An Open Label Study of CM-AT for the Treatment of Children With Autism

Autism is clearly a significant cause of disability in the pediatric population. Treatment is
based on the observation that many children with autism do not digest protein. CM-AT is a
proprietary enzyme that is designed as a granulated powder taken three times daily.

Inclusion Criteria:

- Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent
in Sponsor 00103 Study

- Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements

- Currently in the 00102 open label study and continue to meet eligibility requirements

- Subjects who initially qualified for 00103 screening, who subsequently failed Baseline
entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC
eligibility requirement who continue to meet eligibility requirements

- Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the
current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic
criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R

Exclusion Criteria:

- Patient weighing < 13kg

- Allergy to porcine products

- Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase

- History of severe head trauma, as defined by loss of consciousness or hospitalization,
skull fracture or stroke.

- Seizure within the last year prior to enrollment, or the need for seizure medications
either at present or in the past.

- Evidence or history of severe, moderate or uncontrolled systemic disease

- Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose
free is allowable but not dairy free.

- Inability to ingest the study drug / non-compliance with dosing schedule.

- Inability to follow the prescribed dosing schedule.

- Use of any stimulant or non-stimulant medication or medications given for attention
deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial
randomized study period.

- Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable
dose for a minimum of 30 days prior to entering the study.

- History of premature birth <35 weeks gestation.

- Prior history of stroke in utero or other in utero insult.