Business
Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space
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 that it has entered into a contract for the final formulation and filling of GP2 into vials, which when completed will allow for the storage and distribution of GP2 to clinical sites. The contract manufacturer plans to commence activities in 2021. In addition, the Company has leased office, laboratory, and storage space to provide research, manufacturing, and clinical trial support activities.\n\nSnehal Patel, CEO of Greenwich LifeSciences, commented, “We are pleased to have entered into these key manufacturing and facility agreements, which along with the continued recruitment of key opinion leaders and clinical sites, will be some of the major last steps before commencing the upcoming Phase III clinical trial.”\n\nThe Company’s new manufacturing partner specializes in the current Good Manufacturing Practice (cGMP) of formulating, filling, and labeling drug vials and follows the recent completion of the manufacturing of the GP2 active ingredient.\n\nThe Company’s new facility is located in Stafford, Texas and will enable the Company to support its manufacturing activities, develop analytical methods, and process clinical trial samples. The facility may also be instrumental in supporting potential additional research and development activities into other drug products that could complement the GP2 immunotherapy platform and expand the pipeline of the Company.\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 patie...