An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage

Inclusion Criteria:

- Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting:
refractory to two prior courses of therapy or primary refractory without response to
two previous courses of leukemia therapy.

- Patients must have received at least two previous courses of induction chemotherapy
to be considered in the second salvage setting.

- Patients who are in second relapse, must have had a duration of their second CR or
CRp of less than six months.

- Subjects must have adequate organ and immune function as indicated by the following
laboratory values:

- Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;

- Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);

- AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance
status of < 2, and an estimated life expectancy of at least eight weeks.

Exclusion Criteria:

- Clinical evidence of active central nervous system (CNS) leukemic involvement

- Active and uncontrolled infection

- Uncontrolled medical problems unrelated to the malignancy that impair patient ability
to give informed consent or unacceptably reduce the safety of the proposed treatment

- Neurologic or psychiatric disorders that would interfere with informed consent or
study follow-up

- Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related
compounds such as lamivudine or any of the stated ingredients

- A recent history of alcohol or other substance abuse

- Subjects who have used another investigational agent or participated in a clinical
trial within the last 14 days prior to enrolment

- Females with a positive pregnancy test at screening

- Subjects who have previously been enrolled into this study and subsequently withdrew