Start of Phase I Study for Intranasal Pandemic Influenza Vaccin...( VIENNA Austria July 8 /- Avir Gre...),Health

VIENNA, Austria, July 8 /PRNewswire/ -- Avir Green Hills Biotechnology starts a clinical phase I study with its intranasal vaccine deltaFLU against pandemic influenza. This novel generation of a live-attenuated vaccine based on the deletion of the NS1 gene has shown superior preclinical data. In taking this step, the Viennese biotech company sets yet another milestone in the development of effective and safe vaccines.

Aim of Phase I Study

The randomized, double-blind phase I study of the pandemic vaccine deltaFLU will be run at the Department of Clinical Pharmacology, Medical University of Vienna. The aim of phase I study is to analyze the safety and efficacy of the vaccine in healthy volunteers.

Preclinical Data, Pandemic Vaccine

"Our vaccine lacks the pathogenicity factor NS1. Due to this deletion, the vaccine is likely to show a superior safety profile. We are confident that the pandemic deltaFLU vaccine will be tolerated even at high doses," comments Thomas Muster, founder and CEO/CSO of Avir Green Hills Biotechnology.

Outstanding preclinical data show an excellent immune response even against distantly related pandemic H5 strains (cross-protection). Moreover, a long lasting immune response - an important prerequisite for an effective vaccine - was observed.

"We are very pleased about the success of our vaccine in the preclinical studies. The data are superb and exceed our highest expectations," reports Andrej Egorov, who is Vice President for Research at Avir Green Hills Biotechnology and one of the leading experts in the field of live attenuated influenza vaccines.

The novel influenza vaccine deltaFLU

differs from a conventional influenza vaccine in three major characteristics and in the method of production:

1. Nasal Spray

The vaccine is administered intranasally with a spray device instead of being injected into a muscle. This approach offers the major advantage of stimulating the v
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