May 11, 2010

UC Davis’ MIND Institute will test an autism drug fast-tracked by the U.S. Food and Drug Administration in a phase III clinical trial by Curemark LLC of Rye, N.Y.

Curemark has developed CM-AT, a drug candidate to treat enzyme deficiencies in autistic children. Curemark founder Joan Fallon has been doing research since 1999 to show that autistic children with enzyme deficiencies can’t digest protein. That affects the production of amino acids, which are necessary for forming the chemicals vital to brain function.

“It’s a unique approach,” Fallon said. She said the drugs currently used to treat autism are used to treat the aggression associated with the disorder not the core symptoms. “We’re looking to treat the core symptoms,” she said. Part of the company's funding comes from angel investors.

Curemark has 12 centers throughout the country actively signing up patients in the trial. The goal is to have 170 children participate. The MIND institute plans to enroll 10 autism patients aged three to eight years old. The 12-week study is due to begin in a few weeks.

Fallon expects the trial to last a little more than a year. The FDA has fast-tracked the drug meaning that once the trial is complete, and if the data is acceptable, the agency agrees to accelerate the approval process, usually within six months, Fallon said. That means CM-AT could be on the market by the end of 2011 or the beginning of 2012 if all goes as planned.

The U.S. Center for Disease Control released information in October 2009 on a study it did showing that autism affects 1 in 91 children and 1 in 58 boys for a total of 673,000 or about 1 percent of all children in the U.S.

The MIND institute began with six families struggling with autism. It is now a research leader in autism and other neurodevelopmental disorders. It is a partnership of experts in neuroscience, education, immunology, genetics, molecular biology, psychology and developmental pediatrics.