Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

Inclusion Criteria:

- male or female greater than or equal to 18 years of age

- have one of the following disease states: Acute Myeloid Leukemia (AML) (age <60
years) with relapsed/refractory disease; •Chronic Lymphocytic Leukemia (CLL) with
relapsed disease following a fludarabine-based regimen or relapsed disease following
an alkylator-based regimen

- are recovered from the acute adverse effects of prior therapies (excluding alopecia
and Grade ≤2 neuropathy).

- have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000
mg daily).

- have adequate hepatic function and renal function

- have an estimated life expectancy of >3 months

- female subject must have a negative serum pregnancy result within 7 days before the
start of the study; Both men and women must agree to use a medically acceptable form
of contraception throughout the treatment period and for 3 months after
discontinuation of treatment

Exclusion Criteria:

- are eligible for any standard therapy known to be life prolonging or life saving

- have diagnosis of AML French-American-British (FAB) classification (FAB) M3 (acute
promyelocytic leukemia (APL))

- are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or
hormonal treatment for cancer.

- have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide
at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of
other investigational agents within 4 weeks before study entry.

- prior radiation therapy with volume of bone marrow treated over 25%.

- use of immunosuppressive therapy, including systemic steroids within 7 days before
the first dose of SG2000.

- hyperleukocytosis (blast counts >30 000/mm3).

- history of allogeneic stem cell or solid organ transplantation.

- positive serology for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
or have HIV-AIDS, or active hepatitis B or C.

- history of other invasive malignancy within 3 years except for cervical carcinoma in
situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast
that has been surgically cured.

- have any coexisting medical condition that will substantially increase the risk
associated with the subject's participation in the study.

- have psychiatric disorders or altered mental status precluding understanding of the
informed consent process and/or completion of necessary studies.

- have persistent Grade 2 or greater toxicities from any cause (except alopecia or
peripheral neuropathy).

- are pregnant or breast-feeding.