|
Bavarian Nordic announced today positive results in its global development programme of IMVAMUNE™ as a safe third-generation MVA smallpox vaccine. Results from the recently-completed Phase ll dose finding trial with IMVAMUNE™ in 165 healthy volunteers reconfirmed the strong safety and immunogenicity profile of the vaccine as reported from an earlier Phase I trial.
In this Phase ll trial, IMVAMUNE™ was found to have an excellent safety profile at all three dose levels tested. No serious adverse reactions were reported. Of the adverse reactions reported, the majority were mild-to-moderate injection site reactions.
More importantly these adverse events did not result in impairment of daily activities, indicating the superior tolerability of IMVAMUNE™ over traditional smallpox vaccines. In similar studies with traditional smallpox vaccines such as DryVax®, more than one-third of the subjects were sufficiently ill to miss work, school or recreational activities.
All volunteers who received the highest dose level of IMVAMUNE™ exhibited an excellent and rapid immune response, demonstrated by 94.2% sero-conversion after one vaccination and 100% after two vaccinations. Even more noteworthy was the immune response seen in the two low-dose groups. All subjects in these groups sero-converted after having received the full vaccination course. Further follow-up studies to evaluate the persistence of the immune response are planned.
Commenting on this latest development, Peter Wulff, President and CEO of Bavarian Nordic said, “The results of this Phase II study are very exciting and further justify the acceleration of our global clinical development of IMVAMUNE™. These results, along with our announcement last week to begin for the first time ever a Phase l trial with IMVAMUNE in atopic dermatitis, represent significant progress in our path to globally register IMVAMUNE™ as a safe third-generation smallpox vaccine for the general population, including the immune compromised.”
Copenhagen, 11 May 2004
Asger Aamund, Chairman of the Board
|
