Acacia Initiates Phase IIA Study with APD209 in Cancer Cachexia Patients
News Mar 31, 2009
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.
Dr Julian Gilbert, CEO of Acacia Pharma, said: “We are excited to be initiating our first Phase IIa study so early in our company’s development and especially pleased to be investigating a product with real promise in an area of such high unmet medical need. APD209 fits our corporate strategy of developing therapies in supportive care which can make a major difference to patients while at the same time representing an exciting commercial opportunity.”
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, commented: “Cancer cachexia is strongly associated with poor patient survival and poor quality of life. Acacia’s market research indicates that oncologists and palliative care specialists consider it a major problem and seek a product to improve muscle mass and function, and to stimulate appetite. APD209 was therefore designed to meet this profile. We are delighted to be working with Professor Fearon and his team, and look forward to determining the product’s efficacy in this debilitating condition.”