SAN DIEGO, Feb. 1 /PRNewswire-FirstCall/ -- Vical Incorporated announced today that enrollment has opened in its novel Phase 2 trial of a DNA vaccine against cytomegalovirus (CMV). The Phase 2 trial will be conducted at leading U.S. transplant centers in donors and patients undergoing stem cell transplants. Success in this patient population would support Vical’s expansion of studies of its CMV vaccine into other transplant settings and into the general population.
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 completely eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV proliferation, potentially leading to severe illness or death. These include transplant patients who take immunosuppressive drugs, AIDS patients, and fetuses and newborns of mothers who first become infected during pregnancy.
Vaccine approaches that result in predominantly antibody responses to CMV have not proven highly effective in transplant patients. Vaccine approaches using live, attenuated viruses 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. Vical’s novel DNA vaccine approach is designed to induce both antibody and cellular immune responses against specific features of the CMV virus without the risk of causing CMV disease.
Because there currently is no approved CMV vaccine, Vical’s CMV vaccine has received Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for at-risk stem cell transplant and solid organ transplant populations. Vical also has been awarded $4.1 million in funding for its CMV vaccine program under three grants from the NIH.
“The emerging picture from a series of studies suggests that DNA vaccines effectively prepare the immune system for subsequent infection,” said David C. Kaslow, M.D., Vical’s Chief Scientific Officer. “Results from Phase 1 trials indicate that our CMV DNA vaccine can induce both cellular and antibody immune responses. This small Phase 2 trial will allow us to evaluate quickly the protective efficacy of our vaccine in a patient population subject to natural viral challenge.”
The company designed the double-blind, placebo-controlled Phase 2 trial with the support of transplant experts. Both donors and recipients will be vaccinated to maximize immune responses. Most recipients are expected to face a natural viral challenge as pre-existing CMV infection reactivates under immunosuppression. Safety of the vaccine will be compared against placebo in approximately 80 matched, related donor/recipient pairs (160 subjects total). Other important endpoints are the immune responses against the specific CMV features targeted by the vaccine, and the occurrence rate of clinically significant CMV levels in patients receiving active vaccine compared with patients receiving placebo. Further information on the trial is available through the company’s web site at www.vical.com or at the National Institutes of Health (NIH) clinical trials web site www.clinicaltrials.gov.
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 has retained all rights to its internally developed product candidates. 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 serve 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, including: whether the company will initiate the Phase 2 trial at leading transplant centers and successfully enroll 80 matched, related stem cell transplant donor/recipient pairs in a timely manner, if at all; whether the CMV vaccine will achieve the safety and efficacy endpoints in the Phase 2 trial for stem cell transplant donors and recipients; whether the company will expand development of a CMV vaccine into other transplant settings and into the general population; whether the vaccine will induce both antibody and cellular immune responses; whether the vaccine will prevent clinically significant CMV levels; whether Vical or its collaborative partners will seek or gain approval to market any 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.
Contacts: Investors: Media: Alan R. Engbring Susan Neath Vical Incorporated Porter Novelli Life Sciences 858-646-1127 858-527-3486 Website: www.vical.com
Vical Incorporated
CONTACT: investors, Alan R. Engbring of Vical Incorporated,+1-858-646-1127; or media, Susan Neath of Porter Novelli Life Sciences,+1-858-527-3486
Web site: http://www.vical.com/
