Peregrine Pharmaceuticals (NASDAQ:PPHM) has reported promising interim data from an ongoing phase II clinical trial for its brain cancer drug Cotara, the company said Friday.
The trial tested patients with recurrence of glioblastoma multiforme (GBM), the most common and aggressive type of primary brain tumour, where people are typically expected to live for 24 weeks. GBM accounts for 60% of all malignant brain cancers.
The study showed that interim median overall survival was 86 weeks for a cohort of 14 patients, with a mean age of 48.5 years with GBM, who were treated at first relapse with a single infusion of Cotara, the company said.
Cotara is an experimental therapy and works as a targeted monospecific antibody linked to a radioisotope that is administered directly into the tumour, destroying it from the inside out, and having 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 vice president of clinical and regulatory affairs, Joseph S. Shan, M.P.H.
The interim results form part of an ongoing phase II trial of up to 40 patients with GBM at first relapse, at sites in the U.S. and India, 15 of which were enrolled at the lead clinical site in New Delhi. Data was available for 14 of the patients, which showed median overall survival of 86 weeks, and follow-up duration ranges of between four to 107 weeks.
In addition, the company said that studies showed the drug was well-tolerated and active in patients.
Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme by the U.S. FDA. The company plans to complete enrollment of the few remaining patients in the phase II trial before the end of the year, and report data by mid-year 2011. Once the data is analyzed, Peregrine will meet with the FDA to determine the best registration path for the drug, it said.
According to the American Cancer Society, in 2010, there will be an estimated 22,000 malignant tumors diagnosed and approximately 13,000 deaths attributed to brain or spinal cord cancer in the United States. Approved therapies for GBM currently include Temodar and Avastin, both of which have "modest effect" on patient survival, according to the company.
Aside from Cotara, Peregrine is pursuing a treatment for hepatitis C virus infection with its lead product bavituximab.
Disclosure: No position