Phase III Colon Cancer Prevention Therapy Trial Now Open for Enrollment

Cancer Prevention Pharmaceuticals, Inc., (CPP) announced today the launch of a Phase III colon cancer prevention trial in collaboration with the National Cancer Institute (NCI) and SWOG, an NCI-supported clinical trials group. The Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) trial is a Phase III trial testing CPP’s prevention therapy product CPP-1X/sul (eflornithine/sulindac) in 1340 colon cancer survivors—each of whom will receive daily treatment for three years to prevent the recurrence of cancer or high-risk polyps.Continue reading

FDA Support for Developing Products for Rare Diseases & Conditions

The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.  In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.Continue reading