30 October 2013
Phase 2 Study Initiated With APD403 In CINV
Cambridge, UK – 30th October 2013: Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, announces the initiation of a Phase II study of APD403 in the prevention of chemotherapy-induced nausea & vomiting (CINV). CINV remains a clinically significant problem in cancer patients receiving emetogenic chemotherapy despite the availability of a range of anti-emetic medications.
CINV occurs in approximately 70% of all cancer patients receiving chemotherapy and in 90% of those receiving highly emetogenic chemotherapy (HEC). It is one of the major side effects of cancer therapy and a considerable concern for patients. There are two major types of CINV, referred to as acute CINV which occurs on the day of treatment, and delayed CINV which occurs up to five days following chemotherapy. Despite the improvements in managing CINV there remains a clear unmet need to reduce the incidence of nausea, especially in delayed CINV, as standard regimens are relatively effective at stopping patients being sick (vomiting) but much less so at stopping them feeling sick (nausea), which is often the most distressing symptom.
The Phase II study is taking place in around 25 major centres in the UK, Denmark, Germany and the USA and aims to recruit 315 cancer patients receiving HEC. The trial compares 3 doses of APD403 against placebo in the delayed phase of CINV. The primary endpoint is no vomiting or retching and no requirement for anti-emetic rescue medication for 5 days after the start of chemotherapy administration. The incidence and severity of nausea is being studied as a secondary endpoint.
Acacia Pharma has previously generated positive Phase IIa clinical data when the drug was given prophylactically to cancer patients being treated with the HEC, cisplatin. These data showed APD403 has the potential to be an effective anti-emetic, particularly controlling nausea, the major unmet need.
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer commented: “We are delighted to be working with an outstanding international group of investigators, including some of the world’s leading authorities on CINV. Our clinical sites are highly enthusiastic about investigating this promising potential addition to the anti-emetic armamentarium.”
Acacia Pharma’s CEO, Dr Julian Gilbert, added: “CINV is an incredibly debilitating condition. Although significant advances have been made in the management of vomiting, nausea remains a major issue. We believe APD403 is a good anti-vomiting agent and an excellent anti-nauseant, thereby having the potential to make a significant contribution to cancer care.”
APD403 contains the currently marketed dopamine D2 /D3 antagonist amisulpride for the new, patent-protected, use of management of CINV. The active ingredient is also being developed as APD421 for the prevention of post-operative nausea & vomiting (PONV), with two pivotal Phase III clinical studies having been initiated recently.