US FDA grants IND to Bavarian Nordic, trial with IMVAMUNE™ smallpox vaccine in atopic dermatitis to start
Bavarian Nordic A/S announced today that the U.S. Food and Drug Association (FDA) has approved the company’s Investigational New Drug Application (IND) for its third-generation smallpox vaccine candidate to enter further clinical trials. Bavarian Nordic will immediately start a Phase l study with IMVAMUNE™, its safe third-generation smallpox vaccine, in 60 subjects including persons suffering from atopic dermatitis. This study will be conducted in Europe with the final report expected in 2005.
Persons with atopic dermatitis, more commonly known as eczema, are at risk in suffering potentially severe side effects from first and second generation smallpox vaccines. These persons as well as others in the known high-risk groups (immune compromised, pregnant, young, elderly, etc.) should not be given these vaccines.
Peter Wulff, President and CEO said, “With this latest IND, we will initiate, for the first time ever, a trial in a significant population of people that cannot safely receive the current smallpox vaccine. While the next phase in the US government’s MVA smallpox vaccine development programme (RFP-2 to be awarded in summer 2004) will require clinical trials in high-risk populations, we already have data on some risk groups from our recombinant vaccine development programme. Our decision to start this trial in atopic dermatitis now - rather than wait until RFP-2 is awarded – is based on our goal of registering IMVAMUNE™ as a safe smallpox vaccine for the general population as soon as possible.”
In addition and as reported last week, another Phase l trial with IMVAMUNE™ in 90 subjects is underway in the USA. This study will compare IMVAMUNE™ to the licensed smallpox vaccine DryVax® and will investigate whether the immune response against IMVAMUNE™ protects against a subsequent challenge with DryVax®. This trial is sponsored by the U.S. National Institute of Health and is expected to be completed in 2005.
The company will also start a Phase l trial in the third quarter of 2004, which will investigate IMVAMUNE™ in people with HIV. While Bavarian Nordic has already conducted trials in this risk group in Europe, it will be conducted again in the USA as a requirement of RFP-1. First results of this trial are expected in 2005.
