SAN DIEGO, Oct. 8, 2014 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the issuance of six U.S. patents that provide broad coverage of DNA vaccines for herpes simplex virus type 2 (HSV-2), containing specific gene sequences and formulated with Vical's Vaxfectin® adjuvant. These patents resulted from collaboration with the laboratories of leading HSV experts Drs. David Koelle and Lawrence Corey at the University of Washington under a multi-year NIH grant. The intellectual property is jointly owned by the University of Washington and Vical.
The new patents cover composition of matter of plasmid DNA vaccines encoding several HSV-2 antigens, including envelope and tegument viral proteins, separately or in combination, and formulated with Vical's Vaxfectin® adjuvant. These new patents add to Vical's family of intellectual property that is 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, will result in expression of the proteins encoded by the genetic sequences. Vical has additional issued patents covering the composition and use of its Vaxfectin® adjuvant. The six recently issued HSV-2 U.S. patents are 8,828,408; 8,834,894; 8,840,903; 8,840,904; 8,852,610; and 8,852,611. Vical's five previously issued HSV-2 U.S. patents include 7,628,993; 7,879,339; 7,935,352; 8,263,087; and 8,293,248.
HSV-2 is a sexually transmitted virus that is the main cause of recurrent genital herpes, accounting for the majority of genital ulcerative lesions worldwide. Genital herpes is not only physically taxing (pain, itching and other morbidities), but also psychologically debilitating, especially given the fear of transmission. The CDC estimated the U.S. prevalence of HSV-2 to be 16% of 14- to 49-year-olds and the WHO estimated the global prevalence to be roughly 16% of people aged 15 to 49 years, or over 500 million. Only 10% to 25% of HSV-2-seropositive individuals are symptomatic and recognize their genital herpes infection.High unmet medical needs exist for new treatments because existing treatments of acyclovir-based antivirals can temporarily reduce but not eliminate genital herpes, viral shedding, and transmission; these drugs have not appreciably impacted HSV-2 seroprevalence rates despite over 30 years of usage. A therapeutic vaccine is a novel approach for treating genital herpes. Vical is currently testing its therapeutic HSV-2 DNA vaccine in a Phase 1/2 trial designed to reduce the frequency and magnitude of viral shedding and reduce genital lesion recurrences in HSV-2 positive subjects aged 18 to 50 years at seven U.S. clinical sites. This trial is proceeding according to plan, with ongoing enrollment and dosing of subjects in the efficacy cohort. Vical expects the trial to be fully enrolled in the fourth quarter of 2014, with topline data projected to be available in mid-2015. Further details about this trial can be found at ClinicalTrials.gov, NCT02030301.
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, in which the expressed protein is an immunogen; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines 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.
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 technologies and their potential application in vaccines against HSV-2 and whether the HSV-2 clinical trial will fully enroll. Risks and uncertainties include 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 the clinical 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 continue development of HSV-2 product candidates; whether Vical will seek or gain approval to market its HSV-2 vaccine; whether Vical will fully enroll the Phase 1/2 trial by the fourth quarter of 2014, if at all; and whether topline data will be available by mid-2015; 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.