SAN DIEGO, Oct. 3, 2013 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the publication of a new article1 in a special DNA vaccine issue of the journal Vaccines detailing the development process from initial product concept to Phase 3 trial initiation for ASP0113 (TransVax™), Vical's investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in transplant recipients. Vical and Astellas Pharma Inc. (TSE:4503) ("Astellas") entered into exclusive worldwide license agreements in 2011 to develop and commercialize ASP0113.
"Vical has been a pioneer in the development of DNA vaccines since the discovery of plasmid DNA utility in the late 1980s," said Larry R. Smith, Ph.D., Vice President, Vaccine Research at Vical and lead author of the new publication. "The recent initiation of the Phase 3 trial of ASP0113 marks a major achievement for the company and a significant milestone in the vaccine field. We are particularly pleased to share the recognition for this important 'first' with our partners at Astellas who have assumed responsibility for the advancement of ASP0113. We are excited by the potential to address a serious medical need for immunosuppressed transplant patients whose recovery is threatened by CMV."
The multinational Phase 3 registration trial of ASP0113 was initiated in June 2013 and is expected to enroll approximately 500 hematopoietic cell transplant (HCT) recipients. Astellas is conducting the trial, and Vical is providing development, regulatory and manufacturing support. Astellas expects to begin a separate Phase 2 trial of ASP0113 in solid organ transplant (SOT) recipients later this year.
ASP0113 is an investigational bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding human CMV pp65 and gB antigens for induction of both cellular and humoral immune responses. ASP0113 is formulated with a proprietary poloxamer-based delivery system. ASP0113 has received orphan drug designation in the United States and Europe for HCT and SOT patients.
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. A healthy immune system typically protects an infected person against CMV disease, but does not prevent or clear latent 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 distinct vaccine approaches for these separate market segments: ASP0113 for the transplant market and CyMVectin™ for the congenital disease market.
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 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.
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 ASP0113 CMV vaccine and its potential to address medical needs for immunosuppressed transplant patients, clinical trial plans and timelines, as well as the company's focus, licensees, and independent and partnered product candidates. Risks and uncertainties include whether Vical, Astellas or others will continue development of ASP0113 or any other product candidates; whether Astellas will begin a Phase 2 trial of ASP0113 in SOT recipients later this year, if at all; whether the Phase 3 and Phase 2 trials of ASP0113 will be completed, and if so, whether results will support further development or commercialization; whether Astellas will successfully develop and commercialize ASP0113; whether Vical will provide assistance to Astellas with manufacturing, regulatory and development activities; whether Astellas will reimburse all, if any, of Vical's ASP0113-related costs; whether Vical or its licensees will seek or gain approval to market ASP0113 or any other DNA-based human vaccine or therapeutic product candidates; whether Vical or its licensees 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 companies' judgment as of the date of this release. The companies disclaim, however, any intent or obligation to update these forward-looking statements.