12 December 2018
Positive Clinical Results for APD403 in CINV Published in Supportive Care in Cancer
Cambridge, UK and Indianapolis, US – 12 December 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that data and analyses from its positive Phase 2 clinical trial of APD403 (intravenous and oral amisulpride) in chemotherapy induced nausea and vomiting (CINV) have been published (Herrtedt et al1) in the online edition of the leading peer-reviewed journal Supportive Care in Cancer, the official publication of the Multinational Association of Supportive Care in Cancer (MASCC). Positive headline results were first announced by the Company in May 2015.
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, commented: “Nausea and vomiting remain important issues for patients receiving cytotoxic chemotherapy for cancer, despite the use of multi-drug prophylaxis. These data suggest that amisulpride, a dopamine-antagonist antiemetic, may have potential utility as prophylaxis against CINV associated with the most emetogenic chemotherapy regimens. This paves the way for testing in larger, Phase 3 trials, through which we aim to assess the efficacy and safety of amisulpride when added to the current standard of care.”
Herrstedt, J. et al. Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial Supportive Care in Cancer 2018, doi:10.1007/s00520-018-4564-8 [epub ahead of print]
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
Chemotherapy-induced nausea & vomiting (CINV) is common side effect of cancer chemotherapy. The incidence of CINV varies with the type of chemotherapy, dose, the route of administration and patient-specific factors. The incidence of CINV in patients receiving highly emetogenic chemotherapy (HEC) is over 90% while in those receiving moderately emetogenic chemotherapy (MEC) it is between 30 and 90%. Nausea and vomiting can occur on the day of chemotherapy administration (acute CINV) and can persist for two to five days after the administration of chemotherapy (delayed CINV). CINV has a significant effect on quality of life and can compromise patient health. Severe CINV may necessitate a delay or reduction in chemotherapy and can ultimately lead to treatment withdrawal. The goal of CINV management is the prevention, rather than treatment, of symptoms.
The worldwide therapeutic guidelines for the management of CINV, recommend the use of “triple therapy” comprising a 5HT3 antagonist (e.g. ondansetron), a corticosteroid (e.g. dexamethasone) and an NK-1 antagonist (e.g. aprepitant) in patients receiving HEC. The guidelines recommend the use of a 5HT3 antagonist and a corticosteroid in combination for patients receiving MEC (Roila et al 2010). The use of triple therapy prophylaxis can produce a complete response rate (no vomiting and no rescue medication) in acute CINV of up to 85% of patients receiving HEC. However, this complete response rate reduces down to as low as 50% in the delayed CINV (Warr et al 2005), with failures being driven primarily by nausea. The management of nausea in the delayed phase of CINV is considered to be the major unmet medical need.
APD403 comprises the dopamine antagonist amisulpride, which Acacia Pharma has repurposed for the completely new, patent-protected use of management of CINV. Amisulpride is not currently available in the US. A New Drug Application (NDA) for BARHEMSYS™ (intravenous amisulpride) is under review by the US Food and Drug Administration (FDA).
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Group's lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. www.acaciapharma.com
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