Curemark Completes Enrollment of Phase III Autism Trials

News provided by

Mar 21, 2011, 09:23 ET

RYE, N.Y., March 21, 2011 /PRNewswire/ -- Curemark, LLC, (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the company has completed its targeted enrollment of Phase III clinical trials for CM-AT, its autism treatment.

Curemark has reached its targeted enrollment for the study of a total 170 children, who are participating in the CM-AT Phase III trial at 18 sites across the country.

"We have been extremely pleased with the enthusiastic response of our clinical sites during the CM-AT Phase III trial process. We now have the full complement of trial participants and will close the trial to enrollment and begin the compilation process for FDA submissions," stated Dr. Bill Gannon, Curemark's Medical Director.

"This marks a significant milestone for us and our research program," said Dr. Joan Fallon, Curemark founder and CEO. "We are grateful to our clinical sites for their participation."

CM-AT targets enzyme deficiencies in autistic children. These deficiencies affect the availability of amino acids, the building blocks of chemicals that are essential for brain function. Curemark's autism therapy 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