Vical's Allovectin-7(R) Phase 3 Trial Receives Positive Review From Safety Monitoring Board


SAN DIEGO, Dec. 28, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 AIMM trial of Allovectin-7(R) in patients with metastatic melanoma has completed the trial's third scheduled safety analysis and recommended that the trial continue per the protocol. The trial is expected to complete enrollment of the planned 375 subjects in the next few weeks.

About the AIMM Trial

Vical is conducting the AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) trial, a Phase 3 pivotal trial of the company's Allovectin-7(R) cancer immunotherapeutic as first-line therapy in approximately 375 chemotherapy-naive patients with Stage III or IV metastatic melanoma in accordance with a Special Protocol Assessment (SPA) agreement completed with the U.S. Food and Drug Administration (FDA). The SPA specifies the trial objectives and design, clinical endpoints, and planned analyses expected to be needed for product approval. The AIMM trial is currently enrolling patients at clinical sites in key centers worldwide.

Under a previously announced collaborative agreement, AnGes MG, Inc., is funding the AIMM trial through a series of cash payments and equity investments. Vical has received the full $22.6 million committed by AnGes. In exchange for funding the trial, AnGes received exclusive marketing rights in Japan and other key Asian countries, and Vical is obligated to pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales. AnGes is obligated to pay Vical royalties on product sales in the specified Asian countries, plus certain sales-based milestone payments if defined sales levels are achieved. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7(R).

About Allovectin-7(R)

Allovectin-7(R) is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a Class I Major Histocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7(R) directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors. Vical conducted a large Phase 2 trial evaluating 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 FDA in an End-of-Phase 2 meeting, Vical designed the Phase 3 AIMM trial.

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.

2009年12月28日、Vical社は、Allovectin-7の転移性黒色腫（メラノーマ）第3相試験のプロトコール通りの続行が安全性モニタリング委員会に推奨されたと発表しました。