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2004 SEP 20 - (NewsRx.com & NewsRx.net) -- International biopharmaceutical company Bavarian Nordic announced key developments.
Bavarian Nordic noted particular progress has been made to date on their safe, third generation smallpox vaccine program in the U.S.:
1) The U.S. Food and Drug Administration (FDA) granted Bavarian Nordic an Investigational New Drug (IND) application for Imvamune to enter further clinical trials. The first-ever trial with Imvamune in persons with atopic disorders (ie. eczema) is underway.
2) Results from a phase II study showed that Imvamune has an excellent safety profile at all three dose levels tested. All study volunteers sero-converted after two vaccinations at all doses.
3) Bavarian Nordic submitted its proposal on RFP-2 to the National Institute of Health (NIH) in February. The award announcement is expected in September 2004.