TapImmune amends patient inclusion criteria for Phase 2 trial of TPIV200
TapImmune announced that, in coordination with the U.S. FDA, it has amended the patient inclusion criteria for its Phase 2 clinical trial of the company's T-cell therapeutic peptide vaccine TPIV200 to focus on women with Stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy. TapImmune has enrolled the first women under this amended study protocol, which expands the population of patients that can be addressed with TPIV 200 as a potential maintenance therapy designed to prevent disease recurrence. The Phase 2 ovarian cancer trial is a double-blind controlled study designed to examine the potential benefits of using the Company's lead product candidate TPIV200 following standard of care platinum-based chemotherapy in first remission. Study size was increased to 120 patients to better evaluate the effect of the immunotherapy and to achieve statistical significance of efficacy data. TPIV200 has Fast Track designation from the FDA and Orphan Drug status for ovarian cancer.