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.