Curemark Enrolling Patients In Phase III Autism Trials At Ten Sites

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Jan 25, 2010, 10:03 ET

RYE, N.Y., Jan. 25 /PRNewswire/ -- Curemark, LLC, (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the company is now enrolling patients in Phase III clinical trials for CM-AT, its autism treatment, at ten sites across the country. The sites are:

Mount Sinai School of Medicine, New York City
Drexel University, Philadelphia
University of Texas, Houston
Indiana University, Purdue University, Indianapolis
Ohio State University, Columbus
Louisiana State University, Shreveport
Southwest Autism Research and Resource Center (SARRC), Phoenix, Arizona
University of North Carolina, Chapel Hill
Pennsylvania State University, Hershey Medical Center, Hershey, Pennsylvania
Lake Mary Pediatrics, Orange City, Florida

Curemark's Phase III trials for CM-AT encompass 12 sites nationally with a total 170 children.

"We have six new trial sites that are now active and recruiting patients – New York, Philadelphia, Houston, Indianapolis, Columbus and Shreveport. These are in addition to the four that we announced had opened enrollment in October and November," said Dr. Joan Fallon, Curemark founder and CEO. "We're moving very rapidly with our clinical trial program and anticipate that the remaining sites will be initiating enrollment soon."

CM-AT is based on breakthrough research that showed enzyme deficiencies in autistic children, resulting in an inability to digest protein. The inability to digest protein affects the production of amino acids, the building blocks of chemicals essential for brain function. CM-AT will be one of the first therapies to address the underlying physiology of autism, rather than just treat its symptoms.

"We're hopeful about the viability of Curemark's enzyme replacement therapy and the promise of CM-AT in targeting the physiology of autism for the first time," Fallon said.

New data released in December by the U.S. Centers for Disease Control and Prevention (CDC) indicated that the number of children affected by autism is higher than originally thought. According to the CDC, autism affects 1 in 110 children.

For information on participating in the Curemark CM-AT autism trials, log on to www.clinicaltrials.gov and search "Curemark."

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. To learn more about our innovative science, visit www.curemark.com

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 CM-AT, its potential advantages, its potential for use in treating autism, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning CM-AT. 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 CM-AT, our ability to finance our development of CM-AT, 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