Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today announced initiation of a new clinical trial designed to evaluate the safety and efficacy of its tumor necrosis therapy (TNT) agent Cotara(R) in patients with glioblastoma multiforme (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. This was considered a promising development in this serious and deadly disease, which kills half of its victims within 14 months of diagnosis.
Peregrine believes 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.
"Cotara has demonstrated promising increases in survival in previous clinical studies of late stage glioblastoma patients, and we are optimistic that the very large population of glioblastoma patients served by our Indian study centers will facilitate timely enrollment in this important new trial," said Steven W. King, president and CEO of Peregrine. "We anticipate that positive data from this study, together with dosimetry and dosing data being collected in ongoing U.S. Cotara trials, will help us determine the optimal design of Phase III product registration 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. Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), an NIH-developed technique that delivers the agent to the tumor with great precision, achieving up to a 10,000-fold greater concentration in local therapy exposure than conventional intravenous drug administration, while minimizing unwanted exposure to healthy tissue. This delivery method is expected to further enhance the tumor-killing efficacy of Cotara.
Mr. King continued, "We are launching this Cotara clinical program in India to take advantage of the large population of GBM patients served by our study centers and the high level of experience with CED delivery of the participating neurosurgeons, as well as the fact that the contract research organization overseeing the trial is highly experienced in conducting similar glioblastoma trials with many of the investigators involved with our study."
The new Cotara study is being conducted according to internationally accepted ICH GCP guidelines.
Source: PR Newswire