06 December 2011
Lan Chem Laboratories Announces Positive Results From Phase IIa Cancer Cachexia Study
Armagh, UK – 6th December 2011: Lan Chem Laboratories, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces positive results from its Phase IIa study of APD209 in cancer cachexia. 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.
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.
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.
Cachexia occurs in up to 80% of patients with advanced cancer and is one of the most debilitating and distressing aspects of the disease. It is associated with reduced physical function, reduced tolerance of anticancer therapy and reduced survival. It has been defined as “a multifactorial syndrome, characterised by an ongoing loss of skeletal muscle mass (with or without loss of fat) that cannot be fully reversed by conventional nutritional support, which leads to progressive functional impairment”. There is no generally approved or accepted drug therapy and consequently the unmet medical need is extremely high.
Dr Gabriel Fox, Chief Medical Officer of Lan Chem Laboratories, said: “These data are very promising and exciting, given the difficulty of managing this condition and the absence of any approved therapy in most countries. The improvement in some of the patients after their course of APD209 has been truly extraordinary and the benefits to them and to their carers have been clear. We are now enthusiastic to move forward with our APD209 programme in larger, randomised trials.”