New Autism drug in final stages of testing
NEW BRUNSWICK — Final testing of a new treatment for autism is taking place at Saint Peter's University Hospital.
"We are targeting the symptoms of autism," said Dr. Joan Fallon, founder of Curemark LLC., a drug-research and development company located in Rye, N.Y. The company is testing its new product at 13 locations nationwide.
The testing being conducted at Saint Peter's involves 170 youngsters, hospital spokesman Phil Hartman said.
Fallon said the test pool covers children age 3 to 8. She said she expects results "sometime early next year."
For competitive reasons, she did not want to discuss specifics of the product, called for now "CM-AT," for "Curemark's autism treatment."
She said the testing started about three months ago. Dr. Barbie Zimmerman-Bier of Saint Peter's, who is running the study, said, "Subjects heard about it and they got word from support groups...There was a screening process to see if they were eligible. They had to be between 3 and 8."
Regarding how children are being tested to see if the drug works and how frequently they are being checked, Fallon said, "We use standardized, validated measures to look at change in their behaviors."
Zimmerman-Bier reported said were seen at the beginning of the study, then at two weeks, four weeks, eight weeks and 12 weeks.
Curemark said in a release that, "CM-AT, which has received fast-track status from the FDA, is based on Curemark's research that showed enzyme deficiencies in autistic children, resulting in an inability to digest protein. The inability to digest protein affects the availability of amino acids, the building blocks of chemicals essential for brain function."
The release concluded, "If approved, CM-AT will be one of the first therapies to address the underlying physiology of autism."
Fallon said Saint Peter's was chosen because "They are a well-known center for autism," citing the work of Zimmerman-Bier, head of the developmental and behavioral pediatrics program at Saint Peter's Healthcare System.
"We do see a lot of children," Zimmerman-Bier said. "We don't know what the children are getting. It is a double-blind study."
"We have one of the most advanced testing methodologies in schools and in hospitals," said St. Peter's spokesman Hartman. "People actually relocate here to take advantage of the services available in New Jersey."