Business
Greenwich LifeSciences, Inc. Announces Completion of Manufacturing of Drug for its Planned Phase III Clinical Trial
STAFFORD, Texas--(BUSINESS WIRE)-- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":" STAFFORD, Texas--(BUSINESS WIRE)--\nGreenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the completion of the manufacturing of the GP2 active ingredient for its planned Phase III clinical trial. After having met all drug specifications and release criteria in compliance with current Good Manufacturing Practice (cGMP), the GP2 active ingredient has been released for formulation and filling into vials, which is the last step before storage and distribution of GP2 to clinical sites.\n\nSnehal Patel, CEO of Greenwich LifeSciences commented, “We are pleased to have completed this major manufacturing milestone. Last week we completed our IPO, in which members of senior management and directors invested funds aggregating in approximately 15% of the IPO gross proceeds. Our success in scaling up GP2 to large scale cGMP manufacturing and our recent fundraising moves us closer to commencing the upcoming Phase III clinical trial.”\n\nThe Company’s commercial manufacturing partner, Polypeptide Laboratories, located in San Diego, California and a specialist in the manufacture of clinical and commercial grade peptides, initiated this clinical lot in 2019, which is at a commercial scale that can produce 50,000 doses and treat up to 4,500 patients. In addition, analytical methods were validated and a stability program has been initiated per cGMP requirements.\n\nAbout Breast Cancer and HER2/neu Positivity\n\nOne in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.\n\nAbout Greenwich LifeSciences, Inc.\n\nGreenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu pr...