07.11.2013 15:36:32

Coronado: IDMC Recommends To Stop Falk Phase 2 Trial Of TSO In Crohn's Disease

(RTTNews) - Coronado Biosciences Inc. (CNDO) announced Thursday that it has been informed by Dr. Falk Pharma GmbH, its development partner, that an Independent Data Monitoring Committee or 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 or 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 informed 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....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," said Dr. Harlan Weisman, Coronado's Chairman and CEO.

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.

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