Antigenics granted Russian approval for cancer vaccine

The Russian Ministry of Public Health registration was based on results from the largest, randomized, Phase III kidney cancer trial ever completed in the adjuvant treatment setting. Findings from investigator-reported data showed that patients receiving Oncophage in the intermediate-risk population (stages I/II high-grade, III T1/2/3a low-grade) who were without disease at baseline (n = 362) demonstrated a clinically significant improvement in recurrence-free survival of approximately 45% over patients in the observation arm (P < 0.01; hazard ratio = 0.55). Although the median has not yet been reached, results from the 25th percentile indicate that recurrence-free survival was extended by approximately 1.7 years. To comply with US regulations for exporting biologics, Antigenics applied for an export license from the FDA. The company expects the FDA to take action on the license application within approximately 60 days of submission. Garo Armen, chairman and CEO of Antigenics, said: "We are very pleased that Oncophage is the first personalized cancer vaccine that will be available in any major country. Additionally we hope to file for the conditional approval of Oncophage in Europe this year."