Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

This randomized open-label study is designed to evaluate whether the addition of either or
both different dose levels of CX-01 to standard induction therapy and consolidation therapy
has a beneficial effect in newly diagnosed AML patients (60 years of age or older) when
compared to patients receiving standard induction and consolidation chemotherapy alone. 75
patients will be randomized to one of 3 treatment groups to receive standard
induction/consolidation therapy alone or standard induction/consolidation therapy with CX-01
at one of 2 different dose levels (lower and higher). Patients will receive up to 2 induction
cycles and up to 2 consolidation cycles and will participate in the study for up to 18
months. Clinical laboratory tests will be conducted routinely, and bone marrow aspirates and
biopsies will be performed during the induction cycles. Safety will be monitored through
adverse events and clinical laboratory results.

Inclusion Criteria:

- Newly diagnosed, de novo or secondary, previously untreated AML

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

- Acute promyelocytic leukemia

- Prior chemotherapy for AML

- Prior intensive chemotherapy or stem cell transplantation for the treatment of
myelodysplastic syndrome

- CNS leukemia