Accelovance, a global contract research organization (CRO) has announced the completion of enrollment and delivery of the final locked database to Heron Therapeutics, Inc. for the Phase 3 trial of its 5-HT3 receptor antagonist product candidate SUSTOL® (granisetron injection, extended release) as part of a three-drug regimen with the IV NK1 receptor antagonist fosaprepitant and IV corticosteroid dexamethasone for the prevention of delayed chemotherapy induced-nausea and vomiting (CINV) associated with highly emetogenic chemotherapy (HEC), in 14 months from opening the trial.
The Phase 3 trial, known as the MAGIC trial, randomized over 900 patients undergoing HEC treatment for various tumor types and is the only Phase 3 clinical trial CINV in a HEC population performed to date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist (in this case ondansetron), fosaprepitant, and dexamethasone. The trial's primary endpoint of Complete Response, defined as no emesis and no rescue medications during the delayed phase of CINV, (24-120 hours) following administration of HEC agents, was statistically significant in favor of the SUSTOL group (64.7% vs. 56.5%, p=0.014).
"We would like to commend the team at Accelovance for rapidly providing to Heron a cleaned and locked database following treatment of the last patient in the MAGIC trial. The contribution of Accelovance has helped us with our goal of resubmitting our New Drug Application (NDA) for SUSTOL to the US Food and Drug Administration (FDA) by mid-2015," commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics.
Accelovance was selected by Heron to provide project management, clinical monitoring, data management, and medical monitoring CRO services for the MAGIC trial. Stephen J. Trevisan, Accelovance's President and CEO commented, "Our talented CRO team members have enjoyed supporting the Heron team and contributing to the advancement of SUSTOL for CINV. We're proud to have been a part of this trial and to know that, pending FDA review and approval, there may soon be a new option for patients suffering from chemotherapy-induced nausea and vomiting."