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Thursday, 12/12/2013 4:38:00 PM

Thursday, December 12, 2013 4:38:00 PM

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Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting
GlobeNewswire Coronado Biosciences, Inc.
4 minutes ago
Study Investigator Eric Hollander, M.D., Reports Potential Benefits of TSO Immunotherapy in First 5 Patients
Study Completion and Final Results Expected Mid-2014
BURLINGTON, Mass., Dec. 12, 2013 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (CNDO), a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.

The study is a double-blind, randomized, placebo-controlled, cross-over study and enrolled 10 high-functioning adult autism spectrum disorder patients who were able to give informed consent to participate in the study and who had a history of allergies and/or a family history of immune-inflammatory illness. They were treated for 12 weeks with either TSO or placebo, followed by a 4-week washout phase and then 12 weeks of placebo or TSO. The TSO dosage used in the study was 2,500 ova once every two weeks.

In the first 5 patients that completed the study, there was a statistically significant separation from placebo in favor of TSO on three measures of disease: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The treatment was well tolerated.

The study is still ongoing and final results are expected in the middle of 2014.

"There is increasing evidence that immune dysregulation plays an important role in this developmental disorder and we are encouraged by the interim data from this pilot study with TSO," said Dr. Harlan F. Weisman, Coronado's Chairman and CEO. "We believe autism is an area of unmet medical need where a natural immune system regulator like TSO may help a part of the autism population."

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