BURLINGTON, MA, USA I June 26, 2014 I Coronado Biosciences, Inc. (CNDO) today announced that Dr. Eric Hollander, Clinical Professor 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 has completed his pilot study of oral TSO (Trichuris suis ova or CNDO-201) for adults with Autism Spectrum Disorder (ASD).

The study was 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.

While none of the measures reached statistical significance, benefits with TSO treatment (over placebo) were observed in several subscales, including the Montefiore-Einstein Rigidity Scale (MERS), ABC Irritability, RBS-R Sameness, and RBS-R Restricted Behavior. TSO was well-tolerated; no patient discontinued due to an adverse event (or due to tolerability issues), and 9 of 10 patients completed the full 26 week treatment period. Detailed data will be presented at the European College of Neuropsychopharmacology (ECNP) Congress in October 2014.

Dr. Hollander commented, “This hypothesis-generating pilot data is supportive of additional studies with TSO in younger ASD populations with greater irritability.”

About Autism Spectrum Disorder

Autism spectrum disorder and autism are both general terms for a group of complex disorders of brain development. These disorders are characterized by three core symptoms: difficulties in social interaction, verbal and nonverbal communication and repetitive behaviors. Autism statistics from the U.S. Centers for Disease Control and Prevention identify approximately 1 in 68 American children as on the autism spectrum. Autism Speaks, the world’s leading autism science and advocacy organization, announced in March 2012 preliminary results of new research that estimates autism costs society $126 billion per year in the U.S.

About Coronado Biosciences

Since inception, Coronado Biosciences has been a biopharmaceutical company involved in the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, namely CNDO-201 or Trichuris suis ova (TSO) and CNDO-109. As part of its growth strategy, the Company plans to identify, evaluate and potentially in-license, acquire or invest in pharmaceutical and biotechnology products, technologies and/or companies. Coronado may also from time to time consider financing existing or later-acquired products, technologies or companies through partnerships, joint ventures, direct financings and/or public or private spin-outs.

SOURCE: Coronado Biosciences