Phase III Trial to Begin
RYE, N.Y., March 25 /PRNewswire/ -- Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to initiate its pivotal Phase III clinical trial of CM-AT for the treatment of autism.
The company expects to begin Phase III clinical trials at multiple sites across the US in the second quarter of 2009. As part of this IND, the FDA has agreed that Curemark may proceed directly into pivotal Phase III clinical trials in patients with autism. The FDA has reviewed the quality, safety and efficacy data generated by Curemark in pediatric patients with autism. In addition, the FDA has provided written guidance on the trial protocol.
"FDA clearance of the CM-AT IND for the pivotal Phase III trial is an important milestone for Curemark," commented Dr. Joan Fallon, Curemark's CEO. "With 1 in 150 children diagnosed with autism, we have children who are suffering. We are very excited about the opportunity to enter a Phase III trial for this ever-growing population of children."
As part of Curemark's ENCAPTASE(TM) technology platform, CM-AT is based upon the observation that many children with autism do not digest protein. CM-AT is a proprietary therapy formulated to be released in the small intestine of children with autism. Designed as an easily utilized powder taken three times a day, CM-AT was developed with the children in the forefront. The administration of CM-AT with meals allows for an increase in protein digestion thus potentially reducing allergy and increasing the availability of essential amino acids. With proper protein digestion in a subset of children with autism, the need for protein restricted diets, such as gluten-free and casein-free diets, to which many children with autism have become accustomed, may no longer be necessary. Being able to digest protein rather than avoid it will allow children with autism greater access to the building blocks for the manufacture of new proteins such as neurotransmitters. A partial or complete lack of protein digestion could further lead to other gastrointestinal and digestive dysfunctions.
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
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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