Vical's TransVax CMV Vaccine Elicits Long-Term Immune Responses in Phase 2 Trial
SAN DIEGO, Oct. 7, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's TransVax(TM) cytomegalovirus (CMV) vaccine continued to demonstrate an overall increase in cellular immune responses compared with placebo at the seven-month immunogenicity data point in an ongoing Phase 2 trial. Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, presented the data today at the World Vaccine Congress (Lyon, France - October 5-8).
"T-cell responses are very important in protecting recovering transplant recipients against CMV disease," said Dr. Rolland, "and we were pleased to see that the T-cell responses to both CMV antigens encoded by our vaccine, noted in our four-month interim analysis, were sustained through the seven-month data point. In addition, we saw a promising emerging trend in the antibody response against CMV after the last of four scheduled injections. We look forward to reviewing the final trial data in the first half of 2010."
TransVax(TM) is a bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) for induction of cellular and humoral immune responses. TransVax(TM) is formulated with a proprietary poloxamer-based delivery system. The Phase 2 trial is evaluating the potential for TransVax(TM) to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. At the seven-month immunogenicity analysis by group, TransVax(TM) continued to provide increased cellular immunological responses to both encoded CMV antigens compared with placebo. TransVax(TM) has received orphan drug designation for HCT and solid organ transplant patients.
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.
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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 Vical's technologies, the TransVax(TM) vaccine against CMV reactivation, as well as the company's focus, collaborative partners, and independent and partnered product candidates. Risks and uncertainties include whether Vical or others will continue development of TransVax(TM) or any other product candidates; whether final Phase 2 trial data will be available in the first half of 2010, if at all; whether TransVax(TM) interim Phase 2 results will be predictive of final Phase 2 results; whether TransVax(TM) will achieve the safety and efficacy endpoints in the Phase 2 trial; whether Vical or others will advance TransVax(TM) to Phase 3 testing; whether such testing, if conducted, will be successful; whether Vical or its collaborative partners will seek or gain approval to market TransVax(TM) or any other DNA-based human vaccine or therapeutic 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 Alan R. Engbring (858) 646-1127 www.vical.com
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Posted: October 2009