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


Phase 2 Results

Eligibility Criteria

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