NEW YORK, Aug. 6, 2012 /PRNewswire/ -- Dr. Joan Fallon, founder and CEO of Curemark, a Rye, New York-based drug research and development company focused on the treatment of Autism and neurological diseases, today announced that the company has received clearance from the Food and Drug Administration (FDA) to commence direct enrollment of children 9-12 years of age into its open-label extension study of CM-AT for children with Autism. A limited cohort of children and sites will be involved in this direct enrollment.
In December 2011, Curemark reported that its Phase III double-blind randomized placebo-controlled multicenter clinical trial of CM-AT for Autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with Autism 3-8 years of age. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both the core and non-core symptoms of Autism.
Dr. Fallon stated, "We are thrilled to be allowed to directly enroll these older children into our ongoing open-label extension study." She continued, "Enrolling children 9-12 years-of-age with Autism who may potentially benefit from this therapeutic treatment in our trial is extremely important."
The FDA has placed CM-AT into the Fast Track program which facilitates the development and expedites the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
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 announced in December, 2011, 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.
Autism Spectrum Disorder (ASD) is a range of complex neurodevelopment disorders characterized by social impairments, communication difficulties, and restricted, repetitive, and stereotyped patterns of behavior. It is estimated that autism affects 1 in 88 children in the United States. It is reported to occur in all racial, ethnic and socioeconomic groups, with a 3 to 4 times greater occurrence in boys than girls. There is presently no drug approved to treat the core symptoms of autism. Recent studies have estimated that the lifetime cost to care for an individual with an ASD is $3.2 million.
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 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