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

A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)

The purpose of this study is:

• To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
• To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.

Inclusion Criteria:

• Age 18-85
• NIHSS score 8-20
• Stroke is ischemic in origin, supratentorial, and radiologically confirmed
• Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
• Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
• Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
• Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

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