Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS

Inclusion Criteria

• •1. Provide informed consent
• •2. ≥ 18 years of age
• •3. Phase 1 (dose escalation) subjects must have either:
• •* AML that has failed to achieve complete remission or morphologic complete remission or
• •* MDS - Marrow blasts must be \> 5% and disease failed at least 1 prior hypomethylating agent
• •4. Phase 2 (expansion) subjects must have either MDS or relapsed/refractory AML
• •5. Eastern Cooperative Oncology Group performance status 0, 1, or 2
• •6. Total bilirubin ≤ 2
• •7. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times upper limit of normal (ULN)
• •8. Serum creatinine \< 2.5 times ULN
• •9. Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
• •10. Women of child-bearing potential
• •11. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods