A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

Study design: Phase I/II study The Phase I study is open-label with four increasing dose
levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each
cycle.

The Phase II study is open label with administration of the recommended phase dose of PTX-200
for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the
Phase I and Phase II parts of the study.

Inclusion Criteria:

- Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia),
or blast-phase CML (chronic myelogenous leukemia)

- Age ≥ 18 years

- ECOG Performance Status 0-2

- Patients must be able to give adequate informed consent

Exclusion Criteria:

- Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to
24 hours prior to beginning study drugs)

- Uncontrolled Disseminated Intravascular Coagulation (DIC)

- Uncontrolled diabetes mellitus

- Active, uncontrolled infection