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Greenwich LifeSciences Announces Publication of Positive Phase IIb Clinical Trial Data for GP2, Its Lead Drug Candidate for the Prevention of Recurring Breast Cancer
‒ Company now preparing to enter a phase III clinical trial ‒ Phase IIb clinical trial was a prospective, randomized, single-blinded, placebo-controlled,
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n‒ Company now preparing to enter a phase III clinical trial\n\n‒ Phase IIb clinical trial was a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites) trial led by MD Anderson and completed in 2018\n\n‒ 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)\n\n‒ GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays\n\n 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 publication of an abstract at the San Antonio Breast Cancer Symposium (SABCS). The abstract will be displayed as a poster on Wednesday, December 9, 2020 in a virtual format.\n\nThe study met all of its clinical endpoints for HER2/neu 3+ patients, concluding that the first 6 intradermal injections of GP2+GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery, and this reduction of recurrence rate was maintained over the gold standard of 5 years of follow-up. A pivotal Phase III trial is being initiated to treat HER2/neu 3+ patients in the neoadjuvant setting. GP2 may also be effective when used in parallel to trastuzumab based therapeutics or in combination with trastuzumab based therapeutics in HER2/neu 1-2+ or other HER2/neu expressing cancers.\n\nSnehal Patel, CEO of Greenwich LifeSciences, commented, “Approximately 50% of recurring patients do not respond to Herceptin or Kadcyla and still recur with metastatic breast cancer and a poor prognosis, where approximately 80-85% of recurring patients do not survive.”\n\n“The publication of this abstract shows that we met all of the endpoints for our Phase IIb clinical trial for HER2/neu 3+ patients, including safety, where no serious adverse events were observed. By substantially reducing the recurrence rate of the non-responders, we are addressing a large unmet need of women. If we are successful in reproducing our Phase IIb clinical trial ...