16 February 2011
Phase 2a Clinical Trial Initiated With APD421 For Nausea & Vomiting
Cambridge, UK – 16th February 2011: Acacia Pharma, a pharmaceutical company specialising in the development of drugs for cancer supportive care, announces it has initiated a dose-escalating, Phase 2a proof-of-concept study of its product candidate APD421.
APD421 is an intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting. Acacia Pharma has shown APD421 to be highly effective in preclinical models of both chemotherapy-induced nausea & vomiting (CINV) and post-operative nausea and vomiting (PONV). APD421 could offer advantages over existing D2 antagonists used as anti-emetics, given its superior therapeutic window.
The single ascending dose study is taking place in four hospitals in Denmark and the UK, and will enrol up to 54 cancer patients receiving the highly emetogenic chemotherapy drug cisplatin. The primary endpoint will be protection from vomiting and no requirement for anti-emetic rescue medication during the first 24 hours after dosing with cisplatin.
Upon successful completion of this proof-of-concept study, Acacia Pharma will proceed to a dose-ranging study of APD421 in adult surgical patients. PONV offers the most rapid development opportunity for APD421, owing to the acute nature of the condition and the large number of surgical procedures performed. Despite a number of anti-emetics in common use, many patients still suffer post-operatively with vomiting and especially nausea. About a third of those given prophylaxis for PONV require rescue therapy in the first six hours after surgery, representing a substantial commercial opportunity. More than 130 million surgical procedures are performed worldwide each year, PONV occurring in approximately 35% of cases and in 70% of those classed as high risk.
Dr Julian Gilbert, Acacia Pharma’s CEO said, “Acacia Pharma has generated excellent preclinical data on APD421. This innovative proof-of-concept study is designed to confirm that the anti-emetic effects previously seen by Acacia Pharma translate to man, before we embark upon Phase II dose ranging.”