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news.US-based Coronado Biosciences (CNDO) has started an investigator-initiated trial evaluating TSO (Trichuris suis ova or CNDO-201) for the treatment of pediatric patients with autism spectrum disorder (ASD).
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The trial is being carried out at the Hadassah-Hebrew University Medical Center in Jerusalem, Israel by Dr. Itai Berger, director of Neuro-Cognitive Center, and the principal investigator of the trial.
Coronado chairman, president and CEO Lindsay Rosenwald said there is increasing evidence linking immune dysregulation to autism in a subset of patients.
"Whether an approach like TSO can modify the disease course of ASD is an important scientific and clinical question," Rosenwald said.
"We are very pleased that Dr. Berger has decided to conduct the first TSO study in pediatric ASD patients."
About 60 patients in the age range of 6 to 17 years who meet criteria for the diagnosis of ASD, will be enrolled in the 16-week randomized, double-blind, placebo-controlled trial.
In the trial, patients will receive placebo, 2500 TSO or 7500 TSO every other week for 16 weeks.
The trial is aimed at testing the safety of TSO compared to placebo in pediatric patients with ASD, and efficacy signals on irritability, repetitive behaviors, global functioning and social cognition.