APG101 in Myelodysplastic Syndrome

Inclusion Criteria: * Signed informed consent * Male and female patients with cytologically or histologically established diagnosis of de novo MDS according to the WHO-classification, either previously treated or untreated, presenting with low or intermediate risk features according to WHO prognostic status scale (WPSS) * Diagnosis of MDS with a medullary blast count of less than 5% has to be established or confirmed by bone marrow morphology * MDS with 5q deletion only if Lenalidomide is not a treatment option * Red blood cell transfusion dependency of at least 4 units of packed red blood cells (PRBC) during the last 8 weeks before inclusion. Only PRBC transfusions given for a Hb level ≤ 9g/dl or a haemoglobin level \> 9g/dl, if clinically indicated (e.g. coronary heart disease, long distance travel), will count. * Patients refractory to Erythropoietin-stimulating agents (ESA) (as assessed after at least 8 weeks of treatment) or with a low possibility to respond to ESA treatment * at least 18 years old, smoking or non-smoking, of any ethnic origin * ECOG performance status ≤ 2 * Suitable veins or existing port system for intra-venous infusion * Adequate contraception Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * MDS with medullary blast count ≥ 5% * Chronic monomyeloic leucemia (CMML) * Therapy-related / secondary MDS * High-risk karyotype according to WPSS * Patients scheduled for bone marrow or stem cell transplant within the next 6 months * Parallel treatment with ESA or with other experimental therapy * Prior chemotherapy (including Vidaza) * Treatment within the last 6 weeks with histone deacetylase (HDAC) inhibitors or ESAs * Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion * Active uncontrolled infection * HIV, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection * Any other condition / treatment or past medical history of diseases with poor prognosis that, in the opinion of the investigator, might interfere with the study * History of or current drug or substance abuse * History of other (haemato-) oncological disease (except for non-melanoma skin cancer and adequately treated in situ carcinoma of the cervix) * Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study * Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study * Subject is the investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. * Hypersensitivity to recombinant proteins or excipients in the investigational drug * Pregnancy or breast feeding * Vulnerable patients (e.g., minors or persons kept in detention)