Peregrine Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, reported interim data from an ongoing phase-II clinical trial of its novel brain cancer therapy Cotara. Interim median overall survival was 86 weeks for a cohort of 14 patients with glioblastoma multiforme (GBM) treated at first relapse with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered directly into the tumour, destroying the tumour from the inside out, with minimal exposure to healthy tissue.
"Interim survival data from patients treated with Cotara have been encouraging, previously ranging from 38 to 41 weeks, when expected survival for these patients is typically 24 weeks from time of disease recurrence," said Joseph S Shan, M.P.H., vice president, clinical and regulatory affairs of Peregrine Pharmaceuticals. "We look forward to completing enrolment of the few remaining patients in this phase-II trial before the end of this year and reporting data by mid-year next year. Once this trial is completed and we have analyzed the data, we plan to meet with the FDA to determine the optimal registration pathway for Cotara."
As part of an ongoing phase-II clinical trial of 40 patients with GBM at first relapse, 15 GBM patients (mean age 48.5 years) were enrolled at the All India Institute of Medical Sciences (AIIMS) in New Delhi, India, the lead clinical site. Interim data available for 14 of these patients showed median overall survival of 86 weeks and follow-up duration ranges from between four and 107 weeks. Cotara has been granted orphan drug status and Fast Track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the US Food and Drug Administration (FDA).
"Overall median survival of 86 weeks far exceeded our expectations in this very difficult to treat patient population where treatment options are few and rarely extend median survival beyond six months," said Deepak Gupta, assistant professor of neurosurgery at AIIMS. "Interim data indicate that Cotara appears well-tolerated and active in GBM patients studied. We believe Cotara represents a promising experimental therapy for patients with this most deadly form of brain cancer."
These new interim data are being presented in a poster at the 2010 Congress of Neurological Surgeons (CNS) Annual Meeting in San Francisco, California. The CNS is a world leader in neurosurgical education and innovation with over 7,000 members worldwide.
Cotara Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumours.
Peregrine Pharmaceuticals is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.