A special protocol assessment (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.
“Intracel now has a clear path to drug approval,” stated Dr Mitchell Finer, Intracel’s CEO. “OncoVax has the potential to become the first adjuvant therapy for stage II colon carcinoma, where the current standard of care worldwide is surgery alone. This is the only immunotherapy product in development for the treatment of minimal residual disease, where immunotherapy products have the greatest chance for clinical success.”
If successfully completed, the pivotal phase III trial could form the basis of a biologics licensing application for OncoVax in the US. The randomized multi-center study will be conducted in the US and Europe with 560 patients enrolled over two years.
Intracel’s previous randomized study, published in the journals 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.