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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 (GLSI) has made substantial progress in its Phase III clinical trial, FLAMINGO-01, aimed at preventing breast cancer recurrences. Key developments include the completion of critical study initiation steps, such as securing a Contract Research Organization and obtaining Central Institutional Review Board approval. A total of 25 clinical sites are currently being established, and manufacturing of the GP2 active ingredient has been finalized. The trial will involve approximately 600 patients and aims to assess the efficacy of GP2 immunotherapy in preventing cancer recurrence.
Greenwich LifeSciences (NASDAQ: GLSI) has announced a stock repurchase program authorized by its Board of Directors, allowing for the repurchase of up to $10 million of its common stock. This program aims to enhance shareholder value and will be funded through the company’s working capital, valid until March 31, 2023. Additionally, the lock-up period for shares held by directors and officers has been extended to March 24, 2023. The company is focusing on its Phase III clinical trial for GLSI-100, aimed at preventing breast cancer recurrences.
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.
Greenwich LifeSciences (GLSI) reported promising results from the GP2 Phase IIb clinical trial at the San Antonio Breast Cancer Symposium 2021. The study observed that 22.8% of 145 patients had a positive immune response to GP2 prior to treatment, indicating potential for predicting breast cancer recurrence. While patients with a positive immune response recurred faster, the 5-year disease-free survival rate was 100% for HER2 positive patients treated with GP2. The company plans further studies to confirm findings and explore GP2 as a CAR-T therapy candidate.
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announces participation in interviews and conferences centered around their immunotherapy, GLSI-100, aimed at preventing breast cancer recurrences. At the 2021 San Antonio Breast Cancer Symposium, management will present two posters. A key focus is the Phase IIb trial results indicating no recurrences over 5 years for treated HER2 positive patients. Upcoming virtual conferences include H.C. Wainwright BioConnect Conference and Biotech Showcase. The FLAMINGO-01 Phase III trial aims to enroll approximately 600 patients.
Greenwich LifeSciences (Nasdaq: GLSI) has appointed Dr. F. Joseph Daugherty as Medical Monitor for its upcoming Phase III clinical trial, named FLAMINGO-01, which aims to assess the immunotherapy GP2 for preventing breast cancer recurrences. The trial will involve approximately 600 patients with a primary focus on safety and efficacy, building on the success of a previous Phase IIb trial where no recurrences were observed in the HER2/neu 3+ population. The company emphasizes its commitment to rigorous safety oversight through Dr. Daugherty's extensive experience in oncology clinical trials.
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announced the commencement of commercial line filling for its immunotherapy GP2 aimed at preventing breast cancer recurrences. This milestone is part of preparations for filing a Biologics License Application (BLA) after generating three commercial lots, aiming to treat approximately 22,000 patients. The Phase III clinical trial, named FLAMINGO-01, will begin shortly, with a focus on patients with HLA-A*02. The company has engaged various partners for production and clinical support, enhancing the potential success of GP2 in the market.
Greenwich LifeSciences, Inc. (GLSI) will feature CEO Snehal Patel in an exclusive interview on Bloomberg TV's The RedChip Money Report on November 20, at 7 pm ET. The interview will cover Phase IIb clinical trial outcomes for GLSI-100, showing no metastatic breast cancer recurrences over five years. Upcoming clinical trials FLAMINGO-01 will involve 500 patients, aiming for significant event detection. The company is preparing for future data publications and highlights the impact of joining the Russell 2000.
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) has announced that CEO Snehal Patel will participate in Jefferies’ Annual London Healthcare Conference from November 16-19, 2021. This prestigious event is Europe's largest healthcare-focused conference, featuring top companies in the pharmaceutical and biotechnology sectors. The company is advancing its Phase III clinical trial, FLAMINGO-01, for GP2, an immunotherapy aimed at preventing breast cancer recurrence, with the trial expected to involve approximately 600 patients.
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announced the acceptance of two abstracts and posters for presentation at the San Antonio Breast Cancer Symposium (SABCS) scheduled for December 7-10, 2021. The posters will highlight data from their ongoing Phase IIb clinical trial of GLSI-100, their immunotherapy aimed at preventing breast cancer recurrence. CEO Snehal Patel emphasized the significance of this data, citing a 100% disease-free survival rate over five years. The Phase III trial, FLAMINGO-01, is set to commence, targeting approximately 500 patients.
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