BURLINGTON, Mass., Dec. 21, 2012 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today the signing of a Clinical Trial Agreement between the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and Coronado Biosciences to evaluate TSO ( Trichuris suis ova or CNDO-201) for the treatment of ulcerative colitis (UC) in a phase 2 clinical trial. This multi-center study will be conducted by the NIAID-funded Autoimmunity Centers of Excellence (ACE).
"We are pleased that the ACE and NIAID have decided to fund a multi-million dollar study to evaluate TSO in UC patients, which shows further support for the hygiene hypothesis and TSO. Having this agreement in place advances the clinical development of TSO in ulcerative colitis into a phase 2 trial," said Dr. Bobby W. Sandage, Jr., President and CEO of Coronado. "This study further builds on our strategy of continuing support for investigator-initiated clinical trials evaluating TSO in a broad range of autoimmune diseases, while focusing our internal clinical development efforts and resources on our lead indication, Crohn's disease."
The phase 2 trial is a randomized, double-blind, placebo-controlled clinical study designed to examine the safety and efficacy of TSO treatment in active left-sided ulcerative colitis and its effects on mucosal immune state and microbiota. The trial will randomize 120 people in a 1:1 ratio to receive either TSO 7500 or placebo. Participants will receive six doses of TSO 7500 or placebo orally every other week over a 12-week treatment period. The trial will evaluate the effect of TSO on clinical response of UC, intestinal mucosal immunological response, and inflammatory markers. The primary endpoint will be the percentage of patients who achieve response (reduction of UCDAI of ≥ 3) by Week 12. The trial is planned to begin during the first quarter of 2013.