BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

Exclusion Criteria

• •Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing)
• •Plans for lung transplantation or lung reduction surgery within four months of enrollment
• •Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing
• •History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR \< 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc.
• •Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency
• •Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc.
• •Hemoglobin concentration below 11.0 g/dL at screening.
• •Liver disease or liver injury.
• •Use of other investigational drugs at the time of enrollment, or within 30 days and for any other limitation of participation in an investigational trial based on local regulations.
• •Women of child-bearing potential.