Curemark, LLC, the drug company known for researching and developing treatment for neurological diseases has announced Phase III clinical trials for its autism treatment, CM-AT.
According to the Curemark website, they describe CM-AT 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. Curemark has identified a series of biomarkers that determine which children with autism and PDD may have digestive deficiencies underlying or as a major component of their disease.
Curemark has carried out an extensive clinical analysis to identify the role of secretory malfunctions of the pancreas and/or gastrointestinal tract as they may be linked to the severe behaviors seen in children with autism. In office based trials, Dr. Fallon and associates have treated a large number of children with positive results and has catalogued their treatment in over 500 children.
CM-AT is a proprietary therapy formulated to be released in the small intestine of children with autism. Designed as an easily utilized powder (sachet). CM-AT was developed with the children in the forefront.
According to a Reuters article, the first patients in the clinical trial 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."
Interested in participating? They are looking for subjects between 3 and 8 years old and who meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for autistic disorder (AD).
For more information log on to www.clinicaltrials.gov and search "Curemark."
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