SAN DIEGO, May 25, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company is collaborating with leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University (VCU) under a five-year, approximately $4.0 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The grant will support development and animal testing of novel vaccine approaches designed to protect women of child-bearing potential from infection with cytomegalovirus (CMV). Vical will produce the DNA vaccines and Vaxfectin^® adjuvant, and will conduct the animal studies funded by the grant.

"The most promising CMV vaccine candidates have provided encouraging immune responses and partial protection," said Dr. Adler. "The growing body of knowledge about the biology of CMV infection has illuminated new pathways that may offer even broader protection. Our collaboration with Vical, with the support of the NIAID grant funding, will allow us to evaluate comprehensive CMV vaccine strategies through proof-of-concept studies in animal models. We hope that the results of these efforts will lead to a successful prophylactic vaccine solution to avert the serious consequences of congenital CMV infection."

Past development of protein-based prophylactic CMV vaccines has focused on antibody-mediated immune responses against the CMV glycoprotein B (gB) antigen, which has achieved up to 50% protective efficacy. The gB vaccines have proven most effective at preventing CMV infection of human fibroblast cells, which form the connective tissues that provide the body's structure. Recent studies at VCU have identified additional CMV antigens that may prevent CMV infection of human epithelial cells, which form the surface linings of the body's structures and cavities. Evaluating vaccine strategies targeting the new antigens and combining them with gB-based vaccines that neutralize CMV against fibroblast entry are the primary goals of the new grant.

About CMV

CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two different vaccine approaches for these distinct market segments.

Vical's Prophylactic CMV Vaccine Franchise

Mothers who are infected with CMV during pregnancy, especially during the first trimester, can transmit the virus to the fetus, where it affects the development of the central nervous system. Congenital CMV is the leading infectious disease cause of birth defects in the United States, similar to rubella in the '40s and '50s before an effective vaccine was available. CMV-infected infants can be affected by blindness, deafness and mental retardation and these consequences are frequently undiagnosed until the child reaches several years of age. Widespread vaccination of adolescent females has the potential to significantly reduce or even eliminate congenital CMV over time, and this market segment offers a significant commercial vaccine target. The successful launch of Merck's Gardasil^® vaccine for the prevention of human papillomavirus (HPV), a primary cause of cervical cancer, has demonstrated the size and receptivity of the adolescent female vaccine market.

To prevent infection in females of child-bearing potential, Vical is developing CyMVectin™, a prophylactic DNA vaccine encoding the CMV gB and potentially the phosphoprotein 65 (pp65) antigens. The CyMVectin™ vaccine is formulated with Vical's Vaxfectin^® adjuvant in order to enhance antibody and T-cell responses. The U.S. Food and Drug Administration (FDA) has allowed the company's Investigational New Drug (IND) application for a Phase 1 trial of the CyMVectin™ vaccine, and Vical is exploring collaborative opportunities for further development and commercialization.

Vical also holds an exclusive, worldwide license from The Wistar Institute to Wistar's Towne strain of CMV and related technologies. The Towne strain is an attenuated, or weakened, form of human CMV which was developed at Wistar for potential vaccine applications, and may be particularly useful in a prime-boost regimen with other prophylactic vaccines.

Through the VCU collaboration, Vical is exploring potential vaccine strategies that may provide broader protection against both fibroblast and epithelial cell CMV infections.

Vical's TransVax™ Therapeutic CMV Vaccine

CMV affects 30% to 60% of patients undergoing transplant procedures, causing transplant rejection, serious illness and even death if untreated. Expensive and toxic antiviral drug therapy is used to control the disease, but does not eliminate the infection. There is no approved vaccine against CMV. Protein-based vaccines that predominantly result in antibody responses to CMV may have limited effectiveness in transplant patients. Live, attenuated vaccines can induce both antibody and cellular immune responses, but pose a potential safety concern, particularly for immunocompromised patients, of causing the disease they are intended to prevent.

For transplant patients, Vical is developing TransVax™, a therapeutic DNA vaccine encoding the CMV gB and the pp65 antigens, and formulated with a poloxamer designed to enhance primarily a cellular immune response. Vical's TransVax™ vaccine has orphan drug designation for transplant patients. Vical announced promising interim results from an ongoing Phase 2 trial of the TransVax™ vaccine in patients undergoing hematopoietic stem cell transplants. The trial was completed in November 2009, and final results are expected in mid-2010.

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. Forward-looking statements include statements about Vical's technologies, the CyMVectin™ prophylactic vaccine, the Towne strain, the TransVax™ therapeutic vaccine, and the vaccine approaches being pursued in collaboration with VCU, as well as the company's focus, collaborative partners, and independent and partnered product candidates. Risks and uncertainties include whether Vical will enter into any development or commercialization collaborations for its CMV vaccine programs; whether Vical or others will continue development of CyMVectin™, Towne, TransVax™ or any other product candidates; whether the CyMVectin™ trial allowed by the FDA will be conducted; whether TransVax™ final Phase 2 trial data will be available in mid-2010, if at all; whether TransVax™ interim Phase 2 results will be predictive of final Phase 2 results; whether TransVax™ will achieve the safety and efficacy endpoints in the Phase 2 trial; whether Vical or its collaborative partners will seek or gain approval to market CyMVectin™, Towne, TransVax™ or any other 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:  Vical Incorporated
          Alan R. Engbring
          (858) 646-1127
          www.vical.com