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Greenwich LifeSciences CEO Participates in TD Ameritrade Interview to Discuss 2021 SABCS Poster
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Greenwich LifeSciences, Inc. (GLSI) announced that CEO Snehal Patel discussed the Phase IIb clinical trial of GLSI-100 in a recent TD Ameritrade interview. The trial revealed that 22.8% of 145 patients had an immune response to GP2 before treatment, indicating potential early recurrence of breast cancer. The forthcoming Phase III trial, named FLAMINGO-01, aims to explore this immunotherapy further. If successful, it could lead to significant advancements in breast cancer treatment. The trial is currently in the registration phase.
Positive
Phase IIb trial data shows 22.8% immune response to GP2 before treatment, suggesting early detection of recurrences.
No serious adverse events reported in 138 patients treated with GLSI-100, indicating good treatment tolerability.
Upcoming Phase III trial (FLAMINGO-01) aims to expand understanding of GP2 immunotherapy.
Negative
While the immune response indicates potential recurrences, further confirmation is needed from the Phase III trial.
The Phase IIb trial sample size may limit the reliability of observed patterns regarding immune response and recurrence.
STAFFORD, Texas--(BUSINESS WIRE)--
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that CEO Snehal Patel participated in a TD Ameritrade interview to discuss the Phase IIb poster presented at the 2021 San Antonio Breast Cancer Symposium on December 9, 2021.
Mr. Patel appeared for a second time as a featured guest in a live interview on TD Ameritrade Network's The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.
In the interview, Mr. Patel discussed how the new Phase IIb clinical trial findings could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect metastatic breast cancer recurrences earlier. The newly published Phase IIb clinical trial data shows that 22.8% of 145 patients had an immune response to GP2 prior to any treatment with GP2. Typically, no response to GP2 would be expected until after treatment with GP2. However, an immune response was seen in these patients before any treatment with GP2, suggesting that their cancer was already recurring. The data suggests that patients with an immune response to GP2 prior to treatment recurred twice as fast and approximately 7 to 11 months sooner than those without an immune response prior to treatment did. The number of recurrences was low in the Phase IIb clinical trial, so these observations will be confirmed further in the larger Phase III trial, and the data will be available as early as 2022.
Mr. Patel continued to discuss how in the Phase III clinical trial, T cells will be fully characterized and identified at the DNA level to better understand the initial immune response to GP2. GP2 immunotherapy trains T cells to attack metastatic breast cancer. By identifying the GP2 specific T cells that are attacking the cancer, the most effective T cells could be developed as drug candidates and given directly to patients as a treatment using CAR-T cell technology. Thus the Company could use this new patentable T cell technology for both diagnosis and treatment, expanding the Company’s pipeline beyond just GP2 and further benefiting patients.
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about 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.S. 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 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 GLSI-100 to date 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 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 at www.greenwichlifesciences.com and follow the Company'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’s mechanism of action. Statistically significant peak immunity was reached after 6 months of GP2 treatment, as measured in both the Dimer Binding Assay and the DTH skin test. HER2/neu 3+ population immune response was similar to the HER2/neu 1-2+ population immune response, suggesting the potential to treat the HER2/neu 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents. The broad based immune response suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. For more information on GP2 immune response and clinical data, please visit the Company’s clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.
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, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. 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 SEC. 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.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447)
Cell: (407) 491-4498
Email: dave@redchip.com
Source: Greenwich LifeSciences, Inc.
FAQ
What were the key findings of Greenwich LifeSciences' Phase IIb trial for GLSI-100?
The Phase IIb trial found that 22.8% of 145 patients had an immune response to GP2 before treatment, suggesting potential early detection of breast cancer recurrences.
What is the future plan for GLSI-100 after the recent Phase IIb trial results?
Greenwich LifeSciences plans to conduct a Phase III trial named FLAMINGO-01 to further explore the efficacy of GLSI-100.
What is the expected timeline for results from the Phase III trial FLAMINGO-01?
Data from the Phase III trial is expected to be available as early as 2022.
How many patients are involved in the upcoming FLAMINGO-01 trial?
The FLAMINGO-01 trial will include approximately 500 patients with HLA-A*02 and an additional 100 patients for other HLA types.
What is the primary goal of the FLAMINGO-01 Phase III trial?
The primary goal is to characterize T cells and understand the immune response to GP2, potentially leading to effective treatment options.
