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Allovectin (Velimogene Aliplasmid) Fails to Meet Efficacy Endpoints in Melanoma Trial

First-line drug does not improve response or overall survival versus chemotherapy (August 12)

Disappointing results have been reported from a phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma.

The 390-subject trial failed to demonstrate a statistically significant improvement versus first-line chemotherapy for either the primary endpoint of an objective response at 24 weeks or more after randomization or the secondary endpoint of overall survival.

Based on this outcome, the compound’s developer (Vical, Inc.) is terminating the Allovectin program.

Allovectin (velimogene aliplasmid) is an investigational DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. The drug expresses two genes (HLA-B7 and ß2 microglobulin) that together form major histocompatibility complex (MHC) class 1 molecules. Allovectin was being evaluated as first-line treatment for stage III and IV melanoma, where it was intended to provide advantages over current first-line chemotherapy.

Source: Vical, Inc.; August 12, 2013.

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