Curemark LLC Reports Positive Phase III Results of CM-AT in Children With Autism
RYE, N.Y., Dec. 7, 2011 /PRNewswire/ -- Curemark LLC, a Rye, New York-based drug research and development company, today announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with autism aged 3 – 8. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both core and non-core symptoms of autism. Analysis of the full trial data is ongoing and the results will be presented at an upcoming medical meeting.
"We are extremely pleased with the results of our trial," said Dr. Joan Fallon, CEO of Curemark. "We wish to thank all the children and their parents who participated in the study, and look forward to a full review of the data by the FDA."
CM-AT has been granted Fast Track status by the Food and Drug Administration (FDA). The fast track programs of the Food and Drug Administration are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
About Curemark LLC
Curemark is a drug research and development company focused on the treatment of neurological and other diseases, especially those with dysautonomic components, by addressing certain key gastrointestinal/pancreatic secretory deficiencies. The company's initial products are based upon breakthrough observations by its founder, Dr. Joan Fallon, which revealed a lack of protein digestion in children with autism and ADHD. In addition to CM-AT for autism, Curemark has two more drugs in development. These are CM-4612 for Attention Deficit Hyperactivity Disorder (ADHD), for which the company has open Investigational New Drug (IND) clearance to conduct Phase III trials, and