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Tuesday
Apr242012

Coronado Biosciences receives recommendation to continue Falk phase 2 trial of TSO in Crohn's disease

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 received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suisova (TSO) in Crohn's disease. The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue. See the full release @

http://www.proactivenewsroom.com/Blog/bid/85980/Coronado-Biosciences-Announces-Independent-Data-Monitoring-Committee-Recommendation-to-Continue-Falk-Phase-2-Trial-of-TSO-in-Crohn-s-Disease

Daily Dose Updates:

  • CNDO received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease.
  • The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue.
  • Falk has advised they are adopting the committee's recommendations to increase the sample size and to conduct a subsequent interim analysis at the time the trial reaches approximately 250 patients.
  • The Falk trial, entitled Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn's disease, is being conducted in Europe and was initially expected to enroll approximately 212 patients and to evaluate three different dosages of TSO versus placebo.

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