Acacia Pharma announced the initiation of a Phase IIa study of its product APD209 to treat cachexia in cancer patients. APD209 has been designed to target specific problems experienced by cachectic patients, in particular, inadequate nutrition and active muscle breakdown.
Cancer-related cachexia is a serious condition, involving wasting of muscle and fat, seen in at least half of all advanced cancer patients and is responsible for high levels of morbidity and mortality. Cachexia is thought to be the direct cause of death in around 20% of advanced cancer patients. However, there is no generally approved or accepted therapy and consequently the unmet medical need is very high.
Professor Kenneth Fearon, the Professor of Surgical Oncology and a world authority on cachexia, will conduct the study at the Royal Infirmary, Edinburgh, UK. It is planned to treat up to 16 patients for 8 weeks with APD209 and take detailed measurements of muscle size, muscle function, overall activity, quality of life and other parameters to assess the efficacy of the product. Safety and pharmacokinetics will also be evaluated. The trial is expected to last for 9 months and initial read-out is anticipated in fourth quarter 2009.