Peregrine Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, is presenting data from a phase II trial of Cotara in recurrent Glioblastoma Multiforme (GBM) at an oral poster discussion at 5:00 PM CDT at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

In 41 patients treated at first relapse with a single infusion of Cotara, interim Median Overall Survival (MOS) is 8.8 months (38 weeks). Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion therapy directly into the tumour, destroying the tumour from the inside out, with minimal exposure to healthy tissue.

“We know of no other recurrent GBM therapy that has achieved comparable median overall and long-term survival using a single administration of one drug and we are eager to meet with the FDA in the fourth quarter to determine the optimal registration pathway for our novel brain cancer therapy Cotara,” said Steven W King, president and chief executive officer of Peregrine. “Recurrent GBM is one of the most critical unmet medical needs as patients have limited treatment options. Additional therapeutic options with the potential for new combination regimens that extend patient survival are urgently needed. As a single-treatment approach showing promising signs of overall survival and a good safety profile to date, Cotara may offer advantages when administered alone or in combination with other therapies for patients with this deadliest form of brain cancer.”

Peregrine's phase II open-label, multi-centre trial enrolled 41 GBM patients at first relapse. The primary endpoint was safety and tolerability of the maximum tolerated dose, a single 25-hour interstitial infusion of 2.5 mCi/cc of Cotara. Secondary endpoints include overall survival, progression free survival, and proportion of patients alive at six months after treatments. Median overall survival for patients treated with Cotara was 8.8 months (38 weeks), consistent with a prior phase II trial. Currently, patients alive at six-months, 12-months and 24-months are 73%, 38% and 19%, respectively, and two patients have survived three years after a single treatment with Cotara.

Patient characteristics were median age of 52 years (range of 24 and 74 years), median clinical target volume of 28 cm(3) (range 2 and 66 cm(3)) and median Karnofsky Performance Status (KPS) of 80. Cotara was generally safe and well tolerated. The most common drug-related Adverse Events (AEs) were neurologic in nature and most were managed with corticosteroids.

Based on Peregrine's Tumour Necrosis Therapy (TNT) platform, Cotara is a novel phase II therapy for the treatment of recurrent GBM. Cotara 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 centre of solid tumours. Cotara's targeting mechanism enables it to bind to the dying tumour cells, delivering its radioactive payload to the adjacent living tumour cells and essentially destroying the tumour from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered in a single dose using Convection-Enhanced Delivery (CED), an NIH-developed method that targets the specific tumour site in the brain.

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).

According to the American Cancer Society, in 2010 there will be an estimated 22,000 malignant tumours diagnosed and approximately 13,000 deaths attributed to brain or spinal cord cancer in the United States. The most common type of brain cancer is Glioblastoma Multiforme (GBM), which accounts for 60% of all malignant brain cancers. An aggressive form of cancer, GBM is the deadliest form of brain cancer, with a five-year survival rate of only 3%.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.