Greenwich LifeSciences builds internal clinical operations team

Greenwich LifeSciences Inc. (NASDAQ: GLSI) announced plans to establish an internal clinical trial management and operations team to reduce reliance on external Clinical Research Organizations (CROs). The clinical-stage biopharmaceutical company stated this strategy aims to lower costs and increase efficiency for its ongoing Phase III clinical trial FLAMINGO-01.

The company has begun hiring staff to manage and operate FLAMINGO-01, which evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. VP Jaye Thompson stated the move to bring dedicated staff and contractors internally would reduce costs and improve efficiency while continuing to utilize select vendors for optimization.

CEO Snehal Patel said the internal clinical staff strategy is expected to reduce the company's baseline burn rate while improving data quality and site management for FLAMINGO-01. The internal team is also managing European clinical operations.

FLAMINGO-01 is a Phase III trial evaluating GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery. The trial, led by Baylor College of Medicine, includes US and European clinical sites with plans to expand to 150 sites globally. The double-blinded trial will randomize approximately 500 HLA-A*02 patients to GLSI-100 or placebo, with up to 250 patients of other HLA types receiving GLSI-100 in a third arm.

The company stated the internal staffing buildout aims to develop capability for conducting multiple trials simultaneously and potentially support additional pipeline indications or product lines.

You May Also Be Interested In

• Jefferies Reinstates Booz Allen Hamilton (BAH) at Hold
• Scotiabank Starts Perpetua Resources (PPTA) at Sector Outperform
• UBS Starts Assembly Biosciences (ASMB) at Buy