Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome

1\. Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product.

2\. Patients who have had any major surgical procedure within 14 days of Day 1. BM biopsy is not considered a major surgical procedure.

3\. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is being treated on this trial.

4\. Seropositive for HIV antibodies (HIV1 and HIV2), Hepatitis C antibody (Hep C Ab) or a Hepatitis B carrier (positive for Hepatitis B surface antigen \[HBsAg\]).

5\. Life expectancy of ≤ 2 months. 6. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:

• Unstable cardiovascular conditions at Baseline including but not limited to:

* Symptomatic ischemia, or

* Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded); or

* Congestive heart failure (CHF) NYHA Class ≥ 3, or

* Myocardial infarction (MI) within 3 months. • Presence of active, uncontrolled infection. • Known central nervous system illness (e.g., Alzheimer's disease).

* A gastrointestinal disorder that may affect the absorption of study medication.

* Use of alcohol or drug use that may interfere with the patient's ability to participate in the study.

* Unstable psychiatric disorder that would render the patient unable to comply with study requirements.

* Any malignancies in the 3 years prior to Baseline, excluding basal cell carcinoma, in situ malignancy, low-risk prostate cancer, cervical cancer after curative therapy.

* A co-morbid condition that, in the Investigator's opinion, renders the subject at high risk for treatment complications.

7\. Unable to comply with study requirements in the opinion of the Investigator.

What this study is about