Antigenics has initiated a Phase I/II clinical trial of Oncophage (vitespen), Antigenics' 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. 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 currently a fatal disease.
Derived from each individual's tumor, Oncophage, which is an investigational therapy, contains the "antigenic fingerprint" of the patient's particular cancer, and in theory 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.
The trial is designed to enroll approximately 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.