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Vical Promotes Melanoma Awareness Month With Allovectin-7(R) Video Report
Date:4/23/2008

uating Allovectin-7(R) immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma. Based on advice from clinical experts and detailed guidance received from the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting, Vical successfully completed a Special Protocol Assessment (SPA) with the FDA for a Phase 3 trial (the Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma, or AIMM trial) for certain patients with Stage III or Stage IV melanoma. The SPA agreement specifies that the trial design and planned analyses address the study's objectives and the resulting study data could provide the primary basis to support a product license application.

Allovectin-7(R) has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA's Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.

Patients featured in the video report were selected from complete responders in earlier trials, and do not represent the majority. In the Phase 2 study, the overall response rate was 11.8%, including 11 partial responders and 4 complete responders from the 127 patients treated. The drug-related side effects in the Phase 2 study were predominantly mild and temporary, including pain and inflammation at the injection site and flu-like symptoms such as fatigue, fever, muscle and joint pain, and headache.

About the AIMM Trial

In early 2007, Vical initiated a Phase 3 pivotal trial of the company's Allovectin-7(R) cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with Stage III or IV metastatic melanoma. The AIMM trial is being conducted in accordance with the SPA agreement at more than 60 clinical sites, and is currently enrolling patients in the United States, Canada and Europe. AnGes M
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SOURCE Vical Incorporated
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