|Exclusion Criteria:||1) Pregnant or lactating women; men and women of reproductive potential who are not using effective contraception methods throughout the treatment period and for six weeks after discontinuation of treatment. Acceptable methods of contraceptive include complete abstinence, intrauterine contraceptive device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contaceptive suppository).|
2) Uncontrolled disseminated intravascular coagulation (DIC).
3) Patients who plan to undergo allogeneic BM transplantation within four weeks.
4) Other relevant diseases or adverse clinical conditions: -History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. -Symptomatic or unstable cardiac arrhythmias, and/or prolonged QT-QTc grade greater or equal to 2. -History of significant neurological or psychiatric disorders that may affect the patients compliance with the protocol assessments. -Active uncontrolled infection. -Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 x ULN in two different determinations performed one week apart). -Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis). -Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in the study.
5) Hematopoietic allogeneic stem cell transplantation within the last four months and/or active graft versus host disease, or prior autologous transplantation within the last four weeks.
6) Patients known to be human immunodeficiency virus (HIV) positive.
7) Cytotoxic chemotherapy within the last two weeks; radiation therapy within the last two weeks; biologic agents, including hematopoietic growth factors, within the last week; biologic agents, including hematopoietic growth factors, within the last week; hydroxurea, imatinib, corticosteroids and arsenic trioxide should be discontinued at least 24 hours prior to first study drug administration.
8) Treatment with any investigational product in the less than or equal to 5 half-lives period prior to inclusion in the study, or 30 days after therapy (in case of unknown half-life), unless evidence of rapid proliferating disease and upon discussion with the Sponsor.
9) Known central nervous system (CNS) disease.
10) Known hypersensitivity to any of the components of the drug product (DP).