SAN DIEGO, March 2, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the receipt of Scientific Advice from the European Medicines Agency (EMA) recommending practical efficacy endpoints for a Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine. Because the incidence of CMV disease is low and the target population—recipients of hematopoietic cell transplants—is small, the EMA agreed with the company's position that a CMV disease endpoint is not practical. The EMA also provided positive comments on important features of the proposed trial design and overall product development pathway.
Vical is currently evaluating plans for the pivotal Phase 3 trial with the U.S. Food and Drug Administration (FDA). The company will provide additional information about the trial upon completion of regulatory agency discussions, and expects to begin the planned Phase 3 trial in the second half of 2011.
Vical's TransVax™ Therapeutic CMV Vaccine
To address the unmet need to protect transplant patients from CMV reactivation, Vical is developing TransVax™, a therapeutic DNA vaccine encoding the CMV glycoprotein B (gB) antigen and the CMV phosphoprotein 65 (pp65) antigen, and formulated with a poloxamer designed to enhance plasmid delivery and protein expression, resulting primarily in an increased cellular immune response. Vical's TransVax™ vaccine has U.S. orphan drug designation for transplant patients. In September 2010, Vical announced statistically significant immunogenicity and clinical efficacy results with no safety issues from a completed Phase 2 trial of the TransVax™ vaccine in patients undergoing hematopoietic stem cell transplants.
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. 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.
About Scientific Advice
Scientific Advice is a process offered by the EMA to help companies to make sure they perform the appropriate tests and studies to avoid major objections during evaluation of subsequent marketing authorization applications. The advice is given in light of current scientific knowledge, based on documentation provided by the company. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support a marketing authorization application. Scientific advice received from the EMA is not legally binding on the EMA or on the company.
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 .
The Vical Incorporated logo is available at
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 planned Phase 3 trial of the TransVax™ therapeutic CMV vaccine in transplant recipients 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 the FDA will concur with the Scientific Advice provided by the EMA; whether the proposed TransVax™ Phase 3 trial design will be allowed by regulatory authorities, and if so, whether the trial will begin in the second half of 2011, if at all; whether Vical or its collaborative partners will seek or gain approval to market 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: Alan R. Engbring (858) 646-1127 Website: www.vical.com