A Trial of CM-AT in Children With Autism- Open Label Extension Study

Autism is currently a significant cause of disability in the pediatric population. CM-AT is
based upon the observation that many children with autism do not digest protein. CM-AT is a
proprietary enzyme that is designed as a powder taken three times a day. It is formulated to
be released in the small intestine to enhance protein digestion thus increasing the
availability of essential amino acids.

Inclusion Criteria:

- Meets the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR)
diagnostic criteria for autistic disorder (AD)

- Ongoing 00102 Protocol required completion of 00101 Protocol

- Now recruiting subjects directly into 00102 Protocol

Exclusion Criteria:

- Ongoing study required patients to be 3-8 years old weighing < 11kg (24.2 lbs.), and
achieving ages 9-12 years old weighing < 22kg (48.4 lbs.).

- Newly recruited subjects must be between ages 9 - 12 years old weighing < 22kgs (48.4
lbs.)

- Demonstrated previous allergy to porcine (pork) products

- Previous history of severe head trauma or stroke, seizure within one year of entering
study or uncontrolled systemic disease

- Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease

- Within 30 days of starting the study, certain supplementation, chelation or dietary
restriction (a 30 day washout period would be required for inclusion)

- Any use of psychotropic medications, stimulants, or SSRI's must be discontinued for 30
days prior to entrance