Final Data From Phase 1 Investigator-Sponsored Trial of Oncophage® Cancer Vaccine in Glioma Presented at the Society for Neuro-Oncology's Annual Meeting

24 November 2008

Final Data From Phase 1 Investigator-Sponsored Trial of Oncophage® Cancer Vaccine in Glioma Presented at the Society for Neuro-Oncology's Annual Meeting

Overall Median Survival Extends to 10.5 months in Patients after Surgery with Multiple Recurrent Brain Cancer

Antigenics Inc. announced an oral presentation of final data from a Phase 1 investigator-sponsored trial of the company's investigational cancer vaccine Oncophage® (vitespen) in recurrent, high-grade glioma at the Society for Neuro-Oncology's 13th Annual Scientific Meeting in Las Vegas.

Final results from the study, conducted at the Brain Tumor Research Center at the University of California, San Francisco, showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. This is compared to a historical median survival of only 6.5 months post surgery. All patients enrolled into the trial had at least one recurrence of brain cancer.

"These are the most challenging patients to treat because their survival is typically three to six months," said Andrew T. Parsa, MD, PhD, associate professor in the department of neurological surgery at the University of California, San Francisco. "These preliminary results suggest a possible impact on survival as well as a very favorable safety profile."

In addition to survival data, the study also observed a correlation between immune response and overall survival as a result of Oncophage vaccination (n=12; P < .001). These responses were validated by using three separate immune techniques and showed that Oncophage evoked a tumor-specific immune response by producing activated T-cells and natural killer cells that can destroy tumor cells.

"Gliomas develop built-in immunoresistant pathways which play an important role in tumor progression," said Dr. Parsa. "This study demonstrated significant tumor-specific immune responses leading to a proliferation of T-cells which did not exist in these patients before vaccination with Oncophage. We look forward to completing the Phase 2 portion of this study and presenting results next year."

Study Design and Findings

The investigator-sponsored Phase 1/2 study was designed to evaluate the feasibility, safety and activity of Oncophage vaccination in patients with recurrent, high-grade glioma. Patients were monitored for immune response before and after Oncophage treatment using three different techniques.

According to investigators, no adverse events or toxicities identified were considered attributable to the vaccine. A tumor-specific immune response was detected after vaccination in all 12 patients.

Source BusinessWire