Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Inclusion Criteria: * Male or female patients with low or intermediate (INT-1) risk MDS, determined via IPSS criteria, with transfusional iron overload. NOTE: Bone marrow morphology and cytogenetic studies completed within 3 months prior to screening can be used if the patient has been hematologically stable. Every attempt to obtain cytogenetics studies should be made; however, if there is culture failure, repeat marrow aspiration will not be mandated. In this case, RAEB with less than 11% marrow blasts will be accepted. * Patients on chelation therapy at the time of screening required a 1-day wash out prior to the first dose of study drug. * Age: greater than or equal to 18 years * Serum ferritin: * For entry into the screening period: serum ferritin greater than or equal to 1000 µg/mL on at least two occasions, at least two weeks apart, during the prior year. Samples must be obtained in the absence of concomitant infection; * For enrollment into the study: serum ferritin greater than or equal to 1000 µg/mL at screening (via the central lab) obtained in the absence of concomitant infection * A lifetime minimum of 20 previous packed red cell transfusions * Life expectancy greater than or equal to 6 months * Women must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined by amenorrhea for at least 12 months). * Able to provide written informed consent Exclusion Criteria: * Serum creatinine greater than 2 × upper limit of normal (ULN) * ALT or AST greater than 5 × ULN. * Clinical or laboratory evidence of active hepatitis B or hepatitis C (HBsAg in the absence of HBsAb -OR- HCV Ab positive with HCV RNA positive and ALT above the normal range) * Significant proteinuria as indicated by a urinary protein/creatinine ratio greater than 0.5 mg/mg in a non-first void urine sample during screening (or alternatively in two of three samples obtained for screening) * History of HIV positive test result (ELISA or Western blot) * ECOG performance status greater than 2 * Uncontrolled systemic hypertension * Unstable cardiac disease not controlled by standard medical therapy * Third degree atrioventricular (AV) block or QT interval prolongation above the normal range * History of clinically relevant ocular toxicity related to iron chelation * Pregnancy or breast feeding * Treatment with a systemic investigational drug within the past 4 weeks or a topical investigational drug within the past 7 days. * Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following: * inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding; * major gastrointestinal tract surgery, such as gastrectomy, gastroenterostomy, or bowel resection; * pancreatic injury or pancreatitis or indications of impaired pancreatic function/injury, as indicated by abnormal lipase or amylase; * urinary obstruction or difficulty in voiding. * History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative