Spring 2017 - Safety

C.Diff Vaccine Shows Promise in Phase II Trial

Results of a Phase II clinical trial of Pfizer’s preventive vaccine against Clostridium difficile (C. diff) showed the vaccine was safe and stimulated a C. diff targeted immune response. PF-06425090 is a three-dose recombinant vaccine designed to stimulate an antibody against the two main toxins (A and B) produced by C. diff, which cause the characteristic diarrhea and colitis caused by the bacteria. The results clear the way for the vaccine to enter a Phase III trial in the first half of 2017. Pfizer also has another C. diff vaccine in development, VLA84, which successfully completed Phase II trials in France last July. The company is now seeking a partner to help fund a Phase III study. In addition, Sanofi has an ongoing Phase III trial of a C. diff toxoid vaccine based on inactivated toxins A and B, which started in 2013 and generated positive Phase II data in 2014. That vaccine is predicted to reach the market in 2019.

References

  1. Taylor P. Chasing Sanofi, Pfizer Tees Up Phase 3 Trials for C.Diff Vaccine. Fierce Biotech, Jan. 27, 2017. Accessed at www.fiercebiotech.com/biotech/chasingsanofi-pfizer-tees-up-phase-3-trials-for-c-diff-vaccine.
BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.