Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

Exclusion Criteria

• •Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
• •Patients who have received tissue plasminogen activator (tPA)following the index stroke
• •Patients classified as comatose
• •Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
• •Serum hemoglobin \> 16 grams(g)/deciliter (dL)(males) or \> 14 g/dL (females); or platelet count \> 400,000/cubic millimeters(mm3)
• •Advanced liver, kidney, cardiac, or pulmonary disease
• •Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
• •Patients with a known history of hypercoagulability
• •Expected survival \< 1 year
• •Allergy or other contraindication to hCG or EPO
• •A known diagnosis of cancer in the previous 5 years
• •Uncontrolled hypertension
• •Use of either hCG or epoetin alfa within the previous 90 days
• •Any condition known to elevate hCG
• •Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
• •Any patients not living independently
• •Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
• •With the exception of the qualifying stroke, any other stroke within the previous 3 months
• •Patients who cannot take anti-platelet or anti-coagulant therapy
• •Pre-existing and active major psychiatric or other chronic neurological disease
• •Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
• •Currently participating in another investigational study