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CureMark IND for ADHD Granted by FDA


8/10/2010 10:17:38 AM

RYE, N.Y., Aug. 10 /PRNewswire/ -- Curemark, LLC (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has given clearance to Curemark's Investigational New Drug (IND) application for a Phase III clinical trial for the use of CM 4612 in the treatment of attention deficit hyperactivity disorder (ADHD).

Currently, Curemark is conducting Phase III clinical trials for CM-AT, its autism treatment targeted to enzyme deficiencies in autistic children. The lack of these enzymes affects the availability of amino acids, the building blocks of chemicals essential for brain function.

"We are very excited to have received IND clearance from the FDA so that we can move forward with clinical trials to study CM - 4612," said Dr. Joan Fallon, Curemark founder and CEO. "Curemark hopes to have the first physiologically-based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments."

According to statistics from the Centers for Disease Control and Prevention (CDC), 3% to 7% of school-aged children in the United States suffer from ADHD, accounting for an overall total of 4.5 million U.S. children.

Curemark is conducting Phase III clinical trials for its CM-AT autism treatment at 13 sites across the country with a total planned enrollment of 170 children. With regard to its regulatory filing program, CM-AT has received Fast Track review status from the FDA.

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



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