Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours

Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic,
caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic
drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke
approved by the FDA. Treatment with tPA must be administered within three hours of the stroke
onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602
is an investigational drug that may act as a neuroprotectant in patients who have had a
stroke. It is thought to stop cell death and reduce inflammation in the injured area of the
brain. This study is designed to evaluate the safety and efficacy of GM602 administered
intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the
initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle
Cerebral artery region.

Inclusion Criteria:

- > 18 years old

- Be eligible for MRI or CT scan

- Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution,
as verified by the Screening DWI abnormality and Screening PWI abnormality

- Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening

- Have suffered acute ischemic stroke within 18 hours

- Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior
to suffering stroke

- Patients who received tPA or FDA approved mechanical device can also enroll

- completed informed consent form

Exclusion Criteria:

- Have history of stroke in the past 3 months

- Cannot be evaluated using MRI/CT

- Have stroke of the brainstem or cerebellum

- Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at
screening

- Have hemorrhage revealed by CT or MRI scan

- Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO
intensity as seen on CT

- Have blood sugar level >400 mg/DL or<50 mg/dL

- Have kidney disease, creatinine > 2.0

- Have had recent (within 90 days) serious head trauma or head trauma with loss of
consciousness

- Have any prior history of seizure

- Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥
2)

- Have any other known clinically significant medical disorder (cardiovascular, hepatic,
renal, endocrine, respiratory, immunological, cancer, AIDS)

- Life expectancy of less than 6 months due to comorbid conditions

- Women of child bearing potential who are pregnant or breast-feeding or unable to
practice birth control during the study period

- Have participated in any other trial of an investigational agent within 90 days prior
to screening

- Informed consent cannot be obtained

- Unable to participate in study visits