Curemark CM-AT Autism Treatment Granted FDA Fast Track Status

News provided by

Feb 22, 2010, 09:55 ET

RYE, N.Y., Feb. 22 /PRNewswire/ -- Curemark LLC, (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that its CM-AT autism treatment, now in Phase III clinical trials, has been designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA).

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and those that fill an unmet medical need, providing a therapy where none exists or are potentially superior to existing therapy, according to the FDA Web site. Fast Track designation provides for early and frequent communication between the FDA and the drug company to resolve questions and issues quickly, obtaining an expedited review and faster access by patients.

"We are very excited about the FDA's Fast Track designation for CM-AT," said Dr. Joan Fallon, Curemark founder and CEO. "We're making rapid progress with the CM-AT trials and being named as a Fast Track drug means that we potentially can get our autism treatment to market faster for the children and parents who will benefit from it."

CM-AT is based on Dr. 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.

Curemark is conducting Phase III clinical trials for CM-AT at 12 sites across the country with a total 170 children. Ten of the sites are now enrolling patients.

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 about 1 in 110 children.

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