Greenwich LifeSciences Announces Key Share Lock-Up Extension

Greenwich LifeSciences Extends Lock-Up Period for Directors

Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a dynamic clinical-stage biopharmaceutical company, has announced an important update regarding its board of directors and officers. The company has extended the lock-up period for shares owned by these individuals as well as pre-IPO investors until March 31, 2026. This decision comes as part of the company's ongoing commitment to its Phase III clinical trial, FLAMINGO-01, which focuses on the investigational immunotherapy GLSI-100.

Understanding FLAMINGO-01 and GLSI-100

FLAMINGO-01 is not just a clinical trial; it represents hope for many patients dealing with breast cancer. This extensive Phase III trial aims to determine the safety and efficacy of GLSI-100 among patients who have undergone previously suggested treatments but remain at risk for cancer recurrence. The trial targets HER2 positive breast cancer patients with residual disease after surgery.

Currently led by experts at Baylor College of Medicine, the FLAMINGO-01 trial is planned to expand beyond U.S. borders, focusing on Europe, with an impressive aim of establishing up to 150 global clinical sites. The design of the study allows for approximately 500 patients identified as HLA-A*02 to be randomized to receive either GLSI-100 or a placebo, while a third arm will involve treating up to 250 patients of varied HLA types with GLSI-100. By achieving clear insight into the effectiveness of this immunotherapy, the study hopes to define progress made in invasive breast cancer-free survival. The power of the trial is built on significant metrics that ensure the collection of data is robust and able to suggest actionable outcomes.

The Broader Context of Breast Cancer

Breast cancer remains one of the most common cancers affecting women in the U.S., with a staggering statistic suggesting that one in every eight women may be diagnosed within their lifetime. Each year, around 300,000 new cases arise, highlighting the pressing need for effective treatments and preventive therapies. In particular, GLSI-100's exploration is vital given that HER2 positivity occurs in about 75% of breast cancers, underscoring its significance as a target for immunotherapy.

For many women, together with ongoing advancements in technology and research, initiatives like the FLAMINGO-01 trial can not only change individual life trajectories but potentially influence the overall landscape of cancer treatment.

Company Overview

Greenwich LifeSciences is committed to innovating cancer therapies, specifically through the development of GP2, an immunotherapy designed to help prevent breast cancer recurrences. The foundation of this treatment lies in its composition as a transmembrane peptide of the HER2 protein. In line with this mission, Greenwich LifeSciences is dedicated to pushing boundaries, driven by the results expected from its ongoing trials and research endeavors.

For potential participants and those seeking more information about both the company and the trial, interactive resources are available. This includes a direct email contact for inquiries about participation in the FLAMINGO-01 study, ensuring that interested parties can have a transparent dialogue about engagement.

Future Developments

As Greenwich LifeSciences moves forward, the company recognizes the importance of transparency and accessibility in its communications. Shareholders and potential investors will see this lock-up extension as a commitment to conscientious development and planning in line with ongoing research objectives. With the extension until 2026, there is optimism regarding the timelines associated with yielding clinical results that could redefine patient options within oncology.

Frequently Asked Questions

What is the significance of the extended lock-up period?

The extended lock-up period prevents directors, officers, and certain shareholders from selling their shares until March 31, 2026, showcasing their commitment to the company during its trial phase.

What is the focus of the FLAMINGO-01 clinical trial?

The FLAMINGO-01 trial primarily assesses the safety and efficacy of GLSI-100, aimed at preventing breast cancer recurrences in high-risk patients.

How many sites will participate in the FLAMINGO-01 trial?

The trial plans to utilize approximately 150 sites globally as it expands into Europe, enhancing its research capabilities.

What does HER2 positivity mean in the context of breast cancer?

HER2 positivity indicates that a breast cancer tumor has higher levels of the HER2 protein, which is often associated with aggressive disease and is a critical target for specific therapies.

How can I learn more about participating in the FLAMINGO-01 trial?

You can reach out via email to the provided contact for inquiries regarding participation and to explore the trial further.

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