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Trials & Filings

Acacia Begins CINV Study

Tests dopamine antagonist in chemotherapy setting

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Acacia Pharma has begun 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.

The study is taking place in around 25 centers in the UK, Denmark, Germany and the U.S., and aims to recruit 315 cancer patients receiving highly emetogenic chemotherapy (HEC). The trial compares three 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 five 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.

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.

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