November 6, 2008
Bavarian Nordic Reports Encouraging Safety Data From Phase II HIV Study
Bavarian Nordic, an industrial biotechnology company, has completed a clinical safety report from a large Phase II study with Imvamune in HIV infected subjects that confirms the excellent safety profile of Imvamune.
Within the next few days the safety report of this study will be submitted to the FDA and this will trigger a $25 million milestone payment under the RFP-3 contract. The clinical safety report constitutes a major part of the data package that will be used to potentially support the use of Imvamune in a declared emergency, the company said.
In support of using Imvamune as a smallpox vaccine in individuals otherwise contraindicated to receive conventional vaccinia vaccines, Bavarian Nordic has performed a large Phase II study in HIV infected subjects with CD4 counts between 200 and 750cells/microl to compare the safety to healthy subjects.
The safety report from this study includes data from over 300 HIV infected and 86 healthy subjects, all of whom had no history of prior smallpox vaccination. The low number of adverse events confirmed the favourable safety profile of Imvamune in vaccinia-naive HIV infected subjects with varying degrees of immune suppression.
According to the company, there was no difference in adverse events between the healthy and HIV infected subjects, even in the most immune compromised patients (CD4 counts greater than or equal to 200-350 cells/microl).
The complete data set from this trial is expected to be reported in the second half of 2009. The final report will include data on immunogenicity as well as long-term (six-month) safety information and will contain data from subjects enrolled in an additional study arm funded by the National Institutes of Health under RFP-2 (HIV infected subjects with a history of previous exposure to a conventional smallpox vaccine).