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Peregrine Pharma Begins Patient Enrollment In New Cotara Brain Cancer Trial [PPHM]
6/25/2007 11:10:48 AM Peregrine Pharmaceuticals Inc. (PPHM) revealed initiation of a new clinical trial designed to evaluate the safety and efficacy of its tumor necrosis therapy agent Cotara in patients with glioblastoma multiforme or GBM, a deadly form of brain cancer.
In pilot studies Cotara has shown encouraging results, demonstrating a 58% increase in the expected median survival time in a group of 28 patients suffering from recurrent late stage glioblastoma multiforme.
Peregrine believed that combined positive data from this new study in India and ongoing U.S. glioblastoma trials would provide a foundation for advancing Cotara into Phase III trials.
This multi-center open label Phase II safety and efficacy study is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. The study's primary objective is to confirm the maximum tolerated dose of Cotara in patients with GBM at first relapse. Secondary objectives include estimates of overall patient survival, progression free survival and the proportion of patients alive at six months.