Date: 2014-06-26
Type of information: Results
phase: 1
Announcement: results
Company: Coronado Biosciences (USA)
Product: oral TSO (Trichuris suis ova or CNDO-201)
Action mechanism:
Disease: autism spectrum disorder
Therapeutic area: CNS diseases - Mental diseases - Neurodevelopmental diseases
Country: USA
Trial details:
Latest
news: * On June 26, 2014, Coronado Biosciences 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.
