1. Greenwich LifeSciences completed enrollment in FLAMINGO-01's non-HLA-A*02 arm. 2. The trial targets 500 HLA-A*02 patients, with 250 non-HLA-A*02 populations. 3. GLSI-100 shows promising trends in immune response and safety profile. 4. CEO emphasizes potential for market of 88,000 new patients annually. 5. Regulatory approvals are being sought for expanding patient enrollment.
FAQ
Why Bullish?
The positive progress in clinical trials often leads to increased investor confidence, similar to historical cases where companies exhibiting strong trial results saw a corresponding rise in stock price.
How important is it?
The article directly discusses GLSI's clinical trial progress, which is critical for future stock performance; investors often react positively to trial milestones and enrollment news.
Why Long Term?
If clinical trials prove successful, GLSI could significantly scale its market presence over the next few years, paralleling other biopharmaceutical successes that experienced sustained stock growth post-approval.
Greenwich LifeSciences Completes Enrollment for FLAMINGO-01 Study
STAFFORD, Texas, Dec. 8, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, has announced the successful completion of enrollment in the open label non-HLA-A*02 arm of its Phase III clinical trial known as FLAMINGO-01. This trial is focused on evaluating GLSI-100, an innovative immunotherapy aimed at preventing recurrences of breast cancer.
Trial Design and Enrollment Details
The FLAMINGO-01 trial includes double-blinded arms where approximately 500 HLA-A*02 patients will be randomized to receive either GLSI-100 or a placebo. Additionally, up to 250 patients with other HLA types (non-HLA-A*02) were enrolled in the open label arm. The non-HLA-A*02 group—constituting about 55% of the patient population—lacks the HLA-A*02 allele from both parents.
The successful enrollment in the open label arm reflects a high screening and enrollment rate, marking a significant milestone for the trial.
Regulatory Approvals and Future Steps
Greenwich LifeSciences has paused further enrollment in the non-HLA-A*02 arm earlier this year but is actively seeking regulatory approval to resume randomized enrollment for new non-HLA-A*02 patients with a control arm. The company continues to screen a substantial number of these patients, allowing for rapid enrollment once regulatory compliance is achieved.
Promising Early Observations
Earlier this year, Greenwich LifeSciences reported encouraging findings indicating that the immune response in non-HLA-A*02 patients trends positively, similar to that seen in HLA-A*02 arms of FLAMINGO-01, as well as in a prior Phase IIb study where breast cancer recurrences were reduced by up to 80%. CEO Snehal Patel emphasized, "It is important to note that all 250 patients in the non-HLA-A*02 arm received GLSI-100. This exposure is significantly higher than the approximately 50 patients treated in the Phase IIb trial."
Market Potential and Patent Strategies
Greenwich LifeSciences believes the novel application of GLSI-100 in the non-HLA-A*02 patient demographic could significantly increase the number of eligible patients in the U.S. and Europe, estimating about 88,000 new patients per year and a market potential in the range of $8-10 billion annually.
Furthermore, Mr. Patel noted that the company's patent claims for this innovation are independently owned, providing opportunities for strengthening its intellectual property portfolio, potentially extending protections for GLSI-100 beyond 2040.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is structured to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response following neoadjuvant and postoperative adjuvant trastuzumab-based treatments. Currently, the trial is being conducted by Baylor College of Medicine, with plans to expand to 150 clinical sites globally.
Breast Cancer Statistics
In the U.S., approximately one in eight women will face invasive breast cancer during their lifetime, translating to around 300,000 new patients each year and approximately 4 million survivors currently. The HER2 (human epidermal growth factor receptor 2) protein is a critical biomarker present in about 75% of breast cancers.
About Greenwich LifeSciences
Greenwich LifeSciences, Inc. specializes in developing GP2, an immunotherapeutic approach to prevent recurrences of breast cancer among patients with a surgical history. For more information about the Company and FLAMINGO-01, visit www.greenwichlifesciences.com.