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Vical Presents Case Study on Successful Design of Allovectin® Phase 3 Melanoma Trial


01/30/2012


WASHINGTON, Jan. 30, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company will present a case study of its Allovectin® Phase 3 trial at the Phacilitate Cell & Gene Therapy Forum 2012 (Washington – January 30 - February 1). Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, is scheduled to present on Monday, January 30, at 2:30 p.m.

Dr. Rolland's presentation reviews the company's success in designing and conducting its ongoing multinational pivotal Phase 3 melanoma trial through the Special Protocol Assessment process with the U.S. Food and Drug Administration (FDA), and outlines manufacturing and commercialization considerations in support of the possible licensure of Allovectin®.

The Phase 3 trial, initiated in January 2007, is evaluating Allovectin® as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis: 260 for treatment with Allovectin® and 130 for treatment with physician's choice of either dacarbazine or temozolomide. The company is projecting completion of the Phase 3 trial and release of top-line data in mid-2012.

Allovectin® is a novel gene-based immunotherapeutic with unique mechanisms of action fundamentally different from currently approved treatments. Vical estimates that the worldwide market for Allovectin® as a treatment for metastatic melanoma is between $500 million and $1 billion annually, and potential applications for other types of cancer could further expand its total use.

Because the mechanisms of action for Allovectin® are not melanoma-specific, it has the potential to be used in other types of solid tumors. AnGes MG, Inc., has licensed rights to commercialize Allovectin® in specified Asian countries, and is primarily interested in developing Allovectin® as a treatment for head and neck cancer, which presents a significant unmet medical need in Asia. Vical has retained rights to commercialize Allovectin® in North America, Europe and other regions.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Risks and uncertainties include whether Vical or others will continue developing Allovectin®; whether top-line data from the Allovectin® Phase 3 trial will be released in mid-2012, if at all; whether Allovectin® will be approved as primary treatment for metastatic melanoma in the United States or any other countries; whether Allovectin® will generate revenues between $500 million and $1 billion annually, if any, for metastatic melanoma; whether Allovectin® will be successfully developed and commercialized for other solid tumor indications; whether AnGes will develop or commercialize Allovectin® in Asia for head and neck cancer or any other indication; whether Vical will commercialize Allovectin® in North America, Europe or any other regions; whether any product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACT: Alan R. Engbring
[phone]
Website: www.vical.com