Acacia Pharma initiates Phase IIa study with APD209 in cancer cachexia patients

Cambridge, UK – Acacia Pharma, a pharmaceutical company specialising in the development of supportive care drugs, 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.

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.”

Contacts

Acacia Pharma
Telephone: +44 (0)1223 875132
Dr Julian Gilbert

Citigate Dewe Rogerson
Telephone: +44 (0) 20 7638 9571
David Dible
Dr Mark Swallow


About Acacia Pharma 

Acacia Pharma is a pharmaceutical company focused on supportive care, particularly cancer supportive care which is a rapidly developing commercial opportunity. The growth in the cancer supportive care market has been driven by the increasing incidence of cancer, the expansion of effective cancer therapies and the desire to improve both the effectiveness of treatment and the quality of life of cancer patients.  

Acacia Pharma has generated a pipeline of product opportunities addressing a number of supportive care indications using a commercially driven approach to product discovery, based on known drugs. This strategy leads to product opportunities with a higher probability of success and enables rapid clinical proof-of concept. The Company’s lead product opportunity APD405 for the prophylaxis and treatment of nausea & vomiting, has completed Phase I clinical development with Phase II planned for 2Q 2009. Acacia’s second development opportunity, APD209 for cancer cachexia, has completed preclinical evaluation and a Phase IIa study in cancer cachexia patients has been initiated. In addition, the Company is also working on products for additional supportive care indications such as xerostomia, cancer fatigue and skin toxicities associated with certain new anti-cancer agents. Acacia’s products are expected to reach the market quickly given that they are based on the novel use of well-characterised pharmaceuticals.  
Acacia Pharma is led by an experienced management team who have already successfully built and exited a number of life sciences companies. Management and Gilde Healthcare are the Company’s key shareholders. Acacia Pharma is based in Cambridge, UK.