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The Lancet Oncology

Wednesday, September 2, 2009

Interim Phase II Data Supports Potential of Cotara for Treatment of Brain Cancer

Interim data from a lead clinical site in ongoing phase II clinical study evaluating Cotara, a monoclonal antibody that targets the DNA of cancer cells and carries a radioactive isotope, in patients with recurrent glioblastoma multiforme, or GBM, presented at XIV World Congress of Neurological Surgery (hosted by the American Association of Neurological Surgeons (AANS) from August 30-September 4, 2009 in Boston, USA), shows that the new treatment is generally well tolerated with encouraging signs of efficacy.

Patients with recurrent glioblastoma multiforme, or GBM, treated with a single dose of Cotara as monotherapy had interim median recurrence-free survival of 33 weeks and median overall survival of 41 weeks. The expected survival for Patients with GBM is approximately 24 weeks from time of disease recurrence.

Peregrine Pharmaceuticals, a biopharmaceutical company, today reported that clinical investigators are presenting interim Phase II data showing that its brain cancer agent Cotara 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 presented interim data of 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 expCursieferience 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.

"The interim data being presented today for the GBM patients treated at AIIMS supports the meaningful signs of clinical activity seen in prior Cotara trials as measured by median overall survival," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine.

"Previous clinical data presented earlier this year has shown the ability of Cotara to specifically deliver high doses of radiation to GBM tumors, resulting in significant anti-tumor effects. The early data from this ongoing Phase II study is providing further evidence that Cotara's ability to target tumors with great specificity may provide clinical benefit to patients with this devastating disease. We look forward to completing enrollment and reporting data on the entire trial as soon as possible."

More than 65 patients with recurrent GBM have received Cotara in the current and previous clinical studies. Localization and accumulation of the drug to the tumor have been excellent and longer-term survivors (greater than one year from the time of Cotara treatment) have been observed in all of the trials, with some recurrent GBM patients from early clinical studies now alive more than 8.5 years after treatment with Cotara. Expected survival for patients with GBM is approximately 24 weeks from time of disease recurrence.

Overall, Cotara has been administered to a total of more than 125 patients with brain, colon or liver cancer. Promising data from these studies support Cotara's ability to specifically target solid tumors and its anti-tumor activity, as well as its acceptable safety profile.

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