Prima wins more approvals for ovarian cancer trial
Prima BioMed (ASX:PRR) has secured regulatory approval in four more European markets for its revised CAN-004 trial of cancer vaccine candidate CVac in epithileal ovarian cancer.
Regulators from Latvia, Lithuania, Ukraine and Belarus have approved the amended trial protocol, weeks after the company was granted approval by Belgian regulators.
Prima still requires regulatory approval in the US, Australia, Germany, Poland and Ukraine.
The trial has also been approved by ethics committees and review boards from sites in the US, Australia, Belgium, Bulgaria, Latvia and Lithuania.
The CAN-004 trial will be a randomised, phase II trial of CVac for the maintenance treatment of epithelial ovarian cancer.
It will involve 210 patients in remission after second-line chemotherapy, as well as the 76 patients in remission after first-line chemotherapy and surgery that had already been enrolled into the first stage of the trial.
The trial was scaled back from the planned 1000 patients, and the primary endpoint changed from progression-free to overall survival, based on the results of the earlier CAN-003 trial.
“We are pleased that the CAN-005 amendments have been promptly reviewed and approved by a number of regulatory agencies and ethics committees,” Prima CEO Matthew Lehman said. “Our plans to start recruitment of the 210 ovarian cancer patients in second remission are on schedule.”
Prima BioMed (ASX:PRR) shares were trading 11.11% higher at $0.05 as of around 12.30 pm on Thursday.
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