Vical Presents Encouraging Preliminary Data From Final 12-month Follow-up in TransVax CMV Vaccine Phase 2 Transplant Recipient Trial
SAN DIEGO, April 22, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's TransVax™ cytomegalovirus (CMV) vaccine elicited sustained increases in both cellular and antibody immune responses compared with placebo through the final 12-month follow-up in an ongoing Phase 2 trial in hematopoietic cell transplant (HCT) recipients. Richard T. Kenney, M.D., Vical's Vice President of Clinical Development, is presenting the encouraging preliminary data today at the World Vaccine Congress (Washington – April 19-22).
"We were excited to see that our TransVax™ vaccine was able to enhance both T-cell and antibody responses to the encoded CMV antigens through the final 12-month data point," said Dr. Kenney, "and we are excited to see how these responses impact viral control. We also saw an encouraging boost in both T-cell and antibody responses after the fourth injection, which could prove important in controlling late-onset CMV reactivation. We expect to complete our analysis of the final trial data and report on our full evaluation of viral load and clinical endpoints in the third quarter."
TransVax™ 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™ is formulated with a proprietary poloxamer-based delivery system. The Phase 2 trial is evaluating the potential for TransVax™ 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 12-month immunogenicity analysis by group, TransVax™ continued to provide increased cellular immunological responses to both encoded CMV antigens, and increased antibody responses to gB, compared with placebo. TransVax™ 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 <http://www.globenewswire.com/newsroom/ctr?d=189386&l=6&a=www.vical.com&u=http%3A%2F%2Fwww.vical.com%2F> www.vical.com<http://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™ 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™ or any other product candidates; whether final Phase 2 trial data will be available in the third quarter, if at all; whether TransVax™ preliminary Phase 2 results will be predictive of final Phase 2 results; whether T-cell and antibody immune responses will help control CMV reactivation; whether a boost in T-cell and antibody responses after the final 6-month injection will help control late-onset CMV reactivation; whether TransVax™ will achieve the safety and efficacy endpoints in the Phase 2 trial; whether Vical or others will advance TransVax™ 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™ 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 Incorporated Alan R. Engbring (858) 646-1127 www.vical.com
Posted: April 2010