Date: 2011-12-06
Type of information:
phase: 2a
Announcement: results
Company: Acacia Pharma (UK)
Product: APD209
Action mechanism: APD209 comprises a new and patent protected use for an oral combination of two currently marketed drugs and has been designed to increase appetite, muscle mass and muscle function.
Disease: cancer cachexia
Therapeutic area: Cancer Oncology
Country: UK
Trial
details: The Phase IIa study was led by Professor Kenneth Fearon, Professor of Surgical Oncology and a world authority on cachexia, at the Royal Infirmary, Edinburgh, UK. Thirteen cancer patients, with an average weight loss of 11.4% (range 5-25%) in the previous six months, were treated with APD209 for up to eight weeks and detailed measurements of muscle size, muscle function, physical activity and quality of life were taken to assess the efficacy of the product.
Latest
news: Acacia Pharma has announced positive results from its Phase IIa study of APD209 in cancer cachexia. Seven patients completed the eight week course of treatment, six achieving a major response, according to pre-defined criteria. These required an increase in quadriceps muscle size of at least 4% (measured by MRI) and/or an increase of at least 10% in quadriceps strength (measured with specialist strength and power equipment). Among the responders, the average increase in quadriceps volume was 6%, while quadriceps strength rose on average 16%. Hand grip strength increased on average 17%. Physical activity was markedly improved in three patients, the average daily step count more than doubling between the start and end of treatment in two of the patients. Although the population was frail and elderly, side effects considered to be related to APD209 were few and generally mild. The results from this trial have been selected for an oral presentation at the 6th Cachexia Conference in Milan on 9th December. Acacia Pharma intends now to move forward with the APD209 programme in larger, randomised trials.
