Prima gets first approval for CAN-004 trial

The first regulatory agency has signed off on the amended protocol for Prima BioMed’s (ASX:PRR) CAN-004 ovarian cancer trial.

The Belgian Federal Agency for Medicines and Health Products (FAMHP) has approved the new protocol for the CAN-004 trial.

As per the amended design, CAN-004 will be a randomised phase II trial of Prima’s CVac ovarian cancer vaccine for the maintenance treatment of epithelial ovarian cancer in remission.

It will involve 210 cancer patients in remission after second-line platinum-based chemotherapy, in addition to the 76 patients in remission after first-line surgery and chemotherapy that had already been enrolled in the trial.

Late last year, Prima BioMed decided to re-evaluate the design of the trial based on the results of the previous CAN-003 trial.

The primary endpoint has been changed from progression-free to overall survival, because early data from the CAN-003 trial suggested that there would not be a statistically significant impact on progression-free survival.

The focus of the trial has meanwhile shifted to patients in second-line remission, because the CAN-003 results in fact suggested a strong trend towards increased progression-free survival in this cohort. The size of the trial was also scaled down from roughly 800 patients.

“We are pleased to have received approval for the CAN-004 protocol amendment in Belgium and we anticipate other regulators will soon follow,” Prima CEO Matthew Lehman reported. “It is exciting that we will soon be able to restart recruitment of the CVac clinical trial for ovarian cancer.”

Prima BioMed (ASX:PRR) shares grew 44% to $0.065 after the company announced the FAMHP’s decision on Friday. The shares were trading 13.85% lower at $0.056 as of around 1 pm on Monday.