Prima BioMed falls on Phase II data for CVac
Prima BioMed Ltd. (ASX:PRR; NASDAQ:PBMD) was off $0.74 (31%) to $1.61 on NASDAQ on Wednesday after reporting no observed difference between the CVac and observation arms in estimated median progression-free survival (PFS), the primary efficacy endpoint, in the Phase II CAN-003 trial to treat ovarian cancer in patients in first or second remission. The company said it will monitor patients until overall survival (OS) data are mature. Prima BioMed said the trial, which enrolled 63 patients, was not powered for significance. Data will be presented at the European Cancer Congress in Amsterdam on Oct. 1.
Prima BioMed said it will meet with regulatory authorities "promptly" to discuss endpoints for evaluating clinical benefit in ovarian cancer patients. Until then, the company has suspended enrollment in the Phase II/III CANVAS trial evaluating CVac as maintenance treatment of epithelial ovarian, primary peritoneal or fallopian tube cancer patients in complete remission. CANVAS had been designed with a primary endpoint of PFS. ...