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

Inclusion criteria

• ✓. Adult men and women aged 18 and older
• ✓. Patient must have the ability to understand the requirements of the study and provide informed consent.
• ✓. Patients with the diagnosis of severe AA, who are not currently candidates for an allogeneic stem cell transplant, fulfilling the following criteria:
• ✓. BM cellularity \< 30% and
• ✓. Peripheral blood (PB) showing at least two of the following criteria:
• ✓. Patients with recurrent/relapsed AA will be eligible for the trial as long as they were not previously refractory to hATG-based therapy and the relapse occurred \> 3 months after response.
• ✓. Patients with Hypoplastic MDS defined as MDS with marrow cellularity of:
• ✓. Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy, including standard and investigational treatments for AA, for at least 1 week or 5 half-lives whichever comes later, prior to entering this study, and have recovered from the toxic effects of that therapy to Grade 1 or less.