The phase I/II study is designed to establish the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma.
Preliminary results from the first cohort in the study showed that Oncophage vaccination was associated with tumor-specific immune response in six treated patients with recurrent, high-grade glioma. Malignant glioma is currently a fatal disease.
“This is the first documentation of a glioma-specific immune response after vaccination with Oncophage,” said Andrew Parsa, assistant professor, department of neurological surgery at the University of California.
“Further studies are certainly warranted to definitively determine the benefit of Oncophage in this patient population.”
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 FDA in both metastatic melanoma and renal cell carcinoma.
Based on these preliminary findings, a larger phase II study is planned for 2007.