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ARTICLE | Clinical News

Cotara: Additional Phase II data

June 6, 2011 7:00 AM UTC

Additional data from an open-label, U.S. and Indian Phase II trial in 41 GBM patients at first relapse showed that a single 25-hour interstitial infusion of 2.5 mCi/cc Cotara led to an interim median OS of 38 weeks. Peregrine previously said expected survival for patients with GBM is typically 24 weeks from the time of disease recurrence. Additionally, 73%, 38% and 19% of patients were alive at 6, 12 and 24 months, respectively, and 2 patients have survived 3 years following treatment. Cotara was well tolerated with brain edema and convulsions reported as the most common adverse events. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Peregrine plans to meet with FDA in 4Q11 to define the optimal registration pathway for Cotara. ...