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Greenwich LifeSciences Provides Updates on Upcoming Phase III Clinical Trial & ASCO Meeting

  • FDA review of manufacturing plans and pharmacy procedures associated with a recently placed clinical hold on the FLAMINGO-01 phase III clinical trial is underway with formal feedback from the FDA expected shortly. Greenwich is prepared to address FDA manufacturing and pharmacy procedure hold issues so that FLAMINGO-01 can commence as soon as possible.
  • Negotiations of clinical trial contracts and budgets for the first 3 large hospital sites and the largest oncology network in the US are completed and in the execution phase, paving the way for site initiation visits and subsequent site activation. Following site activation, patients will be screened, tested for HLA type, randomized and enrolled into any of 3 arms, and treated. Patients who are interested in participating in the trial will be able to contact the Company by email at flamingo-01@greenwichlifesciences.com and will be able to keep up to date with the progress of the trial on clinicaltrials.gov with identifier NCT05232916 (view here).
  • Company management will present 2 posters in person and will meet with clinical sites and networks participating in the upcoming FLAMINGO-01 phase III clinical trial at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2022, which will be held from June 3-7, 2022 in Chicago, Illinois

Greenwich LifeSciences, Inc. (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 the following:

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GLSI Provides Updates on Upcoming Phase III Clinical Trial & ASCO Meeting

We have completed the manufacturing of GP2, released 3 clinical lots, and started the stability testing program for these lots. Previously, the FDA informally asked us to allow them to review an updated chemistry and manufacturing section on drug product before initiating the Phase III trial as our manufacturing information for the final drug product was incomplete and the lots were being tested for the first time. Subsequently, we received a formal clinical hold letter. Greenwich has provided a response and is working with the FDA to resolve all outstanding issues. All hold issues are associated with manufacturing and pharmacy procedures.

We continue to work toward study initiation. We are scheduling site initiation visits to train clinicians, nurses, coordinators, and pharmacists to activate and open clinical sites. We, along with our CRO, continue to actively recruit and prepare sites for site initiation.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “We continue to make progress towards opening up our first sites. We just completed our first Data Safety Management Board (DSMB) meeting and are currently scheduling our initial Steering Committee Meeting with the lead clinicians of FLAMINGO-01. Our electronic data capture and inventory management systems are anticipated to go live in June. We are working to address all FDA issues rapidly so that the study can be initiated shortly.”

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Three abstracts and two posters were accepted for presentation at the upcoming AACR Annual Meeting 2022. The titles of the abstracts are as follows:

  • Abstract Number: LBA550; Poster Number: 322; Abstract Title: Evaluation of booster injections in maintaining peak immunity in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus GM-CSF alone after adjuvant trastuzumab in HER2 positive women with breast cancer.
  • Abstract Number: e12519; Abstract Title: Baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer.
  • Abstract Number: TPS1110; Poster Number: 485b; Abstract Title: A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 (Co-authored with Baylor College of Medicine)

CEO Snehal Patel commented, “These abstracts and posters highlight the first steps to optimizing the use of GLSI-100. We are planning to study the peak immunity of GP2 and how to assess when to administer booster injections. The current methodology is to deliver 6 primary injections over the first 6 months and 5 booster injections 6 months apart, thus totaling 11 injections over 3 years. However, in the future, we envision using immune response and T-cell profiles to determine when boosters may be needed. This may allow GLSI-100 to protect breast cancer survivors over longer periods of time against recurring metastatic breast cancer. In addition, approximately 20% of patients in the Phase IIb trial had a GP2 immune response before being treated with GP2, possibly due to a potential impending recurrence. We found that some patients with baseline immune response to GP2 tended to recur at faster rates. We are planning to study this observation in the Phase III trial, which could lead us to being able to use GP2 immune response as an independent prognosticator for impending recurrence. This would allow doctors to detect recurrences sooner than current standard of care and to thus start aggressive treatments sooner with potentially better outcomes.”

Mr. Patel further added, “This will be the first ASCO meeting in person since 2019, attended by oncologists from around the world. Greenwich is in discussions with 2 of the largest oncology networks in Europe for participation in FLAMINGO-01, and we look forward to expanding our outreach to potential international sites at ASCO. In the US, we anticipate that the largest oncology network will provide one of the first sites to treat patients and that a second oncology network in the US may participate along side. We believe that the participation of clinical trial networks focused on cancer treatment will help to increase the enrollment rate in FLAMINGO-01 and expand the geographic footprint to allow more patients to participate.

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