BURLINGTON, Mass., Aug. 14, 2012 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc., (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, announced today the initiation of TRUST- I ( TR ich Uris Suis ova Trial), a Phase 2 clinical trial of TSO ( Trichuris suis ova or CNDO-201) in patients with Crohn's disease. TSO, the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines.
"Previous investigator-initiated trials have demonstrated TSO's therapeutic potential to induce response and remission rates in inflammatory bowel disease patients," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "This Phase 2 study will expand our understanding of TSO's clinical usefulness in patients with moderately to severely active Crohn's disease."
TRUST-I is a randomized, double-blind, placebo-controlled, U.S. multicenter study designed to evaluate the safety and efficacy of TSO. Approximately 220 patients with Crohn's disease will be enrolled and randomized to receive either 7500 ova or placebo once every 2 weeks, for 12 weeks. The primary endpoint for the study is induction of response, as measured by the Crohn's Disease Activity Index (CDAI), with induction of remission being the secondary endpoint. The study is expected to be completed in the second half of 2013. Additional study details can be found at www.clinicaltrials.gov .Coronado's development partner for TSO in Crohn's disease, Dr. Falk Pharma GmbH, is also conducting a Phase 2 double-blind, randomized, placebo-controlled, multi-center study in Europe to evaluate the efficacy and safety of TSO in active Crohn's disease. "The use of TSO in the treatment of Crohn's disease and other autoimmune disorders is based on the hygiene hypothesis, which suggests the immune systems of people living in developed countries with little or no exposure to parasites may not be able to properly regulate themselves. This hypothesis is further supported by epidemiologic findings of an inverse relationship between autoimmune diseases and helminthic colonization, as well as pre-clinical data in different disease models," said Dr. Karin Hehenberger, Coronado's Executive Vice President & Chief Medical Officer.