A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

Inclusion Criteria:

- Willing and able to provide informed consent

- Age 18 and older

- Diagnosis of AML or MDS according to the WHO criteria

- AML relapsed or refractory to at least one attempt at induction or subjects not
candidates for aggressive induction regimens

- MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS
following a response to an HMA

- Has adequate organ function: AST and ALT < 3X the ULN, serum bilirubin < 2X the ULN,
serum creatinine of < 2 mg/dL, or a calculated creatinine clearance of > 50 mL/minute

- ECOG Performance Score of 0 -2

- Recovered from the effects of any prior systemic therapy, radiotherapy or surgery

- Willing to use physician approved birth control method

Exclusion Criteria:

- Current CNS Leukemia

- Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality
or Bcr/Abl positive leukemia

- < 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires
continued treatment with systemic immunosuppressive agents

- Uncontrolled infection

- Known HIV, hepatitis B or hepatitis C.

- Other active malignancy that requires therapy

- If female, is lactating or breast feeding

- Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)