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Trials & Filings

CPP Begins FAP Trial

New model design aims to assess outcomes

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cancer Prevention Pharmaceuticals (CPP) has launched a double-blind, randomized, Phase III trial of the efficacy and safety of CPP-1X/sulindac (eflornithine/sulindac) compared with CPP-1X and sulindac as single agents in 150 patients with Familial Adenomatous Polyposis. Each patient will receive daily treatment for two years to minimize the occurrence and/or recurrence of problematic polyps and tumors associated with this debilitating disease. The trial is being conducted at eight North American and four European clinical trial sites.

The company has designed the trial to differ from past models. Rather than count polyps, which has been the past indicator of clinical success in pharmacoprevention trials in FAP, the trial will assess meaningful clinical outcomes in patients.

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