Curemark Receives Investigational New Drug Clearance for CM-AT ... ( Phase III Trial to Begin RYE N...)

Curemark Receives Investigational New Drug Clearance for CM-AT for Autism

Date:3/25/2009

Phase III Trial to Begin

RYE, N.Y., March 25 /PRNewswire/ -- Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to initiate its pivotal Phase III clinical trial of CM-AT for the treatment of autism.

The company expects to begin Phase III clinical trials at multiple sites across the US in the second quarter of 2009. As part of this IND, the FDA has agreed that Curemark may proceed directly into pivotal Phase III clinical trials in patients with autism. The FDA has reviewed the quality, safety and efficacy data generated by Curemark in pediatric patients with autism. In addition, the FDA has provided written guidance on the trial protocol.

"FDA clearance of the CM-AT IND for the pivotal Phase III trial is an important milestone for Curemark," commented Dr. Joan Fallon, Curemark's CEO. "With 1 in 150 children diagnosed with autism, we have children who are suffering. We are very excited about the opportunity to enter a Phase III trial for this ever-growing population of children."

About CM-AT

As part of Curemark's ENCAPTASE(TM) technology platform, CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary therapy formulated to be released in the small intestine of children with autism. Designed as an easily utilized powder taken three times a day, CM-AT was developed with the children in the forefront. The administration of CM-AT with meals allows for an increase in protein digestion thus potentially reducing allergy and increasing the availability of essential amino acids. With proper protein digestion in a subset of children with autism, the need for protein restricted diets, such as gluten-free and casein-free diets, to which many ch
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