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Greenwich LifeSciences, Inc. (NASDAQ: GLSI) is a clinical-stage biopharmaceutical company dedicated to the development of groundbreaking immunotherapies aimed at preventing breast cancer recurrences. The company's flagship product, GP2, is an immunotherapy designed to stimulate the body's immune system to target and eliminate HER2/neu-expressing cancer cells, particularly in patients who have already undergone surgery for breast cancer.
GP2 leverages the HER2/neu transmembrane peptide to elicit a targeted immune response, providing a promising approach to cancer treatment. Another significant component of their pipeline is the GM-CSF Immunoadjuvant, which has shown potential in enhancing monocyte and neutrophil cytotoxicity against melanoma tumor cells, as well as boosting activity-dependent cellular cytotoxicity against targets coated with anti-ganglioside antibodies.
The company’s ongoing clinical trials are a testament to its commitment to innovation and excellence in cancer treatment. These trials are being conducted in collaboration with a steering committee comprising esteemed members from various medical institutions, ensuring rigorous oversight and adherence to the highest standards of clinical research.
Greenwich LifeSciences places a strong emphasis on advancing cancer immunotherapy to selectively stimulate an individual's immune system to attack cancer cells, thereby inhibiting the spread of the disease. Their work not only focuses on breast cancer but extends to other cancer types, showcasing a broad potential for impact in oncology.
With a robust pipeline, strategic partnerships, and a clear focus on unmet medical needs, Greenwich LifeSciences is poised to be a leader in the biopharmaceutical industry. Investors and stakeholders can stay updated on the latest developments and company performance through regular news updates and reports.
Greenwich LifeSciences announced the publication of a second poster for its GP2 Phase III clinical trial targeting breast cancer recurrence at the San Antonio Breast Cancer Symposium. The trial seeks to replicate previous results showing no recurrences in HER2/neu 3+ patients after treatment with GP2 + GM-CSF. The Phase III trial will include interim analysis for FDA marketing approval and involve 11 injections over three years. CEO Snehal Patel expressed confidence in the collaboration with Baylor College of Medicine to achieve these goals.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) presented a poster on the final efficacy analysis of its GP2 Phase IIb clinical trial at the San Antonio Breast Cancer Symposium. The trial demonstrated a 0% recurrence rate in HER2/neu 3+ patients after 5 years, validating GP2's potential as a treatment. CEO Snehal Patel indicated plans for a Phase III trial, addressing a significant unmet need in breast cancer treatment, with a potential market exceeding $5 billion. The study included 168 patients and indicated that GP2 could also be effective for HER2/neu 1-2+ populations.
Greenwich LifeSciences (Nasdaq: GLSI) has secured a contract for the final formulation and filling of its GP2 immunotherapy, aimed at preventing breast cancer recurrences. The contract will enable the storage and distribution of GP2 to clinical sites, with activities starting in 2021. The company has also leased a facility in Stafford, Texas, to support its manufacturing and research initiatives. CEO Snehal Patel expressed optimism about these developments as crucial steps towards commencing the Phase III clinical trial following promising Phase IIb results, showing no recurrences after a median follow-up of five years.
Greenwich LifeSciences (Nasdaq: GLSI) announced it will present at the Annual LD Micro Main Event virtually on December 14-15, 2020. CEO Snehal Patel will present at 1:20 pm EST on December 15, focusing on GP2, an immunotherapy aimed at preventing breast cancer recurrences post-surgery. Recently published GP2 data and plans for a Phase III clinical trial will be highlighted. For more details, visit the investor section of the Company's website.
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.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced the publication of an abstract at the San Antonio Breast Cancer Symposium, highlighting positive results from its Phase IIb clinical trial for GP2 immunotherapy. This therapy demonstrated a 0% recurrence rate in HER2/neu 3+ patients over five years, surpassing the 89.4% rate of placebo patients. A pivotal Phase III trial will follow. With a potential market for GP2 estimated at $5 billion, the therapy aims to address a significant gap for patients unresponsive to current treatments.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has been selected to present at the virtual Texas Life Science Forum from November 10-12, 2020. CEO Snehal Patel will present on November 10, from 12:00-12:50 pm EST, discussing the GP2 immunotherapy program aimed at preventing breast cancer recurrences. The event also includes one-on-one meetings and a showcase for investors, emphasizing the company's Phase III clinical trial plans. The Texas Life Science Forum, hosted by Rice Alliance and BioHouston, features over 35 life science companies.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has announced its selection to present at the 2020 BIO Investor Forum and participate in the BIO-Europe partnering conference. CEO Snehal Patel will discuss the GP2 program, aimed at preventing breast cancer recurrences, and plans for a Phase III clinical trial. The investor presentation will be available on the company's website. The BIO-Europe event aims to connect with pharmaceutical companies for potential licensing of therapeutics. In clinical trials, GP2 showed no recurrences in HER2/neu 3+ patients after five years.
Greenwich LifeSciences (Nasdaq: GLSI) has completed the manufacturing of the GP2 active ingredient for its upcoming Phase III clinical trial aimed at preventing breast cancer recurrences. The drug has met all specifications in compliance with current Good Manufacturing Practice (cGMP) and will soon be reformulated and filled into vials. The company also recently completed its IPO, raising substantial funds that will support this critical trial. GP2, already tested in several trials, showed no recurrences in previous studies of HER2/neu positive patients after treatment.
Greenwich LifeSciences announced the closing of its initial public offering, selling 1,260,870 shares at $5.75 each, totaling $7,250,002 in gross proceeds. The offering includes a 45-day option for the underwriter to purchase an additional 189,130 shares. Trading commenced on Nasdaq under the symbol 'GLSI' on September 25, 2020. The company focuses on developing GP2, an immunotherapy aimed at preventing breast cancer recurrence in patients post-surgery. The Phase IIb trial results showed no recurrences after five years in the treated group, highlighting positive clinical outcomes.
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