Oncophage brain cancer vaccine (Vitespen) shows promise in extending survival recurrent glioma: Antigenics

Oncophage cancer vaccine (Vitespen) to treat recurrent brain cancer glioma has shown encouraging results in clinical studies, Antigenics said.

In the first 20 patients treated with oncophage show a median survival of 10.1 months. While survival data continues to accrue on all patients in the study, to date six patients (30 percent) have survived at or beyond 12 months, Antigenics data showed.

These early data on oncophage show an improvement in overall survival over the previous long standing historical median survival of 6.5 months, and slightly favorable to the recently reported median survival of 9.2 months1 with bevacizumab (Avastin) in patients with recurrent high-grade glioma.

“These are encouraging results that suggest activity with Oncophage in this challenging patient population,” said Andrew T Parsa, MD, PhD, associate professor in the department of neurological surgery at UCSF, and principal investigator of the trial, who presented the update.

Quality of life is particularly important and to date there have been no significant events or toxicity considered attributable to oncophage cancer vaccine (Vitespen), he added.

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 studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in Phase 2 trials in recurrent and newly diagnosed glioma.

The Phase 2 single-arm trial with oncophage cancer vaccine (Vitespen)is designed to enroll about 50 patients with recurrent high-grade glioma. The overall goal of this NIH-sponsored, investigator-initiated, open-label study is to evaluate median overall survival,
progression-free survival and immunologic response to oncophage cancer vaccine (Vitespen)treatment.

Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines.

Patients receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion.

To date, side effects observed in this study have been minor and have included injection-site reaction, fatigue, and headaches. The trial is supported through a grant from the National Institutes of Health.

An additional Phase 2 study is underway evaluating Oncophage in combination with Temodar (temozolomide) in newly diagnosed glioma patients.

Antigenics has treated nearly 800 patients in clinical trials throughout North America and Europe with oncophage produced in their commercial facility located in Lexington, Massachusetts. Studies with oncophage have demonstrated efficacy signals in multiple cancers, including melanoma, glioma, colorectal, pancreatic,renal cell carcinoma, gastric cancer and non-hodgkins lymphoma.

In April 2008, Oncophage was approved in Russia for the adjuvant treatment of
kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities of oncophage are ongoing.

Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.

In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.

About 22,070 malignant tumors of the brain or spinal cord will be diagnosed during 2009 in the United States, the American Cancer Society estimates. About 12,920 people will die from these tumors. Primary malignant brain tumors are uniformly fatal, and the five-year survival rate for the highest grade of malignant glial neoplasm, glioblastoma multiforme, is less than 2 percent. Brain and spinal cord tumors account for about 1 percent of all cancers and 2 percent of all cancer-related deaths.

Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.

Antigenics announced that the Brain Tumor Research Center at the University of California, San Francisco (UCSF), has presented an update on a Phase 2 clinical trial of Oncophage (vitespen) for recurrent high grade glioma (brain cancer) at the 2009 Joint Meeting of SNO (Society for Neuro-Oncology) and AANS/CNS Section on Tumors 2009 in New Orleans, LA.