Greenwich LifeSciences Expands Clinical Trials into Romania

Greenwich LifeSciences Expands Clinical Trials into Romania

Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, is making significant strides in the fight against breast cancer with its ongoing Phase III clinical trial named FLAMINGO-01. Recently, the company announced that it has received approval from European regulators to include clinical sites in Romania, marking a crucial expansion in its study of its innovative immunotherapy, GLSI-100, which aims to prevent recurrences of breast cancer.

Approval and Expansion of FLAMINGO-01

The formal approval to expand Flamingo-01 into Romania has allowed the company to add to its growing list of clinical sites, which already includes around 150 approved locations across countries such as Spain, France, Germany, Italy, Poland, and the US. Currently, approximately 123 sites worldwide are actively enrolling patients, providing patients across different nations access to this vital research.

Breast Cancer Statistics and Significance of New Sites

Breast cancer remains a pressing health issue in Romania, accounting for a significant portion of cancer diagnoses among women. Recent data from the European Cancer Information System revealed that there were 12,861 new breast cancer cases diagnosed in Romania in 2022, making it the most prevalent cancer among women in the country. The impact of breast cancer is profound, with the disease being the leading cause of cancer-related deaths among women in Romania, occurring in 3,877 cases just last year.

Collaboration with Leading Experts

Greenwich LifeSciences is collaborating with Dr. Nicoleta Antone, a renowned figure in breast cancer treatment, who leads one of the largest breast cancer centers in Cluj Napoca. Dr. Antone, who serves as the national principal investigator for FLAMINGO-01 in Romania, brings a wealth of knowledge and expertise to the trial. Alongside her colleagues from three additional sites, Dr. Antone's involvement underscores the company's commitment to achieving the best possible outcomes through rigorous clinical research.

CEO Statement on Future Goals

CEO Snehal Patel expressed excitement for this new chapter in the company's journey. He mentioned, "Romania is the first of several additional countries in Europe that we hope to add to Flamingo-01 as we now focus on mid-sized population countries with significant population centers. Our team has conducted multiple visits to these sites in Romania to ensure the study's feasibility and to provide thorough training, and we are inspired by the dedication and facilities we've witnessed. We anticipate screening and enrolling our first Romanian patients in the near future, which is an important step forward for us and the ongoing battle against breast cancer.”

Details on FLAMINGO-01 and GLSI-100

FLAMINGO-01, with its clinical trial identifier NCT05232916, seeks to evaluate the efficacy and safety of GLSI-100, an innovative treatment designed for HER2 positive breast cancer patients. The trial primarily targets patients who have had residual disease after surgery and those at high-risk for disease recurrence. With plans to expand up to 150 clinical sites globally, researchers have structured the trial to include a substantial participant pool for statistical significance. Approximately 500 participants will be randomized to either receive GLSI-100 or a placebo, while an additional group of 250 patients with different HLA types will also receive treatment, enabling researchers to gather comprehensive data on the treatment's effectiveness.

Further Context on Breast Cancer and Treatment

Breast cancer is a leading health concern, affecting one in every eight women in the US and accounting for around 300,000 new diagnoses annually. The HER2 receptor plays a critical role in the pathology of breast cancer. It is found in about 75% of breast cancer cases at various expression levels, indicating a pivotal area of focus for therapies aiming to target cancerous growth without affecting healthy tissue.

About Greenwich LifeSciences

Greenwich LifeSciences is dedicated to developing GP2, an immunotherapy specifically aimed at preventing recurrences of breast cancer in patients post-surgery. As a clinical-stage biopharmaceutical company, it aims to utilize cutting-edge research and rigorous trials, like FLAMINGO-01, to bring innovative solutions to light for the ongoing battle against breast cancer.

Frequently Asked Questions

What is FLAMINGO-01?

FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 aimed at preventing breast cancer recurrences.

Why is the expansion into Romania important?

Expanding into Romania allows more patients to access innovative treatments and contributes to global research on breast cancer.

How many clinical sites are involved in the trial?

Currently, there are around 150 approved sites globally, including the new Romanian sites.

Who is leading the clinical sites in Romania?

Dr. Nicoleta Antone, a prominent figure in breast cancer research, is leading the clinical sites in Romania for FLAMINGO-01.

What are the expected outcomes of this trial?

The trial aims to determine the effectiveness of GLSI-100 in preventing breast cancer recurrences in high-risk patients.

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