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CureMark Reports Positive Phase III Results of CM-AT in Children With Autism



12/7/2011 7:22:36 AM

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 CM-182 for schizophrenia. In addition, Curemark has in development a patented biomarker for Parkinson's disease. To learn more about the company's innovative science, visit www.curemark.com

About Autism

Autism Spectrum Disorder (ASD) is a range of complex neurodevelopment disorders characterized by social impairments, communication difficulties, and restricted, repetitive, and stereotyped patterns of behavior. It is estimated that autism affects 1 in 110 children in the United States. It is reported to occur in all racial, ethnic and socioeconomic groups, with a 4 to 5 times greater occurrence in boys than girls. It occurs worldwide, with reports of over 2.6% prevalence in Korea, and a 0.5-1% prevalence in other countries in Asia and Europe. There is presently no drug approved to treat the core symptoms of autism. Recent studies have estimated that the lifetime cost to care for an individual with an ASD is $3.2 million.

Safe Harbor Statement

This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of the Curemark products CM-AT, CM-4612 and CM-182 their potential advantages, their potential for use in treating diseases or disorders, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning the Curemark products CM-AT, CM-4612 and CM-182. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the Curemark products CM-AT, CM-4612 and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182 regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.

SOURCE Curemark LLC


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