Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that clinical investigators are presenting interim Phase II data showing that its brain cancer agent Cotara(R) appeared well tolerated and demonstrated encouraging signs of efficacy in patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer. The data from an ongoing Phase II study of Cotara in patients with recurrent GBM is being presented today at the XIV World Congress of Neurological Surgery Annual Meeting by Dr. Deepak Gupta, assistant professor of neurosurgery at the All India Institute of Medical Sciences (AIIMS) in New Delhi on behalf of the Cotara study team that includes Drs. A.K. Mahapatra, Ashish Suri and C.S. Bal.
Dr. Gupta will present interim data for 10 recurrent GBM patients at first relapse treated at AIIMS as part of an ongoing 40 patient Phase II clinical trial. Eight males and two females with a mean age of 51 years received a single intratumoral infusion of Cotara. Currently, follow-up duration ranges from between seven to over 73 weeks with an interim median recurrence-free survival of 33 weeks and an interim median overall survival of 41 weeks. Expected survival for patients with GBM is approximately 24 weeks from time of disease recurrence. Based on this interim data, the study authors conclude that Cotara appears to be feasible, tolerable and has encouraging signs of efficacy in recurrent GBM patients.
"This interim data from our Phase II trial suggests that Cotara has the potential to be a valuable new therapy for patients with glioblastoma, a devastating disease with few treatment options," said Dr. A.K. Mahapatra, professor of neurosurgery at AIIMS and principle investigator on the Cotara study. "Our experience to date with Cotara shows that it is feasible to administer and is quite well tolerated in these very ill patients. Most importantly, Cotara has demonstrated promising signs of efficacy. We look forward to enrolling more GBM patients in the Cotara trial over the coming months and to further assessing the experience of the patients treated to date."
The Cotara Phase ll multi-center open label study is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. The primary objective of the trial is to confirm the maximum tolerated dose of Cotara in GBM patients at first relapse. Secondary objectives include estimates of overall patient survival, progression-free survival and the proportion of patients alive at six months. Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), a technique that delivers the agent to the tumor with great precision. Brain scans are administered at eight-week intervals post-treatment. The study is being conducted according to internationally accepted ICH and GCP guidelines.