Prima BioMed Announces Top-line Analysis Of CAN-003 Phase 2 Study

(RTTNews) - Prima BioMed Ltd (PBMD) Wednesday announced top-line analysis of the CAN-003 phase 2 study of CVac for treatment of epithelial ovarian cancer patients in first or second remission, indicating that the product was well tolerated, with no serious adverse events. The company said that no evidence was seen of a antibody response after CVac administration which is also considered a positive signal.

The company said that though the study was not powered to detect statistical significance, the estimate of median progression-free survival or PFS for all randomized patients resulted in no observed difference between the CVac and control groups.

The comapny added that it would continue to monitor patient outcomes on the CAN-003 trial until overall survival data matures, as it is considered too early to make conclusion based on Overall Survival data.

Prima will engage with regulators to make appropriate amendments to the clinical development plan for CVac in ovarian cancer and identify the most appropriate endpoints for evaluation of clinical benefit. Till then, the company has temporarily suspended enrollment on its CAN-004 clinical trial, which had been designed with PFS as the primary endpoint.