Greenwich LifeSciences Expands Clinical Trial with New Partners

Greenwich LifeSciences Expands Clinical Trial with New Partners

Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, has announced exciting news about its ongoing Phase III clinical trial, FLAMINGO-01. This trial is particularly focused on GLSI-100, an innovative immunotherapy designed to prevent recurrences in breast cancer patients. Recently, the company took a significant step by initiating new clinical sites across the United States, marking a pivotal expansion of their research efforts.

New Clinical Sites Added

In a remarkable development, both Harvard University and Johns Hopkins University will now serve as participating sites for the FLAMINGO-01 trial in the United States. This will enhance the trial's reach and impact, as these institutions are home to some of the most renowned medical experts in the field. Principal investigators Dr. Laura Spring from Harvard and Dr. Cesar Santa-Maria from Johns Hopkins have been appointed to the trial's Steering Committee, ensuring that their expertise and leadership will guide the trial's success.

Meet the Steering Committee Experts

The Steering Committee has brought together an impressive lineup of experts from some of the most prestigious medical institutions and cancer networks in the world. Highlights of this knowledgeable group include:

• Dr. Mothaffar F. Rimawi – A professor at Baylor College of Medicine, leading the institution’s Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center.
• Dr. Francois-Clement Bidard – Head of the Breast Cancer Group at Institut Curie and a professor of medical oncology at UVSQ/Paris Saclay University.
• Dr. William J. Gradishar – Professor of Medicine at Northwestern University and Chief of Hematology and Oncology.
• Dr. Sibylle Loibl – Chair of the German Breast Group and professor at Goethe University Frankfurt.
• Dr. Miguel Martin – An influential figure in Spain, serving as a professor and head of the Medical Oncology Service at Gregorio Marañón General University Hospital.
• Dr. Joyce A. O’Shaughnessy – Celebrated as the Chair in Breast Cancer at Baylor University Medical Center.
• Dr. Hope S. Rugo – An authoritative voice in breast oncology at the University of California, San Francisco.
• Dr. Cesar A. Santa-Maria – A key player in breast immunotherapy, directing clinical trials at Johns Hopkins.
• Dr. Laura M. Spring – A committed physician and clinical researcher focused on breast cancer at Harvard Medical School.

Dr. Spring's Contributions and Insights

Dr. Spring is notable for her clinical and translational research aimed at improving therapy outcomes for breast cancer patients. With a strong background in targeted therapies, she has made significant strides in developing biomarker strategies. She expressed her enthusiasm about offering the FLAMINGO-01 trial at Massachusetts General Hospital, highlighting the strong interest from both physicians and patients in vaccine strategies to mitigate the risk of cancer recurrence.

Dr. Santa-Maria's Perspective

Similarly, Dr. Santa-Maria boasts a profound commitment to breast cancer research and the development of immunotherapies. As he prepares to initiate the FLAMINGO-01 trial at Johns Hopkins, he shared his excitement about providing high-risk patients with novel vaccine approaches. His extensive experience with breast cancer immunotherapy positions him to play a vital role in the trial's success.

Objectives of FLAMINGO-01

FLAMINGO-01 (NCT05232916) aims to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) specifically for HER2 positive breast cancer patients. This trial targets those who have experienced residual disease or have a high-risk pathology result following surgery and have undergone standard HER2-targeted therapies. Conducted by Baylor College of Medicine, the trial is set to expand not only in the U.S. but also into Europe, with plans to open up to 150 global sites.

Approximately 500 eligible patients will be randomized to receive either GLSI-100 or a placebo, with additional treatment for up to 250 patients of different HLA types in a third arm. This robust design aims to assess the trial's efficacy effectively by detecting significant improvements in invasive breast cancer-free survival rates.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is focused on pioneering treatments aimed at preventing breast cancer recurrences. The company's lead product, GP2, is a unique immunotherapy that targets breast cancer and has demonstrated promising results in early trials. Additionally, the company's ambition to explore global studies positions it to make impactful contributions to breast cancer treatment and patient care.

Frequently Asked Questions

What is the FLAMINGO-01 trial about?

FLAMINGO-01 is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients.

Who are the principal investigators in FLAMINGO-01?

Dr. Laura Spring from Harvard and Dr. Cesar Santa-Maria from Johns Hopkins are key principal investigators in the trial.

What does GLSI-100 aim to achieve?

GLSI-100 aims to prevent recurrences in breast cancer patients who have received standard treatment.

How many patients are expected to participate in the trial?

Approximately 500 patients will be randomized in the study, with plans to treat additional patients of various HLA types.

Where can I find more information about Greenwich LifeSciences?

For more information, please visit the company’s website, which provides resources about their ongoing studies and developments.

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