Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

With prior approval by the FDA, an interim analysis for futility was performed when 500
subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The
analyses were reviewed by the data safety monitoring board, which recommended that both
studies be terminated because of futility. This was done at a point where 650 subjects had
been entered into both studies, combined, but analyses were conducted only on the initial 500
subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that
study contributed most of the subjects to the analysis.

Inclusion Criteria:

- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment

- Baseline NIHSS > 5

Exclusion Criteria:

- No intracranial, extravascular blood on CT

- Hypertension (systolic > 185; diastolic > 105)

- Baseline fibrinogen level < 100 mg/dL

- Thrombocytopenia (< 100,000 / mm3)

- Recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent

- Recent (< 14 days) or anticipated surgery