Curemark Opens Patient Enrollment for Autism Treatment at Three More Clinical Trial Sites

RYE, N.Y., Nov. 19 /PRNewswire/ -- <!-- cpurl -->Curemark <!-- /cpurl --> LLC, (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the company has begun enrolling patients in Phase III clinical trials for <!-- ppurl -->CM-AT <!-- /ppurl -->, its autism treatment, at three additional clinical trial sites. The sites are the Southwest Autism and Resource Center in Phoenix, Arizona (SARRC); Pennsylvania State University's Pediatric Clinical Research Office at Hershey Medical Center in Hershey Pennsylvania; and the University of North Carolina at Chapel Hill.
 

Curemark is conducting Phase III clinical trials for CM-AT at 12 sites with a total 170 children across the country. The company previously announced that the first clinical trial patients were enrolled at Lake Mary Pediatrics in Orange City, Florida.
 

"We are extremely pleased with the progress of the Phase III trial enrollment for CM-AT and are continuing to move forward with the other sites in the study across the country," said Dr. Joan Fallon, Curemark founder and CEO. "Especially given the new data on the increased incidence of autism, we're excited to be this far along in our clinical program."
 

CM-AT is based on Fallon's 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.
 

A new study released in early October by the U.S. Centers for Disease Control (CDC) showed that the number of children affected by autism is much higher than originally thought. According to the CDC, autism affects 1 in 91 children and about 1 in 58 boys, totaling an estimated 673,000 or approximately 1% of all children in the U.S.
 

For information on participating in the 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

CONTACT: Michelle Manoff, Rubenstein Public Relations, +1-212-843-8051,
mmanoff@rubensteinpr.com; or Dr. Joan Fallon, Curemark LLC, +1-914-925-3450,
joan.fallon@curemark.com
 

Posted: November 2009

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