Special Protocol Assessment
FDA Grants Special Protocol Assessment (SPA) for Confirmatory, Pivotal Phase III Study of OncoVAX® Colon Cancer Vaccine
An SPA provides a mechanism for the FDA and sponsors to reach agreement on the design, size, execution and analysis of a clinical trial that is intended to form the primary basis for regulatory approval.
If successfully completed, the pivotal Phase IIIb trial could form the basis of a biologics licensing application ("BLA") for OncoVAX® in the United States. The randomized multi-center study will be conducted in the US and Europe with 550 patients. An interim analysis will be performed one year following randomization of the last patient, with primary analysis conducted three years after all 550 patients have been randomized to the study. The previous Phase IIIa randomized study, published in The Lancet and Vaccine, demonstrated a statistically significant 33% increased overall survival and 40% reduction in deaths or recurrences in treated Stage II colon cancer patients, compared to controls at a five–year median follow-up.