Greenwich LifeSciences Announces Second Publication and Second Poster Presentation of Phase III Clinical Trial of Potential Breakthrough Technology for Recurring Breast Cancer
Greenwich LifeSciences (Nasdaq: GLSI) announced a second abstract publication at the San Antonio Breast Cancer Symposium (SABCS) regarding the Phase III clinical trial for GP2, an immunotherapy aimed at preventing breast cancer recurrence. The trial seeks FDA conditional marketing approval following an interim analysis. Phase IIb results showed a 0% recurrence rate in HER2/neu 3+ patients post-surgery. The trial will involve 11 injections over three years and targets a potential $5 billion market. CEO Patel emphasized the collaboration with Baylor College of Medicine and the significance of the Phase IIb findings.
- Phase IIb study showed 0% recurrence rate in HER2/neu 3+ patients after GP2 treatment.
- Potential market opportunity of $5 billion for breast cancer treatment.
- Collaboration with Baylor College of Medicine enhances credibility and expertise.
- Phase III trial design aims for FDA conditional marketing approval, indicating confidence in trial outcomes.
- None.
STAFFORD, Texas--(BUSINESS WIRE)--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
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
“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
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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