Vical Incorporated announced that its Vaxfectin(R)-formulated plasmid DNA (pDNA) vaccines against herpes simplex virus type 2 (HSV-2) provided complete protection in guinea pigs against both primary and recurrent HSV-2 disease
SEATTLE, WA, USA | OCTOBER 3, 2011 | Vical Incorporated (Nasdaq:VICL - News) today announced that its Vaxfectin(R)-formulated plasmid DNA (pDNA) vaccines against herpes simplex virus type 2 (HSV-2) provided complete protection in guinea pigs against both primary and recurrent HSV-2 disease. The vaccines also significantly reduced genital lesion recurrence and viral shedding as well as latent infection in the central nervous system.
Data from multiple prophylactic and therapeutic animal studies demonstrated:
Prophylactic pDNA vaccines encoding HSV-2 glycoprotein D (gD) alone or encoding gD plus the HSV-2 tegument proteins UL46 and UL47 provided complete protection from both primary and recurrent disease (p<0.001). Both prophylactic vaccines significantly reduced viral replication at the primary infection site (p<0.001). Both prophylactic vaccines significantly reduced detectable HSV-2 infection at the latent site (p<0.001 for gD alone and p<0.0001 for gD/UL46/UL47). The therapeutic pDNA vaccine encoding gD plus UL46 and UL47 significantly reduced the frequency of genital lesion outbreaks in animals with pre-established HSV-2 infections (p<0.05). The therapeutic vaccine significantly reduced the frequency of genital viral shedding (p<0.05).
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"The ability of these Vaxfectin(R)-formulated DNA vaccines to provide complete protection against both primary and recurrent HSV-2 disease in this well-established guinea pig model is an excellent confirmation of our earlier studies in mice," said Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development. "The concurrent reductions of viral shedding and latent infection demonstrate the potential for meaningful benefit in both prophylactic and therapeutic settings. We are eager to complete our grant-funded preclinical development in this exciting program and evaluate the best path forward into human clinical testing."
Vical is collaborating with the University of Washington School of Medicine and the Sealy Center for Vaccine Development at the University of Texas Medical Branch under a previously disclosed grant on the preclinical development of a HSV-2 vaccine formulated with Vical's Vaxfectin(R) adjuvant. The initial clinical focus will be for people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups as well as viral shedding and transmission. The guinea pig studies were directed by Nigel Bourne, Ph.D., Professor of Pediatrics, Microbiology and Immunology, and Senior Scientist in the Sealy Center for Vaccine Development at the University of Texas Medical Branch in Galveston, Texas.
The results are being presented today in a poster, "An Adjuvanted HSV-2 Plasmid DNA Vaccine is Effective for Prophylactic and Therapeutic Use in the Guinea Pig Model of Genital Herpes," at the 5th Vaccine and International Society for Vaccines Annual Global Congress (Seattle, WA -- October 2-4).
About HSV-2
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.
There is no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, lack of patient compliance, cumulative cost and potential for drug resistance further underscore the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission. Estimated costs of treating HSV-2 in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care. Additional indirect costs from HSV-2 infection, such as lost work hours, are more than $200 million annually in the United States.
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 vical.com.
SOURCE: Vical Incorporated
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