New Study Will Test Theory That Enzyme Contributes to Autism

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New Study Will Test Theory That Enzyme Contributes to Autism

The debate rages on both the causes and “cures” for autism. There is the

mercury-vaccination contingent, the gluten-free, casein-free diet supporters,

those that believe genetics play a role, and the list goes on. There may very

well be multiple etiologies for this developmental disorder, and research

continues throughout the world to determine, definitively and finally, what that

is.

One of the newest clinical trials is just beginning across the country, at

fifteen institutions, including the University of California at San Francisco.

Funded by Curemark, a New York-based drug company, this Phase III clinical trial

for CM-AT autism treatment, has been granted fast track status by the FDA.

Researchers will be testing whether certain children with autism can benefit

from regular doses of an enzyme to help them digest proteins, which may in turn

improve their brain function and ease some symptoms of autism.

The trial is not without its naysayers. There is very little research to support

the premise that a missing enzyme is a factor in the cause of autism. There are

those studies which have shown that a small subset of children diagnosed with

autism have enzyme deficiencies, but there is debate as to whether it is a

causation or a symptom of the disorder. But with a new case of autism being

diagnosed every 20 minutes in America, it is imperative that research such as

this be conducted. Sometimes, with a bit of persistence and creative thinking,

you do find that needle in a haystack.

The trial will involve 170 children, ages three to eight, over a 90-day period.

Half of the participants will be a control group and receive a placebo, while

the other half will receive three enzyme treatments per day (a tasteless powder

sprinkled over food). At the end of the 90 days, parents can remove their

children entirely from the project or choose to continue for one year on the

enzyme regimen.

" The treatment is enormously simple, but finding it out wasn't simple at all, "

said Joan Fallon, chief executive of Curemark. " Is it theoretical? Yes. But we

hope the trials will give some benefit to a subgroup of children. And we hope

our trials will make other researchers look at the physiology of the disorder. "

Curemark has identified a series of biomarkers that determine which children

with autism and Pervasive Developmental Disorder (PDD) may have digestive

deficiencies underlying or as a major component of their disease. Research by

Dr. Fallon showed enzyme deficiencies in children with autism, 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.

Autism is a neurological and biological disorder which typically affects

children ages 18 months to 5 years of age. It knows no racial, ethnic or social

boundaries. A child’s chances of having autism are not determined by their

family’s lifestyle, education or income.