Astellas And Vical Begin Phase 2 Trial Of ASPO113 Vaccine
Astellas Pharma Global Development, Inc. and Vical Inc. have begun a Phase 2 trial of ASP0113 in approximately 140 solid organ transplant (SOT) recipients. ASP0113 (formerly TransVaxä) is an investigational bivalent DNA vaccine containing plasmids (closed loops of DNA) that induce both cellular and humoral immune responses. The vaccine has previously received orphan drug designation in the United States and Europe for the prevention of CMV disease in hematopoietic cell transplant (HCT) and SOT patients. Orphan drug designation is granted to drugs which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
The global, randomized, double-blind, placebo-controlled trial is designed to evaluate the effectiveness of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. The study will also measure the safety of ASP0113 among these patients. Follow-up for each subject will continue for one year following the study. CMV is a herpes virus that infects more than 50% of adults in the United States by age 40, with a higher incidence in developing countries. A healthy immune system will protect an infected person against CMV disease, but does not prevent or clear latent infection, and those with compromised immune systems are at high risk of CMV reactivation, potentially leading to severe illness or death. Transplant patients are among those in the highest risk group for the virus.
Under an exclusive global license agreement with Vical, Astellas is conducting the trial to develop and commercialize ASP0113. Vical is providing development, regulatory and manufacturing support. Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
Source: Wall Street Journal