CLSN - NOV 26:
is currently conducting the OVATION 2 clinical trial of GEN-1 in patients with advanced ovarian cancer (Stage III/IV). It is a Phase 1/2 randomized, open label, multicenter trial to evaluate the safety, efficacy, and biological activity of intraperitoneal GEN-1 plus neoadjuvant chemotherapy (NACT), compared to NACT alone. Up to 110 patients are anticipated to be enrolled in the trial. The Phase 1 run-in portion of the study began with 14 patients receiving 100 mg/m2 of GEN-1, as the highest amount of GEN-1 studied prior to this trial was 79 mg/m2. The primary endpoint is progression free survival (PFS), which will be evaluated following 80 PFS events or 16 months, whichever is longer. Secondary endpoints include clinical response (ORR), pathological response, surgical resection scores, biological response, and safety. The trial is designed with an 80% confidence interval for an observed PFS hazard ratio (HR) of 0.75, which would correspond to an approximately 33% improvement in risk for cancer progression when comparing GEN-1+NACT to NACT alone.