CER-001 Atherosclerosis Regression ACS Trial

Subjects will be required to have at least one epicardial coronary artery suitable for IVUS
imaging. A suitable target artery for IVUS imaging will be determined at baseline as having
stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met
all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3
mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return
at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14
days after the last infusion. The total study duration from randomization to follow up IVUS
for a completed study can range from approximately 9 to 12 weeks.

Inclusion Criteria:

- Male or female greater than 18 years of age

- Acute coronary syndrome (myocardial infarction or unstable agina)

- Angiographic evidence of coronary artery disease with suitable "target" coronary
artery for IVUS evaluation

Exclusion Criteria:

- Females of child-bearing potential

- Angiographic evidence of >50% stenosis of the left main artery

- Uncontrolled diabetes (HbA1C>10%)

- Hypertriglyceridemia (>500 mg/dL)

- Congestive heart failure (NYHA class III or IV)

- Ejection fraction <35%

- Uncontrolled hypertension (SBP >180 mm Hg)

- Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine
dysfunction