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2004 JUN 2 - (NewsRx.com & NewsRx.net) -- Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (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.
Peter Wulff, president and chief executive officer said, "With this latest IND, we will initiate, for the first time ever, a trial in a ...
Source: HighBeam Research, Imvamune smallpox vaccine clinical study to include eczema patients.