YONKERS, N.Y., Dec. 14 /PRNewswire/ -- CureMark, a new drug development company focused on neurological conditions with an emphasis in dysautonomia, reports positive results from a pre-IND meeting with the FDA. The meeting was held to discuss their proprietary enzyme formulation and its application for children with ADD, ADHD and autism.
“We have a clear path to do clinical trials as outlined during the meeting, and will file an IND during the first quarter of 2006,” states Dr. Joan M. Fallon, CEO of CureMark. “We are quite excited to have been received so well, and look forward to working through the process with the FDA and commencing clinical trials during 2006.”
Children with ADD, ADHD and autism have been found to lack the ability to digest protein. Faulty metabolism or deficiencies in the ability to digest protein will ultimately result in a dearth of amino acids. These amino acids play a key role in the building of other proteins such as neurotransmitters which are necessary for the body to function optimally. The lack of protein digestion can result from either an inherent inability or as a result of an insult such as that which is experienced by children with regressive autism.
CureMark has done extensive preclinical work and has multiple patents issued and pending surrounding their technology, including multiple-use patents for enzyme technology. Due to the nature of the enzyme’s ability to make changes in the behaviors of children with ADD, ADHD, and autism as demonstrated by their preclinical trial work, CureMark has outlined clinical trials which will examine multiple endpoints including behavioral, quality-of- life, as well as physiological parameters.
“This is an exciting time for CureMark,” states Dr. Fallon. “Our patent position allows us to either move forward on our own to perform clinical trials, or to partner with another drug development or enzyme company.”
Contact: Dr. Joan M. Fallon, CEO CureMark 914-779-9300
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CureMark
CONTACT: Dr. Joan M. Fallon, CEO of CureMark, +1-914-779-9300