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Data from Investigator-Sponsored Trial of Oncophage Cancer Vaccine,in Glioma Presented at American Association of Neurological,Surgeons Annual Meeting

prosan 20 with carmustine implant, MGI Pharma), the first approved local therapy for glioma.

Derived from each individual's tumor, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been granted fast track and orphan drug designations from the US Food and Drug Administration (FDA) in both metastatic melanoma and renal cell carcinoma.

Study Findings

The investigator-sponsored Phase 1/2 study is designed to evaluate the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma. The trial involves two cohorts of six patients, both receiving a minimum of four Oncophage injections: the first cohort receives biweekly vaccinations; the second cohort receives weekly vaccinations. Patients are monitored for immune response before and after Oncophage treatment using three different techniques.

According to investigators, no adverse events or toxicity identified were considered attributable to the vaccine. A tumor-specific immune response was detected after vaccination in all 12 patients. The investigators will continue to follow patients for overall survival. Researchers plan to present further results from the Phase 1/2 trial of Oncophage in late 2007 and submit the findings for peer-review publication. Based on these results, the Phase 2 portion of this study is expected to move forward in mid-2007.

"Our goal is to change the management of recurrent glioma from a life threatening disease, in which survival rates are typically 25 to 26 weeks, into a chronic disease with extended survival and improved quality of life for patients," said Dr. Parsa. "Alth
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