Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome

Inclusion Criteria:

- Primary or de Novo MDS

- Low or Intermediate-1 IPSS risk MDS

- Deletion of the 5q chromosome [del(5q) MDS]

- Refractory or resistant to lenalidomide (Revlimid)

- ECOG performance score of 0 or 1

- Documentation of significant anemia with or without additional cytopenia

- Adequate kidney and liver function

- Patients must have discontinued hematopoietic growth factors at least 3 weeks prior
to study entry

Exclusion Criteria:

- Prior allogenic bone marrow transplant for MDS

- Known sensitivity to ezatiostat (injection or oral tablets)

- Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)

- History of MDS IPSS risk score of greater than 1.0

- Pregnant or lactating women

- Any severe concurrent disease, infection or comorbidity that, in the judgement of the
investigator, would make the patient inappropriate for study entry

- Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other
conditions (such as new adrenal failure, asthma, arthritis) or brief steroid use
(such as tapered dosing for an acute non-MDS condition)

- History of hepatitis B or C, or HIV