Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) has recently reported completion of patient enrollment in a dose confirmation and dosimetry trial of Cotara® in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM. Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is also being tested in a Phase II clinical trial in patients with recurrent GBM.

In the ongoing dose confirmation and dosimetry study, patients received a single treatment of Cotara and were evaluated for specificity of drug localization to the tumor, as well as for progression-free survival and overall patient survival. Initial data from the trial show that all of the patients in the first two completed study cohorts have survived longer than the expected six-month median survival time for GBM patients and they confirm Cotara’s targeting capabilities, indicating that it delivers more than 300-fold higher radiation levels to the tumor than to normal organs.

The main objectives of the open label dosing and dosimetry study are to confirm the maximum tolerated dose of Cotara, to determine radiation dosimetry and to assess overall patient survival, progression-free survival and the proportion of patients alive at six months following Cotara administration. In both ongoing clinical trials, Cotara is delivered using convection-enhanced delivery (CED), a method developed by the U.S. National Institutes of Health that targets the specific tumor site in the brain.

Interim data from the dosimetry trial presented at the Society of Nuclear Medicine 2009 Annual Meeting in June showed that in patients dosed in the first two cohorts of the study, the concentration of Cotara in brain tumors was on average more than 300-fold higher than in other normal organs. In addition, these patients had all either met or exceeded the expected median survival time for recurrent GBM patients. Interim data from a Phase II study of GBM patients who have experienced a first relapse was presented at the XIV World Congress of Neurological Surgery in September. It highlighted a subset of 10 GBM patients and included follow-up durations ranging from seven weeks to over 73 weeks, showing an interim median recurrence-free survival of 33 weeks and an interim median overall survival of 41 weeks. Patient enrollment in this trial has surpassed the half-way mark.

More than 70 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 long-term surviving patients from early GBM clinical studies now alive more than 8.5 years after treatment with Cotara. Expected survival for patients with GBM is approximately six months from the time of disease recurrence.

Overall, Cotara has been administered to a total of more than 120 patients with brain, colon, liver or other cancers. 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.

Cotara is an experimental treatment for brain cancer that 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 center of solid tumors. Cotara’s targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor 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 U.S. Food and Drug Administration.

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