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news.A vaccine manufactured by Antigenics for treating a recurrent cancer of the central nervous system that occurs primarily in the brain has shown promise in preliminary data from a phase I/II clinical trial.
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The trial is designed to establish the feasibility, safety and preliminary efficacy of vaccination in patients with recurrent, high-grade glioma, a fatal disease.
Findings from a group of 12 study patients showed that vitespen vaccination, trademarked as Oncophage, was effective in stimulating the patient’s immune system to attack the tumor cells. All patients showed an immune response.
Of the 12 patients being treated, eight can currently be evaluated for overall survival, while four are still receiving treatment. Seven out of the eight patients have exceeded the historical median benchmark of 6.5 months survival from time of recurrence. The investigators will continue to follow the patients for overall survival. According to investigators, no adverse events or toxicity identified were considered attributable to the vaccine. Based on these results, a larger phase II study is planned for late 2007.
The vaccine 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. Vitespen has been granted fast-track and orphan drug designations from the FDA for both skin cancer and kidney cancer.