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www.fdanews.com/articles/75108-powdermed-launches-preclinical-avian-flu-vaccine-trial

POWDERMED LAUNCHES PRECLINICAL AVIAN FLU VACCINE TRIAL

August 5, 2005

PowderMed, an immunotherapeutics, has announced that it has progressed its H5N1 avian influenza vaccine program into the final stages of preclinical development.
PowderMed has produced an H5N1 vaccine by cloning the H5 gene from the current circulating avian flu strain into the company's proprietary DNA vaccine backbone and the vaccine is now ready for development. Manufacturing and toxicology studies are now in progress, and it is anticipated that this vaccine will enter clinical trials by the middle of 2006.
PowderMed has carried out a detailed feasibility study with contract manufacturing partners, which concludes that it could establish a manufacturing capability with a surge capacity of 150 million influenza vaccine doses in a three-month period. The avian flu vaccine uses the same standard DNA vaccine backbone as PowderMed's annual flu vaccine, which has already successfully completed a Phase I clinical trial and will enter Phase IIb trials in 2006.