Greenwich LifeSciences granted Fast Track designation for GLSI-100 by FDA

Greenwich LifeSciences (GLSI) announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. The designation specifically states that “GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation. In the prospective, randomized, single-blinded, placebo-controlled, multi-center Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows: 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products; Peak immune response at 6 months; No reported serious adverse events attributable to treatment Well-tolerated safety profile; Full immunization was received in the Primary Immunization Series, which included the first 6 GLSI-100 injections over the first 6 months.