Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single dose directly into the tumor, irradiating the tumor from the inside out, with minimal exposure to healthy tissue.
Interim median overall survival for patients treated with Cotara has ranged from 38 to 41 weeks, with 86 weeks from 14 patients at a single medical center. Expected survival is only approximately 24 weeks for recurrent GBM patients. Cotara has been granted orphan drug status and fast track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration.
"As currently approved therapies have failed to improve overall survival for recurrent GBM patients, the interim overall survival reported to date from our Cotara trials has been quite remarkable and we are eager to advance our treatment into a registrational trial," said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine. "We expect top-line data to be available by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara."