Curemark Enrolls First Patients In Phase III Clinical Trials For Autism Treatment

Main Category: Autism
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 15 Oct 2009 - 2:00 PDT

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Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that it has enrolled the first patients in Phase III clinical trials for its autism treatment, CM-AT. The first clinical trial patients have been enrolled at Lake Mary Pediatrics in Orange City, Florida, one of 12 clinical trial sites with a total 170 children across the country.

CM-AT is based on research by Curemark founder and CEO Dr. Joan Fallon 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.

"We are very excited to be enrolling our first children in the Phase III trials for CM-AT. Our progress with the clinical trials culminates years of research resulting in the breakthrough discovery of this therapy for children with autism," Fallon said. "We're hopeful that 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 study, 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.

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.

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