Cancer Prevention Pharmaceuticals, Inc. received positive advice from the European Medicines Agency (EMA) regarding its Phase III trial in Familial Adenomatous Polyposis (FAP).
The EMA advice included agreement on design features such as its clinically important endpoint, study duration, statistical analysis plan, and comparator arms. The EMA’s advice is consistent with guidance received from the FDA earlier this year and the company is now poised to begin a multinational study in FAP that will be used to support registration in both European Union and the United States.
The CPP study is a departure from previous and traditional trial designs that focused on “polyp counting.” Celecoxib was previously approved for FAP using the polyp counting endpoint with only a 28% reduction in polyp burden but unfortunately never translated into a standard of care or proven clinical benefit. The FAP indication was recently withdrawn from the Celecoxib label. In a departure from these endpoints, CPP will target a delay in FAP-related events such as surgical events, duodenal disease, cancer, and death , which are now accepted by the regulators as “clinically meaningful.”
Release Date: July 27, 2011
Source: Cancer Prevention Pharmaceuticals, Inc
Filed Under: Drug Discovery