Coronado Biosciences Announces Independent Data Monitoring Committee Recommendation to Discontinue Falk Phase 2 Trial of TSO in Crohn's Disease

BURLINGTON, Mass., Nov. 7, 2013 (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, today announced that it has been informed by Dr. Falk Pharma GmbH (Falk), its development partner, that an Independent Data Monitoring Committee (IDMC) has conducted a second interim analysis of clinical data from approximately 240 patients who have completed 12 weeks of treatment in Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease. The committee recommended that the trial be stopped due to lack of efficacy and noted no safety concerns. Falk has advised Coronado that it is adopting the committee's recommendations and discontinuing the study.

"We are not surprised by these results, given the disappointing data from our TRUST-I study," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe TSO has therapeutic potential in other diseases and will continue to work diligently to advance its development for the treatment of autoimmune diseases and to develop CNDO-109 for the treatment of cancer."

The Falk trial, also known as the TRUST-II study, is a double-blind, randomized, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of three different dosages of oral TSO in patients with active Crohn's disease. The purpose of the interim analysis was to verify the assumptions of the sample size calculation or to recalculate sample size based on the effect size estimations of the interim analysis and determine whether to discontinue the study due to futility.

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors. For more information, please visit

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CONTACT: Lucy Lu, MD, Executive Vice President & 
         Chief Financial Officer 
         Coronado Biosciences, Inc. 
         781-652-4525; [email protected]