Antigenics initiates phase 1, 2 Oncophage trial for recurrent glioma

By E. Janene Geiss

Philadelphia, Nov. 21 - Antigenics Inc. announced Monday that the Brain Tumor Research Center at the University of California, San Francisco, has initiated a phase 1 and 2 clinical trial of Oncophage, the company's investigational patient-specific cancer vaccine, as a treatment for patients with recurrent glioma.

The primary goal of the study is to establish the feasibility, safety and preliminary efficacy of Oncophage vaccination in glioma patients, according to a company news release.

Derived from each individual's tumor, Oncophage contains the "antigenic fingerprint" of the patient's particular cancer. In theory, it is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint, officials said.

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 U.S. Food and Drug Administration in both metastatic melanoma and renal cell carcinoma.

The trial is designed to enroll about 60 patients with primary or recurrent high-grade glioma. Patients will undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines.

According to the protocol, primary patients will receive vaccine upon recurrence, whereas patients with recurrent disease will be treated after surgery.

The trial will sequentially evaluate the safety of three dosing regimens of Oncophage. The objectives are to determine the safety of Oncophage in this patient population, clinical response to therapy and immune response to therapy. It is supported through a grant from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence.

Glioma is a cancer affecting the central nervous system (brain and spinal cord) that begins in the connective tissue that surrounds and supports nerve cells. Malignant glioma is a fatal disease.

"Once patients with malignant glioma fail conventional therapy, such as radiation and chemotherapy, there are limited treatment options. Therapeutic vaccine approaches such as Oncophage offer the potential to specifically target tumor cells without injury to normal, healthy cells," said Andrew T. Parsa, assistant professor in the department of neurological surgery at the University of California, San Francisco, and principal investigator of the trial.

Antigenics is a New York City biotechnology company working to develop patient-specific immunotherapeutics and treatments for cancers, infectious diseases and autoimmune disorders.

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