Greenwich LifeSciences, Inc. - GLSI STOCK NEWS

Greenwich LifeSciences (GLSI) announced key results from two Phase IIb clinical trials presented at the AACR Annual Meeting 2022. The trials evaluated GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. Abstract CT166 highlighted that GLSI-100 elicited a robust immune response in HER2+ patients, achieving a 100% 5-year disease-free survival (DFS) rate for treated patients compared to 89.4% for controls (p = 0.0338). Abstract CT161 indicated that a positive GP2 immune response correlates with increased recurrence risk, offering predictive potential for patient outcomes.

Greenwich LifeSciences announced the registration of its Phase III clinical trial, Flamingo-01, on clinicaltrials.gov. This trial, testing GLSI-100, aims to prevent breast cancer recurrences in patients post-surgery. The trial will involve approximately 600 patients and has the potential for significant patent extensions if successful. The company will present three clinical trial posters at the upcoming AACR Annual Meeting 2022 from April 8-13, providing updates on trial progress and further recruitment of clinical sites.

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced that CEO Snehal Patel will present at the 2022 BIO CEO & Investor Conference on February 14, 2022. The conference, from February 14-17, focuses on biotech networking and investment opportunities. Greenwich is developing GLSI-100, an immunotherapy to prevent breast cancer recurrences, currently in the FLAMINGO-01 Phase III clinical trial targeting HER2-positive patients. The trial aims to assess effectiveness based on interim analyses of patient outcomes.

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.