Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of MDS

- Adequate liver and kidney function

- Ineligible for, or refusing, allogeneic bone marrow transplant

- At least 18 years of age

- Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study
entry

Exclusion Criteria:

- Failure to recover from any prior surgery, or any major surgery within 4 weeks of
study entry

- Pregnant or lactating women

- History of allergy to eggs

- Other investigational drugs within 14 days of study entry

- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

- Concomitant steroids or hormones for the treatment of neoplasms