specializes in therapeutic areas with unmet medical needs, including CNS disorders and oncology. Worldwide will work closely with CNS to provide proactive insight and operational support for its upcoming trials. Additionally, the Company engaged Berry Consultants, a leading clinical statistical consulting group, to advise on its Phase 2 trial design for Berubicin. Berry Consultants uses Bayesian statistics to provide innovative clinical trial designs and analysis. The Company has also completed the Phase 1 Clinical Study Report, or CSR, which is now ready for publication.

    CNS was recently granted Orphan Drug Designation (ODD) for its lead product, Berubicin, for the treatment of malignant gliomas. The designation provides Berubicin with a special status that can help accelerate its development to treat malignant gliomas by providing CNS with the potential for market exclusivity upon the drug's approval. The Company plans to file an IND for Berubicin with the FDA during the fourth quarter of 2020.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACTS:

    Investor Relations Contact

    James Salierno

    The Ruth Group

    646-536-7028 / 7032

    jsalierno@theruthgroup.com 

    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

    kthomas@theruthgroup.com

    Corporate Communications:

    InvestorBrandNetwork (IBN)

    Los Angeles, California

    www.InvestorBrandNetwork.com

    310.299.1717 Office

    Editor@InvestorBrandNetwork.com

    Primary Logo

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  37. HOUSTON, Aug. 27, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announces Patrick Wen, M.D., a professor of neurology at Harvard Medical School and director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, has joined the Company's Science Advisory Board.

    "We are excited to add Dr. Wen, a neuro-oncologist with a passion for and background in investigating cures for deadly brain cancers, such as glioblastoma, to our Science Advisory Board," commented John Climaco, CEO of CNS Pharmaceuticals. "We believe Dr. Wen's extensive experience in the field of neuro-oncology will prove invaluable as we continue to prepare for our upcoming Berubicin clinical trials. The addition of Dr. Wen strongly complements our strategy to further drive the development of Berubicin as we look forward to initiating our Phase I pediatric and Phase II adult studies in Poland and our Phase II trial in the U.S."

    Dr. Wen is an accomplished neuro-oncologist with a proven track record of treating brain tumors and neurologic complications of cancer. He graduated from the Medical College of St. Bartholomew's Hospital, University of London, and completed his internal medicine training at the University of London postgraduate hospitals. Subsequently, Dr. Wen completed his neurology residency in the Harvard-Longwood Neurology Training Program. He is currently a professor of neurology at Harvard Medical School and a director of the Center for Neuro-Oncology at Dana-Farber.

    As previously announced, CNS Pharmaceuticals recently engaged USA-based Pharmaceutics International, Inc. (Pii) and Italian BSP Pharmaceuticals SpA (BSP) for the production of the Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy to mitigate COVID-19-related risks, diversify its supply chain, and provide for localized availability of Berubicin. CNS has completed synthesis of Berubicin active pharmaceutical ingredient (API) and has shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM, which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  The Company's second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology, including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in the Company's most recently filed Form 10-K, filed with the Securities and Exchange Commission ("SEC") and updated from time to time in the Company's Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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    SOURCE CNS Pharmaceuticals, Inc.

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  38. HOUSTON, Aug. 25, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the Company's plans for its lead product candidate, Berubicin, which is being studied for the treatment of glioblastoma multiforme (GBM). The company has taken significant strides in designing Phase 2 clinical trials and anticipates submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) this year and initiating clinical trials in early 2021. In preparing for the IND submission, CNS has focused on clinical trial…

    HOUSTON, Aug. 25, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the Company's plans for its lead product candidate, Berubicin, which is being studied for the treatment of glioblastoma multiforme (GBM). The company has taken significant strides in designing Phase 2 clinical trials and anticipates submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) this year and initiating clinical trials in early 2021. In preparing for the IND submission, CNS has focused on clinical trial design and implementation, as well as establishing the necessary manufacturing capabilities.

    On the clinical front, the Company has engaged Worldwide Clinical Trials (Worldwide) as the contract research organization (CRO) that will be conducting the upcoming Berubicin clinical trials. Worldwide, which specializes in therapeutic areas with unmet medical needs, including CNS disorders and oncology, will work closely with CNS to provide proactive insight and operational support. . In addition, the Company has engaged Berry Consultants, a leading clinical statistical consulting group, to advise on the Phase 2 trial design. Berry Consultants utilizes Bayesian statistics to provide innovative clinical trial designs and analysis. In preparation for submitting the IND, CNS also has completed the Clinical Study Report, or CSR, for a Phase 1 study for which the Company holds the rights.

    CNS also has made several key advances in drug manufacturing, with the goal of ensuring the quality and availability of Berubicin for the upcoming clinical trials. As part of a dual track product manufacturing strategy, CNS has engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) to produce the Berubicin finished drug product. CNS believes this strategy will help mitigate COVID-19 related risks, diversify the Company's supply chain, and provide for localized availability of Berubicin. The Company completed synthesis of Berubicin active pharmaceutical ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

    "We are extremely encouraged by the consistent progress we have made in preparation for our upcoming Berubicin clinical trials," commented John Climaco, CEO of CNS Pharmaceuticals. "The CNS team is deeply experienced in the design and execution of clinical trials and as a result of our preparations, we have continued to deliver upon our strategic timeline and remain on track to execute our upcoming milestones. We believe our efforts optimally position us to submit an IND for Berubicin in the fourth quarter of this year."  Unless FDA acts to the contrary, an IND goes into effect 30 calendar days after submission to the agency, which allows the sponsor to initiate the clinical trial presented in the IND. 

    FDA recently granted the Company Orphan Drug Designation (ODD) for Berubicin for the treatment of malignant gliomas, which include GBM. The designation provides Berubicin with certain benefits during the product's development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug's approval for that use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 GBM trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  The Company's second drug candidate, WP1244, is a novel DNA binding agent that in preclinical studies has shown promising potency in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to file an IND for Berubicin during the fourth quarter of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  39. HOUSTON, Aug. 20, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it has engaged Worldwide Clinical Trials ("Worldwide") as the contract research organization ("CRO") for its upcoming Berubicin clinical trials.

    Worldwide is a a full-service, midsize, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. Worldwide specializes in therapeutic areas where there remain unmet medical needs, including CNS disorders and oncology. Worldwide provides proactive insight and operational support and has successfully managed clinical trials across more than 60 countries.

    "Designing and operating trials in areas of high unmet medical need, such as glioblastoma, is a challenging and complex task for any company. We are excited to bring on a high caliber partner such as Worldwide, which has extensive expertise in CNS and oncology, as our CRO for the upcoming Berubicin clinical trials," commented John Climaco, CEO of CNS Pharmaceuticals. "Engaging Worldwide is one of the key pieces of our preparations. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Berubicin's clinical development. We believe that with Worldwide's deep clinical CNS and oncology experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase II Berubicin trials in adults in the US and Poland as well as our Phase I pediatric trial."

    "The relationship between CNS Pharmaceuticals and Worldwide exemplifies state-of-the-art strategic program development – innovative program design coupled to exceptional clinical and operational acumen for a compound that offers considerable promise to both adults as well as children with such devastating illnesses," commented Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer at Worldwide. "Speaking on behalf of our organization, it is a privilege to express our personal and professional commitment to its success."

    The Company's decision to engage Worldwide as its CRO for the upcoming Berubicin clinical trials is the latest milestone in a series of recent preparation achievements. The Company has been active in implementing its strategic plan and engaged US-based Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP) for the production of Berubicin drug product. The decision to add both Pii and BSP as manufacturers of Berubicin was part of the Company's strategy to implement a dual-track drug product manufacturing strategy. The Company believes this dual-track strategy will help mitigate COVID-19 related risks, diversify its supply chain, and provide for localized availability of Berubicin. Furthermore, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and shipped API to both manufacturers to prepare an injectable form of Berubicin for clinical use.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    About Worldwide Clinical Trials

    Worldwide Clinical Trials employs more than 1,700 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs—in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.

    With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We're never satisfied with the status quo. We're the Cure for the Common CRO.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  40. HOUSTON, Aug. 11, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced that CEO, John M. Climaco, will be issuing a shareholder webinar on August 13th, 2020 at 4:30pm ET to discuss business developments and the progress of the Company's lead candidate Berubicin, novel DNA-binding agent WP1244 and development agreement with WPD Pharmaceuticals for WP1122.

    Details of the webinar are below:



    Date:         

    August 13th, 2020



    Time:          

    4:30-5:00pm ET



    Link:            

    https://cnspharma.com/webcast-august-2020/

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements

    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

     

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  41. HOUSTON, July 22, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today recognizes Glioblastoma (GBM) Awareness Day.

    GBM is a highly aggressive and virtually incurable form of brain cancer. Every year, roughly 10,000 individuals in the United States are expected to succumb to glioblastoma.  Accounting for more than 60% of all brain tumors in adults, it is estimated that more than 13,000 Americans will be diagnosed with GBM in 2020. For the past several decades, the survival outcomes and mortality rates for patients with GBM have improved only slightly. Patients diagnosed with GBM currently have a median survival time of 14-16 months, and a five-year survival rate of just 6.8%.

    CNS Pharmaceuticals is continuing to drive the development of Berubicin, a novel therapy for the treatment of glioblastoma. Berubicin is an anthracycline, a class of anticancer agents among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Berubicin has demonstrated the potential to be one of the first anthracyclines to cross over the blood brain barrier and kill tumor cells in humans. In a Phase 1 human clinical trial under a prior developer, 44% of patients treated with Berubicin experienced a statistically significant improvement in progression-free survival and one patient experienced a durable complete response.

    As part of the Company's efforts to initiate a Phase II trial in GBM by the end of the year, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP) to produce Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy to mitigate COVID-19 related risks, diversify its supply chain, and reduce the risk that inefficiencies could impact the Company's clinical timeline. Through contracting both a European and United States manufacturer, the Company also provided for localized availability of Berubicin for the upcoming Phase I Pediatric and Phase II adult studies in Poland, and the U.S. Phase II trial. CNS has completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has shipped API to both Pii and BSP to prepare an injectable form of Berubicin ready for clinical use. CNS believes these are pivotal steps in allowing the Company to initiate clinical studies in GBM patients.

    "Among brain tumors, GBM remains an unmet need for patients, with bleak survival outcomes and mortality rates," commented John Climaco, CEO of CNS Pharmaceuticals. "We would like to take the time today to recognize GBM Awareness Day, and draw attention to providing solutions to this very aggressive form of brain tumor which claims numerous lives every single year. Treating GBM and driving the clinical development of Berubicin remains a key priority for CNS Pharmaceuticals and we are extremely pleased to be making tremendous progress towards our upcoming trials to help these patients. We look forward to further investigating Berubicin's potential to treat this deadly cancer in our upcoming Phase I Pediatric and Phase II adult studies in Poland and initiating our U.S. Phase II trial."

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  42. HOUSTON, July 15, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the manufacturing strategy for Berubicin drug product, its lead drug candidate for the treatment of glioma brain tumors.

    In June, CNS Pharmaceuticals successfully engaged USA-based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP), respectively, for the production of Berubicin drug product. The Company decided to implement a dual-track drug product manufacturing strategy in order to mitigate both COVID-19 related risks, as well as to diversify its supply chain and reduce the risk that inefficiencies could impact the Company's clinical timeline. The Company's decision to have both a European and United States manufacturer also provides for localized availability of Berubicin for the upcoming Phase I Pediatric and Phase II adult studies in Poland and the U.S. Phase II trial. As previously announced, CNS completed synthesis of Berubicin Active Pharmaceutical Ingredient (API) and has now shipped API to two companies, Pii and BSP, that will prepare an injectable form of Berubicin ready for clinical use. This is an important step to allow CNS to initiate clinical studies in GBM patients.

    "Our decision to contract both Pii and BSP represents a key part of our overall strategy to get Berubicin back into clinical trials as soon as possible," stated John Climaco, CEO of CNS Pharmaceuticals. "Importantly, we felt it prudent to diversify our production strategy given the difficulty of predicting COVID-19 related risks and supply chain constraints. With our laser focus on initiating our Phase 2 trial by the end of the 2020, we believe the decision to engage both manufacturers positions us optimally to continue to execute on our timeline and reduce the risks of delays."

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial by the end of 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  43. HOUSTON, July 8, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announced today it has completed shipping its Active Pharma Ingredient (API) to both Maryland based Pharmaceutics International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A., (BSP), respectively, for the production of Berubicin.

    "As we continue to prepare for our upcoming Berubicin Phase 2 trial, ensuring proper manufacturing and delivery of drug product is a key priority," stated John Climaco, CEO of CNS Pharmaceuticals. "We are excited to execute on yet another key milestone, and deliver Berubicin's API to our trusted partners PII and BSP. We will continue our focus on executing upon all of the necessary steps as we look to pave the way for our upcoming U.S. Phase 2 trial, expected to initiate during the fourth quarter of this year."

    CNS previously entered into manufacturing contracts with Pii and BSP for the production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. The decision to implement a binary manufacturing strategy mitigates COVID-19 related manufacturing risks for the upcoming Phase I study in Poland and the upcoming U.S. Phase 2 trial. The first API shipments to PII and BSP commenced in June.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial in the fourth quarter of this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  44. HOUSTON, June 30, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it has engaged Berry Consultants, a leading clinical statistical consulting group, to advise the Company ahead of its Phase 2 trial regarding its lead drug candidate Berubicin.

    "We are extremely excited to have Berry Consultants, a renowned clinical statistical consulting company, advise on our Phase 2 trial design," commented John Climaco, Chief Executive Officer of CNS. "We believe the company's unparalleled expertise and innovative approach to clinical trial design will prove invaluable in the construction of our Phase 2 trial for Berubicin. With the support of Dr. Berry and his team's deep experience and advice, we look forward to further driving the development of our lead candidate, Berubicin, and initiating our Phase 2 trial in the fourth quarter of this year."

    Berry Consultants is a statistical consulting company specializing in the Bayesian approach to medical statistics, an approach that is radically changing the way research is done throughout the medical industry in both device and drug development.  Berry Consultants employs world renowned experts in Bayesian statistics and strives to set the standard for innovative clinical trial design and analysis in the statistical and medical communities. Founder Dr. Don Berry is a professor in the Department of Biostatistics of The University of Texas MD Anderson Cancer Center and has designed and supervised the conduct of hundreds of clinical trials, including in glioblastoma, GBM-AGILE, and pancreatic cancer. As a result of his prolific experience in clinical design, he is a Thomson Reuters Highly Cited Researcher, a distinction he received for ranking in top 1% of most cited researchers in Clinical Medicine. Dr. Berry received his Ph.D. in statistics from Yale University, and has served on the faculty at the University of Minnesota and Duke University.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements

    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiate its Phase 2 trial in the fourth quarter of this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  45. HOUSTON, June 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that John Climaco, CEO of CNS Pharmaceuticals, will present at the Life Sciences Investor Forum being held virtually on June 25th, 2020 at 12:30pm ET.

    Details of the presentation are below:

    Event:

    Life Sciences Investor Forum

    Date:

    June 25th, 2020

    Time:

    12:30 – 1:00 PM ET

    Link:

    https://www.lifesciencesinvestorforum.com/events/event-details/agenda

    This will be an interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join on the day of the conference, an archived webcast will also be made available after the event.

    It is recommended that investors pre-register for the event using the following link: https://www.lifesciencesinvestorforum.com/login-registration.

    Learn more about the event at www.lifesciencesinvestorforum.com.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements

    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, the Company's ability to initiate a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  46. HOUSTON, June 11,  2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead product Berubicin for the treatment of malignant gliomas.

    "We are pleased to receive Orphan Drug Designation for Berubicin, our lead candidate. The designation provides Berubicin with a special status that can accelerate its development to treat malignant gliomas, and provides CNS with the potential for market exclusivity upon the drug's approval," stated John Climaco, CEO of CNS Pharmaceuticals. "In the Phase 1 trial of Berubicin to treat glioblastoma, one of the world's most aggressive cancers, under a prior developer, 44% of the patients demonstrated a significant improvement in progression free survival, and one patient experienced a complete response. We look forward to continuing to execute on our strategic plan and initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year."

    Chief Medical Officer of CNS, Dr. Sandra Silberman, stated, "We are excited to continue to drive the development of Berubicin and work towards addressing a critical unmet medical need. Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe Berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas."

    The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata. 

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements

    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, the Company's ability to initiate a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  47. HOUSTON, June 9, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced highlights from its 2020 Annual Meeting of Shareholders.

    On June 8th 2020, CNS held its Annual Meeting of Shareholders. A total of 13,254,656 shares voted, representing over 80% of the total shares outstanding. All five board members up for re-election, including John Climaco, George Gumulka, Jeffry R. Keyes, Andrzej Andraczke, and Carl Evans, were re-elected with over 99.6% of votes in favor and no votes against. The Company's two additional proposals were passed with limited opposition, receiving over 98% votes in favor.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements

    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  48. HOUSTON, May 28, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces it has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center relating to potential cancer treatment technologies, including WP1244, a novel DNA binding agent that is up to 500-times more potent than the clinically used chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. 

    Waldemar Priebe, M.D., Professor of Medicinal Chemistry in the Department of Experimental Therapeutics at MD Anderson, will serve as Principal…

    HOUSTON, May 28, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces it has entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center relating to potential cancer treatment technologies, including WP1244, a novel DNA binding agent that is up to 500-times more potent than the clinically used chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. 

    Waldemar Priebe, M.D., Professor of Medicinal Chemistry in the Department of Experimental Therapeutics at MD Anderson, will serve as Principal Investigator for the research project.  Dr. Priebe is the founder of CNS. This relationship is managed in accordance with MD Anderson's conflict of interest policies.

    "We are delighted to be collaborating with researchers at MD Anderson to accelerate development of a novel class of antitumor agents represented by the lead compound WP1244. Most importantly, it is able to effectively cross the blood-brain barrier, thus able to kill cancer cells located in the brain. WP1244 has shown potency in killing tumor cells and in vivo activity in relevant orthotopic brain tumor model and demonstration of agent's therapeutic potential and its potentially novel mechanism of action are highly promising," said John M. Climaco, Chief Executive Officer of CNS. "Dr. Priebe and his colleagues will be performing research focused on studying in detail WP1244 and this class of agents as well as on developing other unique novel technologies allowing to target CNS malignancies. We are excited by the possibility to advance new technologies such as WP1244 toward human clinical studies in patients with primary or metastatic brain cancers."

    About WP1244
    WP1244 is an anticancer drug candidate representing novel class of DNA binding agents with unique biological properties. Currently in preclinical studies, WP1244 is exceedingly potent with in vitro IC50 values in the subnanomolar range. A previous animal study confirmed the presence of WP1244 in murine brain tissue, thereby demonstrating its ability to cross the blood-brain barrier. WP1244 was designed, synthesized and patented at The University of Texas MD Anderson Cancer Center utilizing a "modular" drug design strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements
    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of WP1244. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  49. HOUSTON, May 27, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that it has received notification from Nasdaq that trading in the Company's common stock will resume on Thursday, May 28, 2020.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  50. NEW YORK, May 27, 2020 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market® (NASDAQ:NDAQ) announced that trading in CNS Pharmaceuticals Inc. (NASDAQ:CNSP) is scheduled to resume on Thursday, May 28, 2020, at 7:00 a.m. Eastern Time. Trading in the company's stock was halted on May 4, 2020 at 9:25:06 Eastern Time.

    For news and additional information about the company, please contact the company directly or check under the company's symbol using InfoQuotesSM on the Nasdaq® Web site.

    For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at http://www.nasdaq.com.

    Nasdaq Media Contact:
    Bianca Fata
    Bianca.Fata@nasdaq.com

    NDAQO

     

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    NEW YORK, May 27, 2020 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market® (NASDAQ:NDAQ) announced that trading in CNS Pharmaceuticals Inc. (NASDAQ:CNSP) is scheduled to resume on Thursday, May 28, 2020, at 7:00 a.m. Eastern Time. Trading in the company's stock was halted on May 4, 2020 at 9:25:06 Eastern Time.

    For news and additional information about the company, please contact the company directly or check under the company's symbol using InfoQuotesSM on the Nasdaq® Web site.

    For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at http://www.nasdaq.com.

    Nasdaq Media Contact:
    Bianca Fata
    Bianca.Fata@nasdaq.com

    NDAQO

     

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  51. HOUSTON, May 27, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the development of WP1122. As previously announced, CNS entered into an agreement with WPD Pharmaceuticals for the development of several preclinical drug candidates for antiviral indications, including WP1122, in certain territories. WPD Pharmaceuticals previously licensed rights to WP1122, from Moleculin Biotech, Inc. (Moleculin) for certain territories.

    Today, Moleculin announced that on May 1, 2020 it submitted a request to the US Food and Drug Administration ("FDA") for a Pre-IND Meeting to seek guidance on requirements for submitting an Investigational New Drug ("IND") application to study its drug candidate, WP1122, in a clinical trial for patients with COVID-19, and that on May 6, 2020, the FDA granted Moleculin's meeting request, and indicated that its goal for providing written responses is June 30, 2020, but that it plans to act early on this meeting request, provided there are no significant deficiencies in the Pre-IND package or unexpected shifts in its work priorities. Moleculin further stated that it may be able to submit its IND application in the second half of this year. More specific timing will depend upon the guidance Moleculin receives from its Pre-IND Meeting with the FDA.

    Additionally, Moleculin announced that it engaged ImQuest BioSciences ("ImQuest") and the Illinois Institute of Technology Research Institute ("IITRI"). IITRI is initially focused on preclinical toxicology testing to help determine whether WP1122 can be considered safe for testing in humans. ImQuest conducted two rounds of preclinical assessment of the potential for WP1122 to address COVID-19. The first round was to demonstrate whether or not the improved pharmacology of WP1122 gave it a greater therapeutic window than 2-DG. The second round was to demonstrate the ability of WP1122 to inhibit coronavirus production in mammalian cell culture. The testing done by ImQuest was performed on a surrogate of SARS-CoV-2 called Human coronavirus strain 229E ("HCoV-229E").

    Although these in vitro results should not be considered conclusive or indicative of what will happen in vivo, the initial results, received by Moleculin on May 4, 2020, showed that both 2-DG and WP1122 have an antiviral effect on HCoV-229E. WP1122 displayed a greater therapeutic index than 2-DG, while the virus yield reduction assay demonstrated a 5 to 10-fold inhibition of coronavirus production by WP1122 and 2-DG when compared to untreated virus control. Moleculin is having ImQuest repeat its tests to provide additional confidence in its findings. In addition to having ImQuest repeat their tests, Moleculin announced that it is arranging for additional in vitro testing to include additional human cell lines and the use of a validated SARS-CoV-2 assay, as well as testing against other pathogenic viruses. The Company cautions readers that these results are initial and are not conclusive. 

    Under the terms of the development agreement with WPD Pharmaceuticals, CNS agreed to fund a portion of the development costs of WP1122 and other drug candidates for antiviral indications in exchange for certain economic rights. CNS made an upfront cash payment of $225,000 and committed to a milestone payment of $775,000 to WPD Pharmaceuticals upon the successful completion of a Phase 2 study. In return, CNS is entitled to receive 50% of the net sales, less WPD's license costs, of resulting commercial products in WPD's licensed territories, other than Poland. Those territories include 29 countries in Europe and Asia, including Russia.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, whether the results of Moleculin's subsequent testing will statistically support the initial ImQuest results, and Moleculin's ability to file an IND in the second half of 2020, if at all. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  52. NEW YORK, May 18, 2020 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market® (NASDAQ:NDAQ) announced that the trading halt status in CNS Pharmaceuticals Inc. (NASDAQ:CNSP) was changed to "additional information requested" from the company. Trading in the company's stock had been halted on May 4, 2020 at 9:25:06 Eastern Time  at a last sale price of $2.76.

    Trading will remain halted until CNS Pharmaceuticals Inc. has fully satisfied Nasdaq's request for additional information.

    For news and additional information about the company, please contact the company directly or check under the company's symbol using InfoQuotesSM on the Nasdaq® Web site.

    For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at http://www.nasdaq.com.

    NDAQO

    NEW YORK, May 18, 2020 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market® (NASDAQ:NDAQ) announced that the trading halt status in CNS Pharmaceuticals Inc. (NASDAQ:CNSP) was changed to "additional information requested" from the company. Trading in the company's stock had been halted on May 4, 2020 at 9:25:06 Eastern Time  at a last sale price of $2.76.

    Trading will remain halted until CNS Pharmaceuticals Inc. has fully satisfied Nasdaq's request for additional information.

    For news and additional information about the company, please contact the company directly or check under the company's symbol using InfoQuotesSM on the Nasdaq® Web site.

    For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at http://www.nasdaq.com.

    NDAQO

    Nasdaq Media Contact:
    Bianca Fata
    Bianca.Fata@nasdaq.com

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  53. HOUSTON, May 18, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that pending the receipt of additional information from the Company, Nasdaq has halted the trading in the Company's common stock. The Company is actively working with the staff of Nasdaq to provide it with all requested information, and hopes to begin trading as soon as possible.

    The May 1st, 2020 temporary suspension by the Securities and Exchange Commission in the trading of CNS securities expired at 11:59 p.m. ET on May 15th, 2020. 

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, when the Nasdaq trading halt will be lifted. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  54. HOUSTON, May 11, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc., (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that since the May 1st, 2020 temporary suspension by the Securities and Exchange Commission (SEC) in the trading of CNS Pharmaceuticals, Inc. (CNSP) securities, additional information has come to the Company's attention regarding information disseminated by third parties.

    The Company has learned that certain third parties made and distributed statements, claims and information during the period between March 20th, 2020 to May 5th, 2020 about the potential efficacy and clinical development of WP1122, a drug candidate in which the Company has an economic interest (collectively the "Third Party Statements").The Company neither solicited, had advance knowledge of, nor played any role in the preparation or distribution of such Third Party Statements. The Company first learned of the Third Party Statements after May 1st.

    The Company strongly encourages all investors, potential investors or any persons with interest in the Company or its research to look to the Company's press releases and securities filings for definitive information regarding the Company's operations.The SEC's suspension of trading CNS stock is scheduled to terminate at 11:59 p.m. ET on May 15th, 2020.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, whether the trading suspension will terminate on May 15, 2020. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    Investor Relations Contact
    James Salierno / Kait Brosco
    The Ruth Group
    646-536-7028 / 7032
    jsalierno@theruthgroup.com 
    kbrosco@theruthgroup.com

    Media Contact
    Kirsten Thomas
    The Ruth Group
    (508) 280-6592
    kthomas@theruthgroup.com 

     

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  55. HOUSTON, May 4, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced the securities of the Company have been placed in a temporary trading halt following notification by the US Securities and Exchange Commission.

    On May 1, 2020, the US Securities and Exchange Commission published Release No. 88802, under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), announced a temporary suspension of trading in the Company's securities due to statements made by CNSP and others in press releases to investors issued between March 23, 2020 and April 13, 2020 concerning the Company's business, including the status of development of a drug candidate labeled WP1122, the status of testing WP1122's impact on COVID-19, and the ability to expedite regulatory approval of any such treatment. The trading halt was initiated at 9:30 a.m. EDT on May 4, 2020 and will be terminated at 11:59 p.m. EDT on May 15, 2020. The Company is presently in discussions with the US Securities and Exchange Commission regarding its action and will provide further guidance as appropriate.

    "CNS Pharmaceuticals is working with the SEC Commission to demonstrate the accuracy and adequacy of information the Company has released into the marketplace regarding the Company and its product candidates," said Company CEO John Climaco. "While we take this somewhat unusual action by the SEC seriously, we have always taken, and will always take equally seriously, our duty to provide investors with accurate, complete and timely disclosures and announcements."

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  56. HOUSTON, April 30, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system in collaboration with WPD Pharmaceuticals Inc. (CSE:WBIO) (8SV1.F) ("WPD") a clinical stage pharmaceutical company, today announced it has identified several leading medical institutions in Poland to conduct its Berubicin Phase 2 clinical trial in adults with glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer.

    The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of CNS Pharmaceuticals. The Company expects to initiate both its Phase 2 US and Polish trial of Berubicin in adults with GBM during the second half of 2020.

    As previously announced, CNS entered into a sublicense agreement with WPD providing WPD commercial rights in selected territories in Europe and Asia to Berubicin. WPD was subsequently awarded a reimbursement grant that was valued at $6 million upon the date of the grant from the EU/Polish National Center for the research and development of Berubicin. Proceeds from this grant will be used to support the Company's upcoming Phase 2 clinical trial of Berubicin in adults with GBM in Poland.

    Mariusz Olejniczak, CEO of WPD Pharmaceuticals commented, "We are honored to have the leading cancer research and treatment facilities in Poland interested in further development of Berubicin." He continued, "We are doing our best to assure that Phase 2 trial in adults and Phase I pediatric trial will start during the second half of 2020. The continued enthusiasm remains a key driver in our development pipeline."

    "The grant awarded to WPD by the National Centre for Research and Development is a testament to the unmet medical need facing patients with GBM," commented John M. Climaco, CEO of CNS Pharmaceuticals. "We look forward to initiating this investigation of a unique topoisomerase II inhibitor that appears to cross the blood-brain barrier, with the goal of bringing a much-needed new treatment to GBM patients around the world."

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.

    About CNS Pharmaceuticals, Inc.

    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements

    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive orphan drug designation for Berubicin and to commence Phase II trials of Berubicin this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  57. VANCOUVER, British Columbia, April 30, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO) (FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, is pleased to announce that in collaboration with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), a biopharmaceutical company, it has identified several leading medical institutions in Poland to conduct its Berubicin Phase 2 clinical trial in adults with glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer.

    The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of both WPD and CNS. The Company expects to initiate both its Phase 2 US and…

    VANCOUVER, British Columbia, April 30, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO) (FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, is pleased to announce that in collaboration with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), a biopharmaceutical company, it has identified several leading medical institutions in Poland to conduct its Berubicin Phase 2 clinical trial in adults with glioblastoma multiforme ("GBM"), an aggressive and incurable form of brain cancer.

    The US Phase 2 trial Sponsor will be CNS and the Polish Phase 2 trial Sponsor will be WPD, a Polish corporation founded by Professor Waldemar Priebe, founder of both WPD and CNS. The Company expects to initiate both its Phase 2 US and Polish trial of Berubicin in adults with GBM during the second half of 2020.

    As previously announced, WPD entered into a sublicense agreement with CNS, which gives WPD commercial rights in selected territories in Europe and Asia to Berubicin. WPD was subsequently awarded a reimbursement grant that was valued at $6 million as at the date the grant was announced from the EU/Polish National Center for the research and development of Berubicin. Proceeds from this grant will be used to support the Company's upcoming Phase 2 clinical trial of Berubicin in adults with GBM in Poland.

    Mariusz Olejniczak, CEO of WPD Pharmaceuticals commented, "We are honored to have the leading cancer research and treatment facilities in Poland interested in further development of Berubicin." He continued, "We are doing our best to assure that Phase 2 trial in adults and Phase I pediatric trial will start during the second half of 2020. The continued enthusiasm remains a key driver in our development pipeline."

    "The grant awarded to WPD by the National Centre for Research and Development is a testament to the unmet medical need facing patients with GBM," commented John M. Climaco, CEO of CNS Pharmaceuticals. "We look forward to initiating this investigation of a unique topoisomerase II inhibitor that appears to cross the blood-brain barrier, with the goal of bringing a much-needed new treatment to GBM patients around the world."

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WPD Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company can develop effective drugs, that some of its drug candidates may be fast tracked with orphan drug designation; and that we will receive partial reimbursement for certain of its research. Factors which may prevent the forward looking statement from being realized include that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that results obtained in limited trials may not be able to be duplicated in the general population; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that ODD status is rejected by the FDA; that the EU changes the terms of the grants; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

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  58. VANCOUVER, British Columbia, April 24, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company is pleased to announced that its license partner, CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS") filed an application with the U.S. Food and Drug Administration ("FDA") under the Orphan Drug Act to receive Orphan Drug Designation ("ODD") for its brain cancer drug candidate, Berubicin. WPD was previously awarded a reimbursement grant of approximately $6 million by the Polish National Center for Research and Development for a Phase 2 study of Berubicin, in Poland.

    Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of…

    VANCOUVER, British Columbia, April 24, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company is pleased to announced that its license partner, CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS") filed an application with the U.S. Food and Drug Administration ("FDA") under the Orphan Drug Act to receive Orphan Drug Designation ("ODD") for its brain cancer drug candidate, Berubicin. WPD was previously awarded a reimbursement grant of approximately $6 million by the Polish National Center for Research and Development for a Phase 2 study of Berubicin, in Poland.

    Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer's Phase 1 trial of Berubicin, 44% of the patients received a significant clinical benefit from their treatment. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin and remains alive today, 14 years after treatment. 

    Mariusz Olejniczak, CEO of WPD commented, "In collaboration with our License partner, CNS, we are excited to announce this FDA submission for Berubicin, as it would if granted, award special status and accelerate the development of the drug candidate to treat glioblastoma, one of the world's most aggressive forms of cancer. We look forward to providing additional information on the initiation of a Phase II trial utilizing the $6 million grant to evaluate the effect of Berubicin on patients with glioblastoma later this year."

    The Orphan Drug Act ("ODA") provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). 

    The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan Drug Designation would qualify Berubicin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. There is no assurance that ODD status will be approved.

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc., a US$5.25Bn pharmaceuticals company.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WPD Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company can develop effective drugs, that some of its drug candidates may be fast tracked with orphan drug designation; and that we will receive partial reimbursement for certain of its research. Factors which may prevent the forward looking statement from being realized include that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that results obtained in limited trials may not be able to be duplicated in the general population; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that ODD status is rejected by the FDA; that the EU changes the terms of the grants; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

     

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  59. HOUSTON, April 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.

    Under a prior developer, Berubicin, then known as RTA 744, was granted ODD by the FDA for the treatment of malignant gliomas. In the prior developer's Phase 1 trial of Berubicin, 44% of the patients demonstrated a significant improvement in progression free survival. Additionally, one patient in this study experienced a complete response to his treatment with Berubicin.

    "We are excited to announce the Orphan Drug application submission for Berubicin, as it would grant special status and accelerate the development of Berubicin to treat glioblastoma, one of the world's most aggressive forms of cancer," stated John Climaco, CEO of CNS Pharmaceuticals. "We are pleased to continue to execute upon our strategic initiatives and submit our application within the anticipated timeline outlined within our previous filings. We feel cautiously optimistic about the application, given the past Orphan Drug Designation of the molecule and positive Phase 1 results. We look forward to initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year."

    The Orphan Drug Act ("ODA") provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status").

    The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan Drug Designation would qualify Berubicin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata. 

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive orphan drug designation for Berubicin and to commence Phase II trials of Berubicin this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  60. HOUSTON, April 22, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that CEO, John M. Climaco, will be issuing a shareholder webinar on April 22nd, 2020 at 4:30pm ET to discuss the Company's novel DNA-binding agent, WP1244, and to provide an update on both the development of WP1122 through its strong relationship with WPD Pharmaceuticals in Poland, and a glioblastoma survivor treated with Berubicin.

    Details of the webinar are below:

    Date:

    April 22nd, 2020

    Time:

    4:30-5:00pm ET

    Link:

    https://cnspharma.com/webinar-april-2020/

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  61. VANCOUVER, British Columbia, April 21, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO) (FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company along with its development partner CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), announce that ImQuest Biosciences has been engaged to expand in vitro and in vivo testing of WP1122, a drug candidate for the treatment of COVID-19.  The agreement with ImQuest Biosciences was entered into by WPD's license partner Moleculin Biotech, Inc. (NASDAQ:MBRX) ("Moleculin"), to expand testing of WP1122 as a potential treatment for the Coronavirus. WPD is not making any express or implied claims that this new partnership may eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus…

    VANCOUVER, British Columbia, April 21, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO) (FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company along with its development partner CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), announce that ImQuest Biosciences has been engaged to expand in vitro and in vivo testing of WP1122, a drug candidate for the treatment of COVID-19.  The agreement with ImQuest Biosciences was entered into by WPD's license partner Moleculin Biotech, Inc. (NASDAQ:MBRX) ("Moleculin"), to expand testing of WP1122 as a potential treatment for the Coronavirus. WPD is not making any express or implied claims that this new partnership may eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

    ImQuest BioSciences is a preclinical CRO that provides expert services to evaluate the potential of new and novel pharmaceutical products for the treatment and prevention of viruses, bacteria, cancer and inflammatory diseases. ImQuest has developed a robust platform to identify and support the development of therapeutic products to inhibit and prevent coronavirus infection. These preclinical research services are part of the ImQuestSUCCESS Platform and include compound screening to define compound efficacy and drug target validation to define the mechanism of action and toxicity of pharmaceutical products, as well as evaluation of the potential of products to induce resistance and the impact of combination antiviral therapy.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 30 countries in Europe and Asia, including Russia.

    About ImQuest BioSciences

    ImQuest BioSciences is a leading preclinical contract research and development organization (CRO) that provides services to evaluate the potential of new and novel pharmaceutical products for the treatment and prevention of infectious disease, cancer and inflammatory diseases. ImQuest provides expert preclinical research services and compound screening to define the efficacy, mechanism of action and toxicity of pharmaceutical products and specializes in the development of small molecules, natural products, biologics, antimicrobial peptides, therapeutic antibodies and vaccines for infectious disease and cancer drug development programs. The ImQuest team is committed to earning client's trust and building long term relationships through collaboration, unwavering commitment to quality science and consistent and effective communication.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WPD Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com 

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward looking statements in this press release include that engaging ImQuest should enable very fast turnaround on in vitro and in vivo testing for WP1122; that this may help facilitate the filing of an IND and/or a CTA submission; and that our drug compounds may be useful in treatment of certain types of cancer and/or Covid-19. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected.  Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law. 

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  62. VANCOUVER, British Columbia, April 09, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, is pleased to announce that independent research on its WP1122 drug compound found 2-deoxy-D-glucose ("2-DG") to reduce replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing. WPD in collaboration with its development partner CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP) intends to develop several preclinical drug candidates including WP1122, which will be tested on a range of viruses including the coronavirus SARS-CoV-2.

    WPD has licensed rights to a portfolio of drug candidates, including WP1122, through its license partner, Moleculin…

    VANCOUVER, British Columbia, April 09, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, is pleased to announce that independent research on its WP1122 drug compound found 2-deoxy-D-glucose ("2-DG") to reduce replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing. WPD in collaboration with its development partner CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP) intends to develop several preclinical drug candidates including WP1122, which will be tested on a range of viruses including the coronavirus SARS-CoV-2.

    WPD has licensed rights to a portfolio of drug candidates, including WP1122, through its license partner, Moleculin Biotech, Inc. ("Moleculin")(NASDAQ:MBRX). Recently, researchers at the University of Frankfurt disclosed the findings in their article submitted to NatureResearch on March 11, 2020 (Bojkova, D et al; DOI: 10.21203/rs.3.rs-17218/v1) (https://www.researchsquare.com/article/rs-17218/v1). The authors reported that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS-CoV–2 replication in Caco–2 cells.  Glycolysis is a process by which cells convert glucose into energy and infected (host) cells are induced by viruses to dramatically increase their dependence on glycolysis.  2-DG inhibits glycolysis because, although it appears to cells to be glucose, it is in fact a decoy that cannot be converted into energy.

    WP1122 is referred to as a "prodrug" of 2-DG whereby chemical elements are added to 2-DG to improve its delivery in vivo.  Once administered, these added elements are removed by normal metabolic processes and what remains is 2-DG. As a result, 2-DG is the active compound in WP1122.  In chemical terms, it is referred to as the active "moiety" (subpart) of WP1122.

    "We are excited with this breakthrough on our WP1122 drug candidate and the early implications are that it could have positive effects on reducing the spread of COVID-19," commented Mariusz Olejniczak, CEO of WPD. "I would like to commend our license partner, Moleculin and the researchers at the University of Frankfurt for their expedited work and the willingness of the authors to pre-release this data will help support our development of WP1122 for treating COVID-19."

    Walter Klemp, Chairman and CEO of Moleculin added: "This discovery essentially put our development efforts in to turbo-drive.  We are moving as quickly as we can to prepare WP1122 for clinical trials.  With the US and EU having established accelerated approval procedures for COVID-19 related projects, we expect this to move very quickly.  We look forward to WPD's help, especially as it relates to expediting things in Europe."

    According to WPD's license partner Moleculin, 2-DG is often referred to as the ‘active moiety' in WP1122.  The issue with 2-DG is that its often metabolized too quickly by the body, so human tissues and organs can't get enough concentration to be therapeutic.  Therefore, even though 2-DG is active against a range of viruses, including SARS-CoV-2, it isn't useful as a clinical therapy because it metabolizes too rapidly.  WP1122 works to solve this problem because it is a ‘prodrug' of 2-DG.  Its structure enables it to achieve much higher tissue/organ concentrations than 2-DG alone, but once it's in the cell, it metabolizes into the exact same 2-DG that is so effective in vitro.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company can develop effective drugs against cancer and possibly SARS Covid -19.  Factors which may prevent the forward looking statement from being realized include that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

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  63. VANCOUVER, British Columbia, March 24, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, announces it has entered into a development agreement (the "Agreement") with CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP) for the development of several preclinical drug candidates including WP1122, which will be tested on a range of viruses including the coronavirus SARS-CoV-2. 

    WPD has licensed rights to a portfolio of drug candidates, including WP1122, through its license partner, Moleculin Biotech, Inc. ("Moleculin")(NASDAQ:MBRX). Recently, Moleculin entered into an agreement with a leading government funded research facility in the United States to conduct research…

    VANCOUVER, British Columbia, March 24, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD") a clinical stage pharmaceutical company, announces it has entered into a development agreement (the "Agreement") with CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP) for the development of several preclinical drug candidates including WP1122, which will be tested on a range of viruses including the coronavirus SARS-CoV-2. 

    WPD has licensed rights to a portfolio of drug candidates, including WP1122, through its license partner, Moleculin Biotech, Inc. ("Moleculin")(NASDAQ:MBRX). Recently, Moleculin entered into an agreement with a leading government funded research facility in the United States to conduct research on its patented portfolio of molecular inhibitors, including drug candidate, WP1122, for antiviral properties against a range of viruses, including Coronavirus. WP1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG's lack of drug-like properties and is able to significantly improve tissue/organ concentration.

    Under the CNS Agreement, WPD will receive a portion of the development costs from CNS for WP1122 and other drug candidates for antiviral indications, and CNS will receive certain economic rights. WPD received an upfront cash payment from of $225,000 and CNS has committed to a milestone payment of $775,000 upon the successful completion of a Phase 2 study.  In return for the funding, CNS is entitled to receive 50% of the net sales of resulting commercial products in WPD's 31 licensed territories, but  Poland may become exempted from the list on certain milestones being achieved. Those 31 territories include countries in Europe and Asia, and include Russia. 

    Mariusz Olejniczak, CEO of WPD commented, "We look forward to partnering with CNS through this Agreement for the development of antiviral drug candidates, including WP1122. We are grateful to be able to join forces with them and help the urgent fight against deadly viral infections such as the coronavirus that causes Covid-19."

    The Company also announces it has retained 1157667 BC Ltd. as corporate advisors and has granted them 500,000 options at $0.86.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future.  These forward-looking statements include that we will use the funds from CNS to help the urgent fight against coronavirus and that we can attain all the additional funding of $775,000.  Factors which may prevent the forward looking statement from being realized is that we don't reach milestones required and don't receive any additional funds from CNS; that our research does not result in any advance against viral diseases; that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

     

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  64. HOUSTON, March 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company primarily specializing in the development of novel treatments for cancers of the brain and central nervous system, announces it has entered into an agreement with WPD Pharmaceuticals Inc. (CSE:WBIO) for the development of several preclinical drug candidates including WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories. WPD Pharmaceuticals was founded by Dr. Waldemar Priebe, the founder of the Company.

    HOUSTON, March 23, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company primarily specializing in the development of novel treatments for cancers of the brain and central nervous system, announces it has entered into an agreement with WPD Pharmaceuticals Inc. (CSE:WBIO) for the development of several preclinical drug candidates including WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories. WPD Pharmaceuticals was founded by Dr. Waldemar Priebe, the founder of the Company.

    According to WPD Pharmaceuticals, WP1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG's lack of drug-like properties and is able to significantly increase tissue/organ concentration.

    "We are pleased to expand our relationship with WPD Pharmaceuticals and to broaden our product pipeline to include antiviral drug candidates," commented John M. Climaco, CEO of CNS Pharmaceuticals. "While our primary focus remains in oncology, given our expertise in working with compounds like WP1122 we are grateful to be able to help in the urgent fight against deadly viral infections such as the coronavirus that causes Covid-19. This agreement complements our existing clinical programs by expanding our potential market opportunities."

    Under the terms of the agreement, CNS agreed to fund a portion of the development costs of WP1122 and other drug candidates for antiviral indications in exchange for certain economic rights. CNS made an upfront cash payment of $225,000 and committed to a milestone payment of $775,000 to WPD Pharmaceuticals upon the successful completion of a Phase 2 study. In return, CNS is entitled to receive 50% of the net sales, less WPD's license costs, of resulting commercial products in WPD's licensed territories, other than Poland. Those territories include 29 countries in Europe and Asia, including Russia.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments primarily for cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006. In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD Pharmaceuticals to develop the drug candidates subject to the development agreement. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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    SOURCE CNS Pharmaceuticals, Inc.

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  65. HOUSTON, March 12, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced business highlights and financial results for the three months ended December 31, 2019 and Fiscal Year 2019.

    Business highlights for the fourth quarter of 2019 and recent weeks include the following:

    • Selected a leading Polish institution for the Phase 1 pediatric trial with Berubicin in glioblastoma multiforme ("GBM"). In February 2020, CNS announced the selection of Children's Memorial Health Institute, the largest pediatric hospital in Poland as the single site for this pediatric trial which is expected to commence in the second half of 2020.
    • Completed final Good Manufacturing Practice ("GMP") reprocessing and purity validation of the existing batch of its lead drug candidate Berubicin. In February 2020, the Company announced the final GMP reprocessing of the existing batch of Berubicin, reporting the GMP material met all specifications and analytical testing is now underway. The Company is continuing large-scale production of Berubicin and intends to utilize this supply to complete its planned Phase 2 clinical trial for patients with GBM.
    • Licensed a novel DNA-binding technology from The University of Texas MD Anderson Cancer Center to expand the clinical pipeline. In January 2020, CNS entered into a licensing agreement with MD Anderson, granting the Company rights to develop and commercialize WP1244, a new class of DNA-binding agent designed to cross the blood-brain barrier for the potential treatment of primary and metastatic brain cancers. WP1244 has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
    • Received positive feedback from the U.S. Food and Drug Administration ("FDA") for Pre-IND (Investigational New Drug) proposal. In its December 2019 positive response to the Company's Pre-IND request, the FDA indicated that the proposal to use a previously manufactured and currently available supply of a lyophilized drug product (i.e., Berubicin) in the Phase 2 clinical trial appears reasonable. Furthermore, the FDA noted that the requested dosage regimen for the planned Phase 2 trial with Berubicin in GBM, which will be based on the Reata Phase 1 trial, was reasonable.
    • Closed initial public offering ("IPO") of common stock. The Company closed its IPO of 2,125,000 shares of common stock at an offering price of $4.00 per share on November 13, 2019 and an additional 318,750 shares pursuant to the exercise in full of the underwriters' over-allotment option sold at the IPO price of $4.00 per share on November 20, 2019. Gross proceeds from the offering, including the exercise of the underwriters' over-allotment option, were $9.8 million and will be used to fund CNS' clinical trials and for working capital.

    "Since completing our IPO we are very pleased with the progress we have made toward initiating our Phase 2 clinical study of Berubicin to treat GBM, which represents a significant unmet medical need," stated John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals.  "We believe Berubicin has the ability to cross the blood-brain barrier with positive responses in these types of tumors, as demonstrated in the Phase 1 study conducted by Reata. In the second half of this year, we look forward to initiating our Phase 2 clinical study in adults in the U.S., as well as two studies conducted in Poland by our sub-license partner, WPD Pharmaceuticals, including a Phase 2 study in adults which will mirror our U.S.-based study, and a first-ever Phase 1 study in children. In addition, we plan to perform further preclinical studies for our recently licensed WP1244 drug candidate, a novel and potent DNA binding agent with high potency to inhibit tumor cell proliferation."

    Fourth Quarter Financial Results

    General and administrative expense was $1.0 million for the fourth quarter of 2019, compared with $0.2 million for the prior-year period. The increase is largely attributable to the expanded corporate infrastructure implemented in order to advance the Company's clinical development program following its IPO.

    Research and development expense for the fourth quarter of 2019 was $1.5 million, compared with $0 for the fourth quarter of 2018. The expense in the quarter was largely related to the cost of reprocessing and validating the existing batch of Berubicin needed for the commencement of the Phase 2 clinical trial, as well as starting the production of a new batch of the drug necessary for the contemplated clinical trials, both in the U.S. and in Poland.

    The net change in cash in the fourth quarter of 2019 was $6.3 million. As of December 31, 2019, CNS had cash and cash equivalents of $7.2 million, which includes $8.8 million in net proceeds from our IPO.

    Conference Call

    CNS senior management will provide a business update in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, March 12, 2020. The conference call dial-in and webcast information is as follows:

    DOMESTIC DIAL-IN:

    (844) 535-4071                  

    INTERNATIONAL DIAL-IN:

    (706) 679-2458

    PASSCODE:

    1254059

    WEBCAST:

    CNS Business Update Conference Call.

    For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056   or 404-537-3406. The replay passcode is 1254059. The replay can be accessed for a period of time on the CNS website at CNS Business Update Conference Call.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of Berubicin in the United States and Poland. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CNS Pharmaceuticals, Inc.

    Statements of Operations




    Year Ended
    Dec. 31, 2019



    Year Ended
    Dec. 31, 2018



    3 Mon. Ended
    Dec. 31, 2019



    3 Mon. Ended
    Dec. 31, 2018
































    Operating expenses:

















    General and administrative


    $

    1,978,643



    $

    860,520



    $

    1,039,337



    $

    208,583


    Research and development



    1,854,334




    21,267




    1,484,394






















    Total operating expenses



    3,832,977




    881,787




    2,523,731




    208,583



















    Loss from operations



    (3,832,977)




    (881,787)




    (2,523,731)




    (208,583)



















    Other expense:

















    Loss on settlement of liabilities






    (6,286,841)







    (6,286,841)


    Loss on change in fair value of SAFE agreements






    (122,120)







    (122,120)


    SAFE agreement expenses






    (54,454)








    Interest expense



    (26,152)




    (28,615)




    (3,617)




    (10,632)


    Amortization of debt discount



    (18,082)




    (18,082)







    (3,337)


    Total other expense



    (44,234)




    (6,510,112)




    (3,617)




    (6,422,930)



















    Net loss


    $

    (3,877,211)



    $

    (7,391,899)



    $

    (2,527,348)



    $

    (6,631,513)



















    Loss per share - basic and diluted


    $

    (0.28)



    $

    (0.70)



    $

    (0.17)



    $

    (0.63)


    Weighted average shares outstanding - basic and diluted



    13,647,908




    10,510,551




    15,072,760




    10,536,004


     

    CNS Pharmaceuticals, Inc.

    Balance Sheets




    December 31,
    2019



    December 31,
    2018









    Assets









    Current Assets:









    Cash and cash equivalents


    $

    7,241,288



    $

    282,736


    Restricted cash






    272,397


    Prepaid expenses



    652,622




    33,000


    Total current assets



    7,893,910




    588,133











    Fixed Assets









    Furniture and equipment, net



    18,165














    Long-Term Assets:









    Deferred issuance costs






    95,200











    Total Assets


    $

    7,912,075



    $

    683,333











    Liabilities and Stockholders' Deficit


















    Current Liabilities:









    Accounts payable


    $

    243,666



    $

    128,071


    Accounts payable and accrued expenses - related party



    45,833




    794


    Accrued expenses



    21,500




    23,599


    Convertible notes payable, net of discount






    281,918


    Notes payable






    35,000


    SAFE agreements






    763,249


    Total current liabilities



    310,999




    1,232,631











    Total Liabilities



    310,999




    1,232,631











    Commitments and contingencies


















    Stockholders' Equity (Deficit):









    Preferred stock, $0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding







    Common stock, $0.001 par value, 75,000,000 shares authorized and 16,450,234 and 12,694,504 shares issued and outstanding, respectively



    16,450




    12,695


    Additional paid-in capital



    19,073,098




    7,049,268


    Accumulated deficit



    (11,488,472)




    (7,611,261)


    Total Stockholders' Equity (Deficit)



    7,601,076




    (549,298)











    Total Liabilities and Stockholders' Equity (Deficit)


    $

    7,912,075



    $

    683,333


     

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    SOURCE CNS Pharmaceuticals, Inc.

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  66. HOUSTON, March 5, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, plans to report financial results for the three and 12 months ended December 31, 2019, after the close of the U.S. financial markets on Thursday, March 12, 2020.

    CNS' senior management will provide a business update in a conference call and live audio webcast at 4:30 p.m. Eastern time on Thursday, March 12, 2020. The conference call dial-in and webcast information is as follows:

    DOMESTIC DIAL-IN:

    (844) 535-4071

    INTERNATIONAL DIAL-IN:

    (706) 679-2458

    PASSCODE:

    1254059

    WEBCAST:

    CNS Business Update Conference Call

    For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1254059. The replay can be accessed for a period of time on CNS website at CNS Business Update Conference Call.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

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    SOURCE CNS Pharmaceuticals, Inc.

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  67. VANCOUVER, British Columbia, March 04, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD"), a clinical stage pharmaceutical company, is pleased to provide an update that through its license partner, CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP), it received positive feedback from the U.S. Food and Drug Administration ("FDA") for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials. 

    Berubicin was developed at the largest cancer treatment and research institute in the world, and has been shown to get across the blood brain barrier and kill brain tumor cells not reachable by other therapies. Berubicin may become an effective…

    VANCOUVER, British Columbia, March 04, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD"), a clinical stage pharmaceutical company, is pleased to provide an update that through its license partner, CNS Pharmaceuticals, Inc. ("CNS")(NASDAQ:CNSP), it received positive feedback from the U.S. Food and Drug Administration ("FDA") for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials. 

    Berubicin was developed at the largest cancer treatment and research institute in the world, and has been shown to get across the blood brain barrier and kill brain tumor cells not reachable by other therapies. Berubicin may become an effective treatment against glioblastoma, the most aggressive type of brain cancer.

    In its positive response to the previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.

    Mariusz Olejniczak, CEO of WPD, commented, "The positive feedback from the FDA is encouraging as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide. We believe in Berubicin's potential to offer oncologists the only anthracycline effective against brain cancer."

    Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer. 

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 30 countries in Europe and Asia, including Russia.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future.  Forward-looking statements in this press release include that our findings could have a significant impact on understanding the role of STAT3 inhibition and that WPD's drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected.  Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

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  68. HOUSTON, March 3, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme ("GBM"), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease.

    In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out…

    HOUSTON, March 3, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme ("GBM"), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease.

    In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.  

    "We are delighted to provide this update on Berubicin's potential capabilities given the unmet need for this aggressive disease," commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals.  "We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children's Memorial Health Institute, the largest pediatric hospital in Poland." WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company.  

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of GBM, an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.  For more information, please visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to initiates its Phase 2 clinical trial in the second half of this year, and the ability of WPD Pharmaceuticals to commence a Phase 1 trial in children later this year. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  69. HOUSTON, Feb. 27, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced the Company's Chief Executive Officer John Climaco will ring the opening bell of The Nasdaq Stock Market on Tuesday, March 3, 2020, at 9:30 a.m. Eastern time.

    "We are honored to be ringing the Nasdaq opening bell to celebrate our initial public offering, which we closed late last year," said Mr. Climaco. "Since going public we have made significant progress in preparing the Investigational New Drug application for our lead drug candidate Berubicin to treat glioblastoma…

    HOUSTON, Feb. 27, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced the Company's Chief Executive Officer John Climaco will ring the opening bell of The Nasdaq Stock Market on Tuesday, March 3, 2020, at 9:30 a.m. Eastern time.

    "We are honored to be ringing the Nasdaq opening bell to celebrate our initial public offering, which we closed late last year," said Mr. Climaco. "Since going public we have made significant progress in preparing the Investigational New Drug application for our lead drug candidate Berubicin to treat glioblastoma multiforme, an aggressive brain cancer. In addition, we added to our clinical program a second drug candidate, WP1244, a novel DNA binding agent. I want to thank our employees, directors, clinical advisors and shareholders for supporting our mission to be a leading developer of organ-targeted cancer therapeutics."

    To view a live stream of the Nasdaq Opening Bell ceremony, please visit Nasdaq's MarketSite here.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 trial with Berubicin in GBM which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. In the second half of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

    Forward-Looking Statements
    Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare the Investigational New Drug application for its lead drug candidate Berubicin to treat glioblastoma multiforme. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in the Company's SEC filings, including under the heading "Risk Factors" in the Form S-1 filed on October 7, 2019. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  70. VANCOUVER, British Columbia, Feb. 12, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD"), a clinical stage pharmaceutical company, is pleased to announce its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.

    The Company, in collaboration with CNS, is planning to conduct the upcoming Phase I clinical trial at Children's Memorial Health Institute ("Children's Memorial"), the largest pediatric hospital in Poland. The Company believes this Phase…

    VANCOUVER, British Columbia, Feb. 12, 2020 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE:WBIO)(FSE: 8SV1) (the "Company" or "WPD"), a clinical stage pharmaceutical company, is pleased to announce its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS"), a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.

    The Company, in collaboration with CNS, is planning to conduct the upcoming Phase I clinical trial at Children's Memorial Health Institute ("Children's Memorial"), the largest pediatric hospital in Poland. The Company believes this Phase I trial of Berubicin at Children's Memorial represents the first ever investigation of an anthracycline and topoisomerase II inhibitor in pediatric brain tumors. WPD and CNS are currently working with experts at Children's Memorial to complete documentation for the upcoming study and scientific advice meeting.

    As previously announced, WPD and CNS entered into a sublicense agreement which granted WPD commercial rights in a limited territory to Berubicin, including research and development. Subsequently, WPD was awarded a $6 million grant from the EU/Polish National Center for Research and Development. WPD plans to utilize funds from the grant to fund the upcoming Phase I trial and has the full support from CNS to execute these studies.

    Mariusz Olejniczak, CEO of WPD Pharmaceuticals, commented, "We are very excited to initiate a Phase I clinical trial and further expand the scope of Berubicin. We look forward our collaboration with CNS and Children's Memorial in Poland to initiate what we believe to be the first investigation of a unique topoisomerase II inhibitor that appears to be able to cross the blood-brain barrier in pediatric brain tumors.  We will continue to drive the clinical development of Berubicin in the upcoming Phase II trial in adult patients."

    About Berubicin

    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

    About WPD Pharmaceuticals

    WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including MD Anderson Cancer Center, Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

    WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.

    On Behalf of the Board

    ‘Mariusz Olejniczak'

    Mariusz Olejniczak
    CEO, WDP Pharmaceuticals

    Contact:

    Investor Relations
    Email: investors@wpdpharmaceuticals.com
    Tel: 604-428-7050
    Web: www.wpdpharmaceuticals.com

    Cautionary Statements:

    Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

    This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future.  Forward-looking statements in this press release include that we will conduct Phase I clinical trial at Children's Memorial pediatric hospital in collaboration with CNS;  that clinical development of Berubicin will continue in the upcoming Phase II trial in adult patients and that WPD's drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Company's current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected.  Factors which may prevent the forward looking statement from being realized is that the plans to complete Phase I or Phase II clinical trials are disrupted; that Phase II does not occur because of a failure during Phase I; that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that our drugs don't provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com.  Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate.  Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

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  71. HOUSTON, Feb. 11, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with WPD Pharmaceuticals, Inc. (CSE:WBIO) ("WPD"), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company.

    The Company, in collaboration with WPD, will conduct the upcoming Phase I clinical trial at Children's Memorial Health Institute ("Children's Memorial"), the largest pediatric hospital in Poland. The Company believes this Phase I trial of Berubicin at Children's Memorial represents the first…

    HOUSTON, Feb. 11, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with WPD Pharmaceuticals, Inc. (CSE:WBIO) ("WPD"), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company.

    The Company, in collaboration with WPD, will conduct the upcoming Phase I clinical trial at Children's Memorial Health Institute ("Children's Memorial"), the largest pediatric hospital in Poland. The Company believes this Phase I trial of Berubicin at Children's Memorial represents the first ever investigation of an anthracycline and topoisomerase II inhibitor in pediatric brain tumors. WPD and CNS are currently working with Children's Memorial to complete documentation for the upcoming study and EMA scientific advice meeting.

    As previously announced, CNS entered into a sublicense agreement with WPD which granted WPD commercial rights in a limited territory to Berubicin, including research and development. Subsequently, WPD was awarded a $6 million grant from the EU/Polish National Center for Research and Development. WPD plans to utilize funds from the grant to fund the upcoming Phase I trial and CNS is committed to fully support these studies with its internal expertise.

    "We are extremely excited to further expand the scope of Berubicin and potentially bring a new hope for pediatric brain tumor patients in Poland and subsequently around the world," stated John Climaco, CEO of CNS Pharmaceuticals. "We look forward to initiating what we believe to be the first investigation of a unique topoisomerase II inhibitor that appears to be able to cross the blood-brain barrier in pediatric brain tumors as we continue to drive the clinical development of Berubicin in the upcoming Phase II trial in adult patients."

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of Berubicin in the United States and Poland. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

     

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  72. HOUSTON, Feb. 4, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals, Inc. (Reata), and that the GMP material has met all specifications.  

    Samples of the lyophilized drug product were shipped to Intertek Pharmaceutical Services (Intertek), for final GMP testing. The pilot recrystallization run met all specifications and the initial GMP run passed all specifications; however, it was discovered that one of the standard 10 metals in Heavy Metals Test, bismuth, was not officially…

    HOUSTON, Feb. 4, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals, Inc. (Reata), and that the GMP material has met all specifications.  

    Samples of the lyophilized drug product were shipped to Intertek Pharmaceutical Services (Intertek), for final GMP testing. The pilot recrystallization run met all specifications and the initial GMP run passed all specifications; however, it was discovered that one of the standard 10 metals in Heavy Metals Test, bismuth, was not officially validated for that assay. This did not prevent the formulation of the final drug product. Subsequently, heavy metals including bismuth were again tested and met all specifications. Additionally, the Company is continuing large scale production of Berubicin through NCK A/S. The Company intends to utilize this supply of Berubicin for its potential upcoming Phase II clinical trial in Glioblastoma.

    "Completing GMP Manufacturing represents another pivotal step in our Berubicin production," stated John Climaco, CEO of CNS Pharmaceuticals. "We are excited to continue our productive start to 2020 by completing another manufacturing milestone and look forward to further advancing both the production and clinical development of our lead candidate. We hope to continue our manufacturing success and utilize our supply of Berubicin for upcoming clinical trials and commercial use."

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  73. HOUSTON, Jan. 28, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

    As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the…

    HOUSTON, Jan. 28, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

    As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company's upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.

    "We are excited to achieve another important milestone in the development of Berubicin," stated John Climaco, CEO of CNS Pharmaceuticals. "We look forward to completing both GMP manufacturing processes and release for clinical trials."

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata. 

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive a COA for the GMP reprocessed API, and to achieve the large-scale production of Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  74. HOUSTON, Jan. 14, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has signed a contract with NCK A/S for the large scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.

    NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. Production of large scale Berubicin is set to commence in January and will ensure drug availability through the end of Phase II clinical trials for glioblastoma.

    "We are extremely excited to have entered into a contract with NCK A/S. We believe working…

    HOUSTON, Jan. 14, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has signed a contract with NCK A/S for the large scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.

    NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. Production of large scale Berubicin is set to commence in January and will ensure drug availability through the end of Phase II clinical trials for glioblastoma.

    "We are extremely excited to have entered into a contract with NCK A/S. We believe working with an experienced company in the production of this class of anthracyclines is paramount given the complex chemistry and difficulty to produce very high purity for human use," stated John Climaco, CEO of CNS Pharmaceuticals. "We are confident in NCK A/S' ability to succeed in the large scale production of our lead candidate due to its extensive experience in Berubicin synthesis for previous clinical trials. This contract represents a key stride in the development of Berubicin and secures drug availability as we look forward not only to initiate but also expand Phase II clinical trials later this year."

    About Berubicin
    Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.  Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.  Berubicin was developed at the MD Anderson Cancer Center (MDACC), which is the top ranked cancer center in the US, and largest cancer research and treatment facility in the world.  Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata. 

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to commence its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  75. HOUSTON, Jan. 13, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has entered into a licensing agreement with MD Anderson to investigate WP1244, an entirely new class of DNA-binding agents designed to cross the blood brain barrier for the potential the treatment of primary and metastatic brain cancers.

    This agreement marks the Company's first direct relationship with MD Anderson, the largest cancer research and treatment institute in the world, and allows for the continued development of WP1244, a new class of DNA-binding agents shown to have high anti-tumor activity. WP1244 was designed using…

    HOUSTON, Jan. 13, 2020 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has entered into a licensing agreement with MD Anderson to investigate WP1244, an entirely new class of DNA-binding agents designed to cross the blood brain barrier for the potential the treatment of primary and metastatic brain cancers.

    This agreement marks the Company's first direct relationship with MD Anderson, the largest cancer research and treatment institute in the world, and allows for the continued development of WP1244, a new class of DNA-binding agents shown to have high anti-tumor activity. WP1244 was designed using a "modular" strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Previous pre-clinical tests have demonstrated the agent's ability to cross the blood barrier in animal models with no acute clinically observable toxicity. The Company is currently collaborating with MD Anderson on terms to conduct a sponsored research agreement of this novel class of agent.

    "Our licensing agreement with MD Anderson has allowed CNS to double its portfolio with the addition of WP1244. We are extremely excited to continue the investigation of this entirely new class of DNA-binding agent in our first direct relationship with MD Anderson," stated CEO of CNS, John M. Climaco. "We believe the compound demonstrates enormous potential through its novel mechanism of action, ability to cross the blood-brain barrier, and tremendous potency, 500 times that of classic DNA binding agents such as daunorubicin. WP1244 has shown to be mechanistically and biologically novel and selective, and its addition to our pipeline furthers our goal of being the leading developer of organ-targeted cancer therapeutics. We look forward to both furthering the clinical development of WP1244 and deepening our relationship with MD Anderson through a sponsored research agreement."

    About WP1244
    WP1244 is a novel DNA binding agent with relatively high molecular weight (981.3 MW) having a polyamide moiety attached to the amino sugar. WP1244 is exceedingly potent having in vitro IC50 values in the subnanomolar range and is currently being studied for its therapeutic potential in preclinical studies. A previous 5-mice pilot study performed with WP1244 confirmed the presence of WP1244 in murine brain tissue. WP1244 was designed utilizing a "modular" design strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Pre-clinical studies of WP1244 have demonstrated its potential ability to cross the blood-brain barrier in animal models. WP1244 was developed at the MD Anderson Cancer Center in the Department of Experimental Therapeutics as a collaborative effort with the Neuro-Oncology Department and Pharmaceutical Development Center.

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors.  Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas.  The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata.  For more information, visit www.cnspharma.com.

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of WP1244. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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  76. HOUSTON, Dec. 17, 2019 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, ("Anthem") an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.

    This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company's Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized…

    HOUSTON, Dec. 17, 2019 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, ("Anthem") an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.

    This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company's Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.

    In its response to the Company's Pre-IND request, the FDA agreed that CNS' proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company's proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA's guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS' existing supply of Berubicin.

    "We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply," stated CEO of CNS, John M. Climaco. "The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin's potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer."

    About Berubicin
    Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer. 

    About CNS Pharmaceuticals, Inc.
    CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com

    Forward-Looking Statements
    Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

     

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  77. HOUSTON, Dec. 11, 2019 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that its partner, WPD Pharmaceuticals ("WPD"), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company, was awarded a $5,798,875 grant from the EU/Polish National Center for Research and Development under the Smart Growth Operational Program 2014-2020 (the "EU Grant").

    The Company previously entered into a sublicense agreement with WPD, in which WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin over a three –year period. WPD's…

    HOUSTON, Dec. 11, 2019 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that its partner, WPD Pharmaceuticals ("WPD"), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company, was awarded a $5,798,875 grant from the EU/Polish National Center for Research and Development under the Smart Growth Operational Program 2014-2020 (the "EU Grant").

    The Company previously entered into a sublicense agreement with WPD, in which WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin over a three –year period. WPD's subsequent development project, "New approach to glioblastoma treatment addressing the critical unmet medical need" (the "WPD Project"), received the grant co-financed by the European Union under the Smart Growth Operational Program 2014-2020, Priority I: Support for Research and Development work by Enterprises, Measure 1.2: Sectorial Research and Development Programs, Sectorial Program InnoNeuroPharm.