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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.
4) Global manufacturing and marketing collaboration with GlaxoSmithKline on Imvamune established.
5) The U.S. Patent and Trademark Office (PTO) issued a patent to Bavarian Nordic on MVA-BN. The patent covers the MVA-BN virus and derivatives thereof exhibiting similar properties, including its use as a smallpox vaccine (Imvamune), and vector technology for development of recombinant vaccines for the prevention and treatment of other diseases.
Source: HighBeam Research, Progress reported in smallpox vaccine development.