Greenwich LifeSciences Announces New Manufacturing Agreement for its Planned Phase III Clinical Trial and Enters into Lease for Office and Lab Space
Greenwich LifeSciences (Nasdaq: GLSI) has secured a contract for the final formulation and filling of its GP2 immunotherapy, aimed at preventing breast cancer recurrences. The contract will enable the storage and distribution of GP2 to clinical sites, with activities starting in 2021. The company has also leased a facility in Stafford, Texas, to support its manufacturing and research initiatives. CEO Snehal Patel expressed optimism about these developments as crucial steps towards commencing the Phase III clinical trial following promising Phase IIb results, showing no recurrences after a median follow-up of five years.
- Contract secured for final formulation and filling of GP2, aiding future distribution.
- Leased new facility in Stafford, Texas for research, manufacturing, and clinical support.
- CEO confirms successful Phase IIb trial results with no recurrences after median 5 years follow-up.
- None.
STAFFORD, Texas--(BUSINESS WIRE)--Greenwich 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.
Snehal 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.”
The 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.
The 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.
About Breast Cancer and HER2/neu Positivity
One 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
About Greenwich LifeSciences, Inc.
Greenwich 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 protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company’s website: www.greenwichlifesciences.com
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.
