ASP0113, an investigational DNA vaccine developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) patients, has failed to meet its primary and secondary endpoints in results from the phase III HELIOS trial.1
In the phase II trial, the safety profiles were generally similar between treatment groups, but local injection site reactions were more common in the ASP0113 treatment group.
- Astellas and Vical Announce Top-Line Results for Phase 3 Trial of Cytomegalovirus Vaccine ASP0113 in Hematopoietic Stem Cell Transplant Recipients. Astellas Pharma Inc. and Vical Incorporated. Published and accessed January 18, 2018. https://www.astellas.com/en/corporate/news/pdf/eg_fin_180122.pdf.
- Vical and Astellas Announce Topline Results from a Phase 2 Study of Investigational Cytomegalovirus (CMV) Vaccine (ASP0113) in Kidney Transplant Patients. Astellas Pharma Inc. and Vical Incorporated. Published September 19, 2016. Accessed January 18, 2018. http://bit.ly/2n1MSwS.
... to read the full story