Research Project
9692484
Abstract TGF?NanoCap® is an oral combination of nanoparticulate transforming growth factor beta 1 (TGF?) and all- trans retinoic acid (ATRA) in pre-clinical development for treatment of inflammatory bowel disease (IBD). Phase I studies provided proof-of-principle for efficacy in a murine model. Phase II work optimized therapeutic protocol, confirmed efficacy in a second model, established scale-up manufacturing methods, completed rodent toxicology studies, and conducted a type C meeting with the FDA to gain guidance in support of an investigational new drug (IND) filing. The present application (according to FDA guidance) proposes additional rodent toxicology and formulation studies, synthesis and qualification of drug product for use in non-human primates, execution of a type B pre-IND meeting with the FDA and finally, required primate toxicology in support of an open IND application. Work will be performed in collaboration with Bend Research, Inc., Comparative Biosciences Inc. and Regulatory Professionals Inc., as well as with Dr. Peter Mannon, Professor of Medicine, Division of Gastroenterology & Hepatology, and Director Gastroenterology/Hepatology Clinical Research Program at the University of Alabama. Successful completion of the Phase IIb studies will facilitate the advancement of TGF?NanoCap® towards phase I/II clinical trials in patients with Crohn?s disease and ulcerative colitis.
