GLSI Greenwich LifeSciences Inc.

5.28
-0.21  -4%
Previous Close 5.49
Open 5.48
52 Week Low 3.262
52 Week High 5.75
Market Cap $63,460,790
Shares 12,019,089
Float 3,571,975
Enterprise Value $57,727,216
Volume 33,420
Av. Daily Volume 24,495
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Drug Pipeline

Drug Stage Notes
GP2
Breast cancer
Phase 3
Phase 3
Phase 3 trial to be initiated in 2020.

Latest News

  1. ‒ Phase III clinical trial to be led by Baylor College of Medicine

    ‒ In the Phase IIb clinical trial, led by MD Anderson, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338), with robust immune response, well-tolerated safety profile, and no reported serious adverse events

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the publication of a second abstract at the San Antonio Breast Cancer…

    ‒ Phase III clinical trial to be led by Baylor College of Medicine

    ‒ In the Phase IIb clinical trial, led by MD Anderson, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338), with robust immune response, well-tolerated safety profile, and no reported serious adverse events

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the publication of a second abstract at the San Antonio Breast Cancer Symposium (SABCS), jointly authored by Professor Mothaffar F. Rimawi, the Global Principal Investigator of the GP2 Phase III clinical trial, and the Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, and Professor C. Kent Osborne, Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine. The abstract will be displayed as the Company's second poster on Wednesday, December 9, 2020 in a virtual format with an introductory audio track.

    The abstract highlights the design of the planned Phase III clinical trial. The trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application. The Phase III clinical trial aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery.

    Snehal Patel, CEO of Greenwich LifeSciences, commented, "The participation of Baylor College of Medicine as the Phase III clinical trial lead site further validates the significance of our Phase IIb data. Reducing the recurrence of breast cancer rates to 0% gives us great confidence as we try to reproduce this data in the Phase III clinical trial. We are addressing a potential market of up to $5 billion in a disease that affects 1 in 8 women, who if recur, will likely face metastatic breast cancer."

    "We are very excited to be working with such prominent key opinion leaders. Professor Rimawi's leadership of our Phase III clinical trial will complement the positive Phase IIb clinical trial results with the research and clinical expertise of Baylor College of Medicine. Due to GP2's efficacy and safety profile, GP2 immunotherapy may provide clinicians with an option to reduce the use of other toxic and expensive treatments. We look forward to sharing our Phase IIb clinical trial data and Phase III clinical trial design with breast cancer leaders attending SABCS and to discussing the participation of their clinical sites in our trial," Patel concluded.

    The Phase III clinical trial will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year of treatment with any trastuzumab-based therapy.

    The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years of treatment plus 2 years of follow-up for a total of 5 years following the first year of treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

    The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year of treatment with trastuzumab-based therapy.

    Abstract OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. The full abstract can be viewed here on page 912.

    About SABCS

    The 43rd annual SABCS has grown to be the industry's premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research began collaborations with SABCS in 2007. For more information, please visit the conference website at: https://www.sabcs.org/

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company's website: www.greenwichlifesciences.com

    Forward-Looking Statement Disclaimer

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.

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  2. ‒ Company now preparing to enter a phase III clinical trial

    ‒ Phase IIb clinical trial was a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites) trial led by MD Anderson and completed in 2018

    ‒ No recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p =0.0338)

    ‒ GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously…

    ‒ Company now preparing to enter a phase III clinical trial

    ‒ Phase IIb clinical trial was a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites) trial led by MD Anderson and completed in 2018

    ‒ No recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p =0.0338)

    ‒ GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the publication of an abstract at the San Antonio Breast Cancer Symposium (SABCS). The abstract will be displayed as a poster on Wednesday, December 9, 2020 in a virtual format.

    The study met all of its clinical endpoints for HER2/neu 3+ patients, concluding that the first 6 intradermal injections of GP2+GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery, and this reduction of recurrence rate was maintained over the gold standard of 5 years of follow-up. A pivotal Phase III trial is being initiated to treat HER2/neu 3+ patients in the neoadjuvant setting. GP2 may also be effective when used in parallel to trastuzumab based therapeutics or in combination with trastuzumab based therapeutics in HER2/neu 1-2+ or other HER2/neu expressing cancers.

    Snehal Patel, CEO of Greenwich LifeSciences, commented, "Approximately 50% of recurring patients do not respond to Herceptin or Kadcyla and still recur with metastatic breast cancer and a poor prognosis, where approximately 80-85% of recurring patients do not survive."

    "The publication of this abstract shows that we met all of the endpoints for our Phase IIb clinical trial for HER2/neu 3+ patients, including safety, where no serious adverse events were observed. By substantially reducing the recurrence rate of the non-responders, we are addressing a large unmet need of women. If we are successful in reproducing our Phase IIb clinical trial data in a Phase III clinical trial, we could make a major impact in reducing metastatic breast cancer recurrence in this patient population, potentially saving thousands of lives per year. We are excited to begin our Phase III clinical trial."

    "Based on our analysis of the potential market in our IPO prospectus, GP2 could initially treat 17,000 newly diagnosed patients per year in the US or approximately 50% of the Herceptin adjuvant market of $2-3 billion, and could expand to 2.4x that of the Herceptin market through additional Phase II trials and indications, reaching a potential peak revenue exceeding $5 billion. Not included in these estimates are the 3 million breast cancer survivors in the US of whom 25% are HER2/neu 3+. These survivors could also be candidates for a safe and effective preventative therapy," Patel concluded.

    The abstract highlights the final 5 year follow-up efficacy and demographic data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical trial evaluating the reduction of recurrences. The poster presentation includes the disease-free survival curves for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy, or trastuzumab.

    This 168 patient (ITT: n=180) basket trial across 16 clinical sites explored 96 HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery and subsequently completed the first 6 intradermal injections or placebo, starting GP2 treatment at median 17.1 months after surgery, and 72 HER2/neu 1-2+ patients, who did not receive trastuzumab after surgery and subsequently completed the first 6 intradermal injections or placebo, starting the GP2 treatment at median 10.8 months after surgery.

    Since GP2 is synergistic with trastuzumab, and the HER2/neu 1-2+ patients did not receive trastuzumab, it was prespecified to compare recurrence rates ITT versus per protocol in these 2 distinct, independently reported populations, excluding those patients who did not complete the first 6 intradermal injections. GP2 was shown to be well tolerated with no SAEs and elicited a potent immune response measured by local skin tests and immunological assays, which suggest peak immunity is reached at 6 months upon completion of the first 6 intradermal injections.

    After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 46 HER2/neu 3+ patients treated with GP2+GM-CSF, if the patient completed the first 6 intradermal injections, was 100% versus 89.4% (95% CI:76.2, 95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338). The treated versus placebo HER2/neu 3+ patients were well-matched, where approximately 53% were stage T1, 41% were stages T2-T4, 55% were node positive, 58% were HR positive and received endocrine therapy, 77% received adjuvant radiation, 77% received adjuvant chemotherapy, and 89% received trastuzumab. There was no benefit to GP2 treatment in the HER2/neu 1-2+ patients where trastuzumab was not administered.

    Abstract PS10-23 is entitled: Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2/neu positive women with operable breast cancer. The full abstract can be viewed here on page 654.

    About SABCS

    The 43rd annual SABCS has grown to be the industry's premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research began collaborations with SABCS in 2007. For more information, please visit the conference website at: https://www.sabcs.org/

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company's website: www.greenwichlifesciences.com

    Forward-Looking Statement Disclaimer

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.

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  3. Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the formation of a partnership with Baylor College of Medicine in Houston, Texas to act as the lead clinical site for the Company's upcoming Phase III clinical trial. Professor Mothaffar F. Rimawi has agreed to serve as the Global Principal Investigator of the Phase III clinical trial, and Professor C. Kent Osborne and Professor Rimawi are expected to serve as the first members of the Company's Clinical Advisory Board for the development of GP2 immunotherapy across all indications and HER2…

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the formation of a partnership with Baylor College of Medicine in Houston, Texas to act as the lead clinical site for the Company's upcoming Phase III clinical trial. Professor Mothaffar F. Rimawi has agreed to serve as the Global Principal Investigator of the Phase III clinical trial, and Professor C. Kent Osborne and Professor Rimawi are expected to serve as the first members of the Company's Clinical Advisory Board for the development of GP2 immunotherapy across all indications and HER2 expressing cancers.

    Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are pleased to have entered into this collaboration with such prominent key opinion leaders who are truly committed to evaluating the potential of GP2 immunotherapy. Due to GP2's safety profile, GP2 immunotherapy may provide clinicians with an option to deescalate treatment of patients by reducing the use of other, more toxic and expensive standard of care treatments. Both Professors Rimawi and Osborne have already introduced us to other breast cancer clinical sites and clinical leaders who have provided input into the design of the upcoming Phase III trial and who have expressed an interest in participating in the Phase III trial as high enrollment sites. In addition, we have also been jointly exploring the addition of both US and European breast cancer cooperative groups to more rapidly expand the clinical team."

    Professor Rimawi added, "We are excited to jointly evaluate the potential of GP2 immunotherapy. We believe that our patients will seek to participate in the upcoming trial as the GP2 Phase IIb clinical trial data suggests that GP2 could be both safe and effective and could be easily administered during standard of care follow-up visits. Our patients are seeking safe preventative treatments that allow them to transition away from the trauma of surgery, trastuzumab-based therapies, other HER2 targeted therapies, chemotherapy, and radiation as they seek to return to normal and healthy lives."

    Professor Osborne commented, "Bringing new alternatives to chemotherapy and improving quality of life for patients undergoing treatment for breast cancer are primary focuses of the Breast Cancer Program. GP2 immunotherapy may represent one such opportunity, and we look forward to collaborating with Greenwich LifeSciences and supporting the planned clinical trial with the resources of both the Dan L Duncan Comprehensive Cancer Center and the Baylor College of Medicine."

    Professor Mothaffar F. Rimawi is board certified in internal medicine, hematology and medical oncology, and serves as both Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center.

    Professor C. Kent Osborne is board certified in internal medicine, hematology and medical oncology, and serves as both the Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center. Professor Osborne is also Professor of Medicine and Molecular and Cellular Biology at Baylor College of Medicine.

    About Dan L Duncan Comprehensive Cancer Center

    The Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine has grown and matured over the 13 years since its original designation as a Cancer Center by the National Cancer Institute, which was followed by an NCI Comprehensive Cancer Center designation in 2015. The clinical operations have expanded with new faculty and programs, and the center moved into new clinical space on the McNair campus in January 2019. The research portfolio has grown dramatically to more than $180 million in annual cancer relevant research funding today from less than $100 million in 2007. These amazing accomplishments were made possible by the transformational gift in 2006 from Dan L Duncan and his family.

    Baylor College of Medicine

    Baylor College of Medicine is a leading health sciences university that creates knowledge and applies science and discoveries to further education, healthcare and community service locally and globally. The College was founded in the early 1900s, and in 1943, the MD Anderson Foundation invited Baylor University College of Medicine to join the newly formed Texas Medical Center in Houston, Texas. Four years later, the College moved into its present site in The Roy and Lillie Cullen Building, the first building completed in the new Texas Medical Center. The College's rise in prominence began in the 1950s when Dr. Michael E. DeBakey's innovative surgical techniques garnered international attention. In 1969, the College separated from Baylor University to become an independent institution.

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company's website: www.greenwichlifesciences.com

    Forward-Looking Statement Disclaimer

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.

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  4. Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that it was selected to present at the 2020 Texas Life Science Forum conference to be held virtually from November 10-12, 2020.

    Snehal Patel, CEO of Greenwich LifeSciences, will present and will be available to participate in one-on-one meetings with members of the investor community who are registered to attend the conference. The presentation will be held between approximately 12:00-12:50 pm EST on November 10, 2020, and will highlight the Company's GP2 program and its plans to commence…

    Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that it was selected to present at the 2020 Texas Life Science Forum conference to be held virtually from November 10-12, 2020.

    Snehal Patel, CEO of Greenwich LifeSciences, will present and will be available to participate in one-on-one meetings with members of the investor community who are registered to attend the conference. The presentation will be held between approximately 12:00-12:50 pm EST on November 10, 2020, and will highlight the Company's GP2 program and its plans to commence a Phase III clinical trial. The presentation will be followed by a question and answer session from a 3 member panel of investors. The Company will also participate in a showcase event between approximately 4:30-5:00 pm EST on the same day where conference attendees can meet the company. All events will be in an online format. The corporate presentation is currently available on the investor section of the Company's website at: https://investor.greenwichlifesciences.com/

    About the Texas Life Science Forum

    The Texas Life Science Forum is the premier life science event in Texas that brings together members from industry, emerging life science companies, academia and investors. The 2020 event will be virtual and is hosted by Rice Alliance for Technology and Entrepreneurship and BioHouston. The conference will span 3 days, and will include 35+ hand-picked promising life science companies pitching to investors, investor meetings, panel sessions, and the TLSF Educational Symposium. For more information, please visit the conference website at: http://txlifescienceforum.org/

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company's website: www.greenwichlifesciences.com

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