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OPEN MINDS Online News: FDA Puts Curemark CM-AT Autism Treatment on Fast Track
Monday, March 15th - 2010
On February 22, 2010, Curemark LLC announced that the U.S. Food and Drug Administration (FDA) designated its CM-AT autism treatment as a Fast Track medication. The treatment—orally ingested protease powder—addresses an enzyme deficiency common to children with autism that results in an inability to digest protein, which then impairs the production of amino acids necessary for normal brain function. The protease helps digest protein. Phase III clinical trials of CM-AT enzyme therapy are enrolling patients at 10 sites; a total of 12 sites will provide the treatment to 170 children. The FDA Fast Track status expedites the FDA review process of treatments for serious conditions with no existing therapy, or for medications that are potentially superior to an existing therapy.
Curemark is a drug research and development company focused on the treatment of neurological disorders, especially those with dysautonomic components such as autism, attention deficit/hyperactivity disorder, cystic fibrosis, or Parkinson’s disease, by addressing deficiencies in certain key gastrointestinal/pancreatic secretions. The FDA approved Curemark’s Investigational New Drug application to start the Phase III trials in March 2009. The company’s initial products are based on research by founder and chief executive officer, Joan Fallon, which detected that children with autism and attention deficit/hyperactivity disorder did not properly digest proteins.
For more information, contact: Dr. Joan Fallon, Founder and Chief Executive Officer, Curemark, LLC., 411 Theodore Fremd Avenue, Suite 206 S, Rye, New York 10580; 914-925-3450; E-mail: info@curemark.com; Web site: www.curemark.com
