Curemark, LLC, Launches New Phase III Trial in Expanded Population of Children with Autism

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May 11, 2015, 09:00 ET

RYE, N.Y., May 11, 2015 /PRNewswire/ -- Curemark LLC, a privately held drug research and development company, announced the start of a new Phase III double blind, randomized, placebo-controlled clinical trial to examine the effect of its novel formulation, CM-AT, on all children ages 3-8 with Autism. Previously, Curemark announced the successful results of its FDA Phase III double blinded clinical trial for CM-AT in children ages 3-8 with Autism who had low levels of the digestive enzyme chymotrypsin. This new trial will help determine whether all children with Autism could potentially benefit from CM-AT.

Dr. Joan Fallon, Curemark Founder and CEO stated, "From the beginning, our goal has been to bring our proprietary Autism drug to as many children with the condition as possible. This trial has the potential to dramatically deepen our understanding around which children with Autism can benefit from CM-AT."

Curemark is currently submitting its rolling New Drug Application for CM-AT under the FDA's Fast Track designation. A Fast Track designation is designed to help facilitate the development and expedites the review of new drugs that are intended to treat serious or life-threatening conditions that demonstrate the potential to meet unmet medical needs.

The company is initiating this trial at 20 centers of excellence for Autism throughout the United States. "We have chosen some of the pre-eminent clinical sites and clinicians to conduct this clinical trial," states Dr. Matthew Heil, Curemark's Chief Scientific Officer.

For a current list of clinical sites please go to www.clinicaltrials.gov

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 previously announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for Autism met its primary and secondary endpoints. To learn more about our innovative science, visit www.curemark.com

Safe-Harbor Statements

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 the Curemark products CM-AT, CM-4612 and CM-182 their potential advantages, their potential for use in treating diseases or disorders, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning the Curemark products CM-AT, CM-4612 and CM-182. 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 the Curemark products CM-AT, CM-4612 and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182 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