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STAFFORD, Texas--( Business organization WIRE )--Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical visitor focused on the evolution of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the expansion of Dr. F. Joseph Daugherty's role to include the critical responsibility of Medical Monitor of the Phase III clinical trial and a long-term agreement to serve as Chief Medical Officeholder.
Dr. Daugherty commented, "I expect forward to supporting the GLSI-100 clinical trials as Medical Monitor. While GP2 has been shown to be both effective and safe in the Phase IIb trial, we volition maintain our vigilance in the larger Phase III trial. The balmy local and systemic reactions observed in the Phase IIb trial have served to further validate the immune response and machinery of action of GP2, thus requiring the balancing of dosing to ensure that local and systemic reactions are tolerable and prophylactic, yet still sufficiently robust enough to lead to the prevention of metastatic chest cancer recurrence."
CEO Snehal Patel added, "Nosotros are very excited that Dr. Daugherty is expanding his role with a very significant delivery to serve every bit medical monitor of our upcoming and future clinical trials equally we seek to expand GP2's potential to all HER2 positive chest cancer patients and to explore HER2 low breast cancer and other HER2 expressing cancers. While we accept non seen any serious adverse events in the 138 patients we have treated to date across iv clinical trials owing to GP2 immunotherapy, Dr. Daugherty's responsibility to oversee the safety of our Phase III trial will be a key component of our regulatory strategy in this potential unmarried registration trial."
Dr. Daugherty has over 40 years of experience in managing and overseeing biotechnology and biomedical projects. He served first as President and recently every bit Chief Executive Officeholder, Chief Medical Officeholder, and the Chairman of the board of directors of Eleos, Inc., a clinical-stage, individual biotech company focused on anti-sense engineering in hematologic cancers. In addition to being an officer and director, Dr. Daugherty has served in various other capacities, including as a management consultant to over 20 public and private biomedical companies including Dupont, Inc, and every bit President of ConAgra'south biotech division. He received a BA in Biology from Washington University, a MD from the University of Nebraska, and a MS in Industrial Administration from Carnegie Mellon University.
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will exist called GLSI-100. The Phase III trial is comprised of ii blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and one open label arm of upwards to 100 patients for all other HLA types. An interim assay has been designed to notice a hazard ratio of 0.3 in IDFS, where 28 events volition exist required. An interim analysis for superiority and futility will be conducted when at to the lowest degree half of those events, fourteen, have occurred. This sample size provides 80% power if the almanac rate of events in placebo-treated subjects is 2.four% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier volition be published shortly. For future updates almost FLAMINGO-01 please visit the Company's clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.
About Breast Cancer and HER2/neu Positivity
One in eight U.Southward. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor two) protein is a jail cell surface receptor protein that is expressed in a variety of mutual cancers, including in 75% of breast cancers at low (ane+), intermediate (2+), and high (3+ or over-expressor) levels.
Well-nigh 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 poly peptide. In a randomized, single-blinded, placebo-controlled, multi-centre (16 sites led by Medico Anderson Cancer Center) Stage IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting subsequently median five years of follow-up, if the patient received the 6 primary intradermal injections over the first six months (p = 0.0338). Of the 138 patients that take been treated with GLSI-100 to appointment over 4 clinical trials, treatment was well tolerated and no serious adverse events were observed related to the immunotherapy. Greenwich LifeSciences is planning to commence a Phase 3 clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, delight visit the Visitor's website at www.greenwichlifesciences.com and follow the Visitor's Twitter at https://twitter.com/GreenwichLS.
About GP2 Immunotherapy Immune Response
As previously reported, GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2'due south mechanism of action. Statistically meaning summit immunity was reached after vi months of GP2 treatment, as measured in both the Dimer Binding Analysis and the DTH skin test. HER2/neu 3+ population immune response was like to the HER2/neu i-2+ population immune response, suggesting the potential to treat the HER2/neu 1-ii+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents. The wide based immune response suggests the potential for GP2 to treat other HER2/neu one-3+ expressing cancers. For more information on GP2 allowed response and clinical data, delight visit the Company's clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.
Forward-Looking Statement Disclaimer
Statements in this press release comprise "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," "approximate," "await," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other like expressions, although non all forward-looking statements comprise these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s electric current expectations and are discipline to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or unsaid by such forward-looking statements. Further, certain forward-looking statements are based on assumptions every bit to future events that may not prove to be authentic. These and other risks and uncertainties are described more than fully in the section titled "Risk Factors" in the last prospectus related to the public offering filed with the SEC. Forrard-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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