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|  |  Antigenics Jumps On Phase 3 Melanoma Drug DataPress Release October 11, 2005 NEW YORK, Oct. 10 /PRNewswire-FirstCall/ -- Antigenics Inc. , the world leader in heat shock protein technology, today announced findings from its preliminary analysis of a randomized Phase 3 study of Onco phage(R) (vitespen; formerly HSPPC-96) in patients with metastatic melanoma. The study, which is not intended for registration, showed that in all randomized (intent-to-treat) stage IV M1a patients, median survival improved by more than 50 percent in the Oncophage-treated arm compared with those in the physician's choice treatment arm (20.9 months versus 12.8 months), which included the current array of therapies such as chemotherapeutics, biological agents and/or surgery. This is the first Phase 3 randomized trial of a cancer vaccine to show a potential survival benefit in this category of melanoma patients. Comparison of survival data of the two groups in stage IV M1a category was made using the Kaplan-Meier method.(1) The survival curve in the Oncophage arm clearly separates from the physician's choice arm, and the difference appears indicative of a clinical benefit for Oncophage-treated stage IV M1a patients. The difference has not achieved statistical significance at the time of this preliminary analysis. A final analysis is expected during the first quarter 2006. The M1a category of stage IV melanoma patients (a category defined by the American Joint Committee on Cancer, or AJCC) was prospectively stratified for this trial. Patients in this category are routinely identified in a clinical setting with distant metastases in the skin, subcutaneous tissue or distant lymph nodes. "This potential benefit with heat shock protein vaccination in stage IV M1a advanced melanoma is encouraging and consistent with the concept that immunological therapy is most appropriate for patients with M1a disease," said John M. Kirkwood, MD, director of the Melanoma Center at The University of Pittsburgh Cancer Institute, and professor and vice chairman for clinical research in the university's department of medicine. "These patients are the appropriate target for the most advanced molecular and vaccine interventions. It is in these patients that application of immunological therapies such as the heat shock protein vaccine Oncophage could likely achieve its greatest therapeutic impact." Based on these findings, as well as the advice received during an international panel of melanoma experts, held on October 7, 2005, Antigenics plans to commence a Phase 3 study for the purposes of registering Oncophage in this patient group. "These findings further validate our technology platform and our ability to create personalized cancer vaccines in a real-life setting. We look forward to discussing our results with the FDA and developing a strategy for registration," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "These data are entirely consistent with the extensively published work with the heat shock protein approach and the mechanism through which it acts," said Pramod K. Srivastava, PhD, founding scientist of Antigenics, and Professor and Chairman of the Department of Immunology at the University of Connecticut School of Medicine. "These results lay the clinical foundation for the development of the heat shock protein approach against a wide range of common solid cancers, such as those of colon, lung, breast, prostate, ovary and other tissues."
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