Vical Phase 3 Trial of Allovectin Fails to Meet Efficacy Endpoints

On August 12, 2013 Vical reported top-line results from a Phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma (Press release Vical, AUG 12, 2013, View Source [SID:1234501043]). The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

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"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."