NIH Supports Phase 1 Clinical Trial Of Vical’s DNA-Based Anthrax Vaccine

SAN DIEGO, June 1 /PRNewswire-FirstCall/ -- Vical Incorporated announced today that National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH) has advised the company that it will support a Phase 1 clinical trial of the company’s investigational plasmid DNA-based anthrax vaccine at two NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). Clinical trial materials are ready for shipment, and the trial is expected to begin within the next few weeks.

“This partnership with NIAID provides funding and advances our anthrax vaccine into human clinical testing,” said David C. Kaslow, M.D., Vical’s Chief Scientific Officer. “Our bivalent vaccine has the potential to provide broader protection against anthrax than the currently licensed vaccine and potentially superior stability for stockpiling. In addition, this trial provides an opportunity to confirm in humans the potent antibody responses that our vaccine elicited in animal studies.”

The VTEUs, established in 1962, are a nationwide network of university-affiliated research hospitals that conduct Phase 1 and Phase 2 clinical trials for NIAID. Through these centers, candidate vaccines of potential public health significance are tested and evaluated for safety and efficacy. The VTEUs have conducted clinical trials of vaccines for numerous infectious diseases, including those that might be introduced through acts of bioterrorism.

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 has retained all rights to its internally developed product candidates. 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 serve significant unmet medical needs. Additional information on Vical is available at http://www.vical.com/.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about a commitment to funding by the NIAID, the scheduled commencement of clinical trials for the company’s anthrax vaccine, the use of Vical’s DNA delivery technology in the development of vaccines for anthrax and other infectious diseases, and the potential for Vical’s DNA vaccine technology to be applied to anthrax and other infectious diseases, as well as the company’s focus, collaborative partners, product candidates, and developmental status. Risks and uncertainties include whether human trials of the company’s anthrax vaccine will confirm the antibody responses observed in animal studies, whether vaccines for anthrax or other infectious diseases will be developed and approved, whether use of Vical’s technology in such vaccines will provide protective immune responses to such diseases and will result in products that are better than competing products, whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether use of the company’s technology will extend to new product opportunities for humans and animals, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, the dependence of the company on its collaborative partners, 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.

Contacts: Investors: Media: Alan R. Engbring Susan Neath Vical Incorporated Atkins + Associates (858) 646-1127 (858) 527-3486 Website: http://www.vical.com/

Vical Incorporated

CONTACT: Investors - Alan R. Engbring of Vical Incorporated,+1-858-646-1127; or Media - Susan Neath of Atkins + Associates,+1-858-527-3486, for Vical Incorporated

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