BPTH Bio-Path Holdings Inc.

4.11
+0.16  (+4%)
Previous Close 3.95
Open 3.95
52 Week Low 2.9203
52 Week High 13.342
Market Cap $15,173,532
Shares 3,691,857
Float 3,657,863
Enterprise Value $1,135,532
Volume 38,839
Av. Daily Volume 207,255
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Drug Pipeline

Drug Stage Notes
BP1002
Refractory/relapsed lymphoma and chronic lymphocytic leukemia
Phase 1
Phase 1
Phase 1 trial planned.
Prexigebersen
Solid tumors
Phase 1
Phase 1
Phase 1 trial to commence in 2H 2020.
Prexigebersen - BP1001 + Decitabine + Venetoclax
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Phase 2
Phase 2
Phase 2 commencement of Stage 2 dosing announced August 13, 2020.
INOpulse Inhaled Nitric Oxide
COVID-19
Phase 3
Phase 3
Phase 3 trial initiation announced May 11, 2020.

Latest News

  1. HOUSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that Peter H. Nielsen, Chief Executive Officer, will present a corporate overview at the upcoming virtual H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:30 a.m. ET.

    A live webcast of the presentation can be accessed under "Events" in the Media section of the Company's website at www.biopathholdings.com.

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded…

    HOUSTON, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that Peter H. Nielsen, Chief Executive Officer, will present a corporate overview at the upcoming virtual H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:30 a.m. ET.

    A live webcast of the presentation can be accessed under "Events" in the Media section of the Company's website at www.biopathholdings.com.

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies.

    For more information, please visit the Company's website at http://www.biopathholdings.com.

    Contact Information:

    Investors

    Will O'Connor

    Stern Investor Relations

    212-362-1200

     

    Doug Morris

    Investor Relations

    Bio-Path Holdings, Inc.

    832-742-1369

    Primary Logo

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  2. HOUSTON, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the second quarter ended June 30, 2020 and provided an update on recent corporate developments.

    "Despite the challenges from the COVID-19 pandemic, we were able to continue to make significant progress across our clinical development pipeline. Most importantly, as recently announced, we dosed the first patient in Stage 2 of our Phase 2 trial of prexigebersen as a combination treatment for patients suffering with acute myeloid leukemia (AML)," said Peter…

    HOUSTON, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the second quarter ended June 30, 2020 and provided an update on recent corporate developments.

    "Despite the challenges from the COVID-19 pandemic, we were able to continue to make significant progress across our clinical development pipeline. Most importantly, as recently announced, we dosed the first patient in Stage 2 of our Phase 2 trial of prexigebersen as a combination treatment for patients suffering with acute myeloid leukemia (AML)," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We believe that this unique clinical trial design offers multiple potential paths to registration. We are encouraged by earlier safety and efficacy data that prexigebersen in combination with latest standard of care should significantly enhance patient outcomes in AML patients who otherwise have limited treatment options."

    "As we look to the balance of the year, we will continue to advance our studies for prexigebersen and BP-1002. We look forward to initiating a Phase 1 study of prexigebersen for the treatment of solid tumors by year end and remain steadfast in our goal to bring these potentially lifesaving therapies to patients in need," continued Mr. Nielsen.

    Recent Corporate Highlights

    • Announced First Patient Dosed in Amended Stage 2 of the Phase 2 Clinical Trial Evaluating Prexigebersen in Acute Myeloid Leukemia. On August 13, 2020, Bio-Path announced the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of AML in combination with frontline therapy decitabine and venetoclax. 

       
    • Presented at the 2020 American Society of Clinical Oncology Annual Meeting. In May, Bio-Path presented a virtual poster presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center, discussed the Phase 2 study design of BP1001 (liposomal Grb2 antisense), Bio-Path's lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with AML or high-risk myelodysplastic syndrome. 

    Financial Results for the Second Quarter Ended June 30, 2020

    • The Company reported a net loss of $2.0 million, or $0.55 per share, for the three months ended June 30, 2020, compared to a net loss of $2.5 million, or $0.87 per share, for the three months ended June 30, 2019.

       
    • Research and development expenses for the three months ended June 30, 2020 decreased to $1.0 million, compared to $1.5 million for the three months ended June 30, 2019 primarily due to timing of activities related to our Phase 2 clinical trial of prexigebersen in AML.

       
    • General and administrative expenses for the three months ended June 30, 2020 were $1.0 million, consistent with the comparable period in 2019.

       
    • As of June 30, 2020, the Company had cash of $14.4 million, compared to $20.4 million at December 31, 2019.  Net cash used in operating activities for the six months ended June 30, 2020 was $6.0 million compared to $4.2 million for the comparable period in 2019. 

    Conference Call and Webcast Information

    Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2020 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 3237808. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company's website at www.biopathholdings.com.

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies.

    For more information, please visit the Company's website at http://www.biopathholdings.com.  

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, Bio-Path's ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10- K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact Information:

    Investors

    Will O'Connor

    Stern Investor Relations, Inc.

    212-362-1200

    Doug Morris

    Investor Relations

    Bio-Path Holdings, Inc.

    832-742-1369

    Primary Logo

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  3. HOUSTON, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapy decitabine and venetoclax. 

    As previously reported, Phase 2 clinical development of prexigebersen in AML commenced with Stage 1 of the Phase 2 clinical trial, which was open label and treated de novo AML patients with a combination of prexigebersen…

    HOUSTON, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapy decitabine and venetoclax. 

    As previously reported, Phase 2 clinical development of prexigebersen in AML commenced with Stage 1 of the Phase 2 clinical trial, which was open label and treated de novo AML patients with a combination of prexigebersen and low dose cytarabine (LDAC).  The combination of prexigebersen and LDAC was shown to be safe and more efficacious to treat this class of patients than with LDAC alone.  Despite the superior combination treatment results with LDAC, the new drug decitabine was favored by oncologists. As a result, Stage 2 of the Phase 2 trial in AML dropped the combination treatment of prexigebersen and LDAC and replaced it with the combination treatment prexigebersen and decitabine.  In addition, a second cohort of relapsed/refractory AML patients was added.

    The recent approval of the frontline therapy venetoclax provided an opportunity for adding prexigebersen to the newly approved frontline, two-drug combination of venetoclax and decitabine for the treatment of AML patients.   

    Prior to finalizing plans to include prexigebersen with the frontline treatment combination of decitabine and venetoclax, the Company performed preclinical testing in AML cancer cell lines to assess prexigebersen's increased benefit to efficacy.  Preclinical testing of prexigebersen with the frontline treatment of decitabine and venetoclax demonstrated the potential to enhance efficacy of the frontline treatment combination.  In the studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen (BP1001).  Decrease in AML cell viability was the primary measure of efficacy.   The triple combination of decitabine, venetoclax and BP1001 showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, the Company believes that adding prexigebersen to the treatment combination of decitabine and venetoclax could lead to improved efficacy in AML patients.

     % Decrease in Cell Viability
    AML Cell LinesBP1001 + decitabineBP1001 + decitabine + venetoclaxControla + decitabine + venetoclax
    KG-1649046
    MOLM-138610088
    MV-4-11679579
    Kasumi-1335047

    a Empty liposomes control

    Bio-Path's approved amended Stage 2 for this Phase 2 clinical trial has three cohorts of patients, which the Company believes provides for several potential regulatory pathways.  The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax.  The first cohort will include untreated AML patients, and the second cohort will include relapsed/refractory AML patients.  Finally, the third cohort will treat relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.  

    The first step in establishing the amended Stage 2 of the Phase 2 trial in AML was demonstrating the safety of treating patients with the two-drug combination of prexigebersen and decitabine, which the Company previously reported has been successfully completed.  Importantly, results from patients who were previously treated with the two-drug combination of prexigebersen and decitabine prior to the amendment to Stage 2 of the Phase 2 trial in AML and who meet the criteria for enrollment in the third cohort of the amended Stage 2 of the Phase 2 trial in AML can be included in the third cohort results.  This represents a beneficial head-start in the third cohort enrollment.  This third cohort represents a significant, unmet opportunity in clinical treatment, as options are limited for AML patients who fail frontline therapy.

    The first six evaluable patients in the amended Stage 2 of the Phase 2 trial in AML will be treated with the triple combination of prexigebersen, decitabine and venetoclax to test the safety of this treatment combination.  As noted previously, the enrollment and dosing of the first patient in the amended Stage 2 of the Phase 2 clinical study has occurred.  This patient is in the relapsed/refractory cohort being treated with the triple combination of prexigebersen, decitabine and venetoclax.

    "Despite recent advances in the field, AML continues to be a challenging malignancy with unmet medical need as most patients unfortunately eventually succumb to their disease. The potential for prexigebersen in combination with new standard of care treatments seems particularly promising.  We look forward to the execution of this trial and, hopefully, to bringing another tool to bear in the fight against this deadly disease," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

    "We are excited to be testing prexigebersen in this promising triple combination.  Given our preclinical data, which support treating AML patients with this triple combination, we believe there is strong potential for improved outcomes for patients with AML who otherwise have limited treatment options," said Peter Nielsen, President and Chief Executive Officer of BioPath Holdings. 

    "We believe that this unique trial design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapy," concluded Mr. Nielsen.    

    Study Design

    The amended Stage 2 of this Phase 2 trial in AML is an open label Phase 2, two-stage, multicenter study of prexigebersen in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and relapsed/resistant AML.  A third cohort includes treating relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

    The full trial design-plans have approximately 54 evaluable patients for the cohort treating relapsed/refractory AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax and the cohort treating AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine, with a review of both cohorts performed after 19 evaluable patients. 

    The full trial design-plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment of prexigebersen, decitabine and venetoclax, with a preliminary review for the cohort performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients.  The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy.

    The primary endpoint for this study will be the number of patients who achieve complete remission ("CR"), which includes complete remission with incomplete hematologic recovery ("CRi"), and complete remission with partial hematology recovery ("CRh").

    An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment.  In the event these results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company plans to seek to convert the trial into a registration trial for accelerated approval.

    The study is anticipated to be conducted at ten clinical sites in the U.S., and Gail J. Roboz, M.D., will be the national coordinating Principal Investigator for the Phase 2 trial.  Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City.   For more information on the Phase 2 study, visit www.clinicaltrials.gov.

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies.

    For more information, please visit the Company's website at http://www.biopathholdings.com.  

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, Bio-Path's ability to raise needed additional capital on a timely basis in order for it to continue its operations, Bio-Path's ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing for future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, risks relating to maintaining Bio-Path's listing on the Nasdaq Capital Market and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10- K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact Information:

                                       

    Investors

    Will O'Connor

    Stern Investor Relations, Inc.

    212-362-1200

    Doug Morris

    Investor Relations

    Bio-Path Holdings, Inc.

    832-742-1369



    Primary Logo

    View Full Article Hide Full Article
  4. HOUSTON, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that it will host a live conference call and audio webcast on Friday, August 14, 2020 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2020 and to provide a business overview.

    To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 3237808. A live audio webcast of the call will also be available on the Events section of the…

    HOUSTON, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that it will host a live conference call and audio webcast on Friday, August 14, 2020 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2020 and to provide a business overview.

    To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 3237808. A live audio webcast of the call will also be available on the Events section of the Company's website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event. 

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies.

    For more information, please visit the Company's website at http://www.biopathholdings.com.  

    Contact Information:

    Investors

    Will O'Connor

    Stern Investor Relations

    212-362-1200

     

    Doug Morris

    Investor Relations

    Bio-Path Holdings, Inc.

    832-742-1369

    Primary Logo

    View Full Article Hide Full Article
  5. HOUSTON, May 29, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announces the presentation of a poster highlighting the clinical trial design of its Phase 2 study of BP1001 (prexigebersen) at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually from May 29-31, 2020.

    The poster, titled, "A Phase II Study of BP1001 (liposomal Grb2 antisense oligonucleotide) in Patients with Hematologic Malignancies," was presented virtually by Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center. The…

    HOUSTON, May 29, 2020 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announces the presentation of a poster highlighting the clinical trial design of its Phase 2 study of BP1001 (prexigebersen) at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually from May 29-31, 2020.

    The poster, titled, "A Phase II Study of BP1001 (liposomal Grb2 antisense oligonucleotide) in Patients with Hematologic Malignancies," was presented virtually by Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center. The poster describes the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company's lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

    "This innovative trial design for BP1001 is unique in that it allowed us to adjust our treatment to include newly approved therapies that we believed would be enhanced from combination with our DNAbilize technology. We believe this robust design will provide for the best outcomes for patients and will be the most expeditious route to bringing BP1001 to market. We are delighted to have the design presented and expect that it will enhance visibility for our DNAbilize platform and its versatility among an audience dedicated to bringing new cancer treatments to patients," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

    The Phase 2 clinical trial is a multi-center, open label study with two parallel cohorts of BP1001 in combination with decitabine in untreated AML and high risk MDS patients or refractory/relapsed AML and high risk MDS patients who are ineligible or unwilling to receive intensive induction therapy. The primary objective of the study is to assess whether BP1001 in combination with decitabine provides higher response rates than decitabine alone in AML or high risk MDS patients. In addition, a six-patient safety run-in of BP1001 and decitabine was completed with no dose adjustment required. 

    BP1001 is a neutral liposome incorporated with nuclease-resistant, hydrophobic P-ethoxy antisense oligodeoxynucleotides targeted to Grb2 mRNA. Grb2 is an adaptor protein that links oncogenic tyrosine kinases with downstream kinases, such as ERK and AKT, which are critical to cell proliferation and survival. Preclinical results showed that BP1001 enhanced the inhibitory effects of cytarabine or decitabine against AML cells.

    The poster also describes future development plans for BP1001 in AML. Preclinical results suggest that BP1001 plus venetoclax plus decitabine triple combination could be more efficacious than the BP1001 + decitabine combination against AML cells. Venetoclax will be added to the study, thus exploring three-drug combinations of BP1001, venetoclax and decitabine. There will be three patient cohorts in the study:

    • Untreated AML patients will be treated with BP1001 plus venetoclax plus decitabine.
    • Refractory/relapsed AML patients will be treated with BP1001 plus venetoclax plus decitabine.
    • A third cohort of BP1001 + decitabine will be offered to refractory/relapsed AML patients who are venetoclax resistant or intolerant, or not considered by the investigator as optimal candidates for venetoclax-based therapy.

    About Bio-Path Holdings, Inc.

    Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies.

    For more information, please visit the Company's website at http://www.biopathholdings.com

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, BioPath's ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10- K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact Information:

    Investors

    Will O'Connor
    Stern Investor Relations
    212-362-1200
     

    Doug Morris
    Investor Relations
    Bio-Path Holdings, Inc.
    832-742-1369

    Primary Logo

    View Full Article Hide Full Article
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