Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced interim median overall survival of 8.8 months (38 weeks, 40 patients at first relapse) from a phase II trial for Cotara in recurrent glioblastoma multiforme (GBM). Additional data from this trial will be presented in a poster, which was selected for an oral poster discussion at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois on Friday, June 3, 2011 from 5:00 to 6:00 PM CDT. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion therapy directly into the tumour, destroying the tumour from the inside out, with minimal exposure to healthy tissue.
"Cotara is a promising, single-infusion treatment approach to treating recurrent GBM, the deadliest form of brain cancer," said William R. Shapiro, M.D., vice chairman, Neurology at Barrow Neurological Institute and coauthor of the study. "GBM is one of the most critical unmet medical needs, and unfortunately typical patient prognosis is approximately 6 months at first relapse. In trials conducted to date, we have seen median overall survival of close to 9 months, and importantly have followed long-term survivors after a single, generally well-tolerated infusion of Cotara."
"As we prepare for a planned meeting with the FDA in the fourth quarter of this year to determine the optimal registration pathway for Cotara, we are pleased that Dr Vladimir Evilevitch, a nuclear medicine and oncology specialist, has joined our team to help advance this novel radiopharmaceutical therapy," said Joseph S Shan, vice president of clinical and regulatory affairs at Peregrine. "We are pleased that the Cotara data were selected for oral discussion at ASCO and we plan to include the most current interim data in this poster presentation. As the last patients in this trial completed treatment in December 2010, additional follow-up will be critical and we are excited to have Vladimir to support this program going forward."
Peregrine's phase II open-label, multicenter trial was designed to enrol 40 GBM patients at first relapse. The primary endpoint is safety and tolerability of the maximum tolerated dose, a single 25-hour interstitial infusion of 2.5 mCi/cc of Cotara. Secondary endpoints include overall survival, progression free survival, and proportion of patients alive at six months after treatments. In a prior phase II trial, median overall survival for patients treated with Cotara was 8.8 months (38 weeks).
Cotara has been granted orphan drug status and Fast Track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the FDA.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.