Greenwich LifeSciences’ Phase 3 trial protocol accepted by European regulators

Greenwich LifeSciences’ Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, is undergoing expansion into Europe. The company’s application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency – EMA – through EMA’s Clinical Trials Information System. The company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators’ requests for information have been addressed. The regulators have thus approved the clinical trial. The 5 individual countries in Europe will now make a final determination, and if acceptable, they will allow the first group of approximately 105 sites in Europe to begin initiation and activation.