SAN DIEGO, May 4, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the issuance of U.S. Patent No. 7,935,352, assigned to Vical and the University of Washington, covering DNA vaccines for herpes simplex virus type 2 (HSV-2). Prior patents from this collaboration are U.S. Patent Nos. 7,628,993 and 7,879,339. Vical is collaborating with the University of Washington School of Medicine and the Sealy Center for Vaccine Development, both centers of excellence in herpes virus research, under a previously disclosed grant on the preclinical development of an HSV-2 vaccine. The initial focus will be for people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups and the associated viral shedding and transmission. The vaccine will be evaluated with Vical's Vaxfectin® adjuvant.
HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes. Approximately one out of every six individuals in the United States and an estimated one out of every four worldwide is infected by HSV-2 before age 50. HSV-2 infections are persistent and result in periodic virus shedding. HSV-2 infection also significantly increases the risk of acquiring HIV-1. In the United States, at least 40 million people are infected with HSV-2, and approximately 1.6 million people are newly infected each year, with approximately 500,000 of those suffering from disease symptoms. Even higher infection rates are evident in developing countries, with further complications in people also infected with HIV. HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes.
There is currently no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost over the years and potential for drug resistance highlight the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission. Estimated direct costs of treating HSV-2 in the United States alone are close to $1 billion annually, primarily for drugs and outpatient medical care, plus additional indirect costs of more than $200 million.
The new '352 patent covers DNA vaccines containing the HSV-2 UL47 gene, which encodes the VP13/14 tegument protein, formulated with or without Vical's Vaxfectin® adjuvant. It adds to Vical's family of patents in the United States and other key regions based on the company's discovery that administering genetic sequences such as DNA or RNA into the body, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the genetic sequences. Vical has additional issued patents covering the composition and use of the Vaxfectin® adjuvant.
The preclinical development is being funded under a two-year, $2.0 million Phase II Small Business Technology Transfer (STTR) grant awarded in 2008 by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The grant period was extended to allow preclinical development to continue for a third year. The $2.0 million Phase II STTR grant supplements the $0.3 million awarded to Vical in 2005 for the HSV-2 vaccine program under a Phase I STTR grant from the NIAID, which partially funded Vical's initial development of the HSV-2 vaccine.
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 .
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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 the scope of coverage of and potential applications for Vical's patents, the potential uses and benefits of Vical's vaccine technologies and their potential application in vaccines against HSV-2, as well as Vical's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Vical's technology will be successfully applied; whether all funding under the grant will be received by the company; whether the preclinical development efforts will result in a vaccine candidate that can generate immune responses sufficient to reduce or eliminate periodic viral flare-ups and the associated viral shedding and transmission; whether the Vaxfectin® adjuvant will effectively enhance the performance of the HSV-2 vaccine; whether Vical or others will advance the HSV-2 vaccine candidate into human clinical testing; whether Vical's issued patents will be challenged and whether such challenges will have an adverse effect on the scope or validity of the patents; whether Vical will pursue enforcement of its issued patents or be successful in any such enforcement efforts; whether Vical will successfully prosecute additional patent applications and if so, whether such applications will lead to the issuance of additional patents; 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 (858) 646-1127 Website: www.vical.com