AURORA trial

Dynavax Reports Interim Analysis of Ongoing Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis

Retrieved on: 
Tuesday, April 28, 2020

Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis, showed HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.

Key Points: 
  • Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis, showed HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.
  • We are pleased with these interim results from the hemodialysis trial which reinforce the existing clinical data set regarding the safety and rates of protection provided by HEPLISAV-B, commented Robert Janssen , MD, Chief Medical Officer at Dynavax.
  • The study is designed to evaluate HEPLISAV-Bs immunogenicity at study week 20 and safety over the 68-week study duration.
  • Safety and effectiveness of a 4-dose regimen of HEPLISAV-B have not been established in adults on hemodialysis.

Health Canada has approved INVOKANA®* (canagliflozin) for reduction of major adverse cardiovascular events (MACE), the first SGLT2 inhibitor in Canada to receive this indication(1)

Retrieved on: 
Wednesday, October 17, 2018

** "Canadians living with diabetes have a higher risk for cardiovascular events, and addressing these risks is a key part of diabetes management.

Key Points: 
  • ** "Canadians living with diabetes have a higher risk for cardiovascular events, and addressing these risks is a key part of diabetes management.
  • INVOKANA now has demonstrated efficacy in reducing the risk of major adverse cardiovascular events among a broad population of patients."
  • The risk of amputation in CANVAS was 0.59/100 patient-years vs. 0.28/100 patient-years in the INVOKANA arm and the placebo arm, respectively.
  • INVOKANA is also approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.