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Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU
Date:1/13/2010

The clinical phase II study will be carried out with GHB11L1, an improved H1N1 vaccine developed by AVIR Green Hills. This vaccine is expected to trigger an even better immune response than the one tested in previous phase I studies while being equally safe and well tolerated. The concomitant analyses will be done at the Institute of Virology at the Medical University of Vienna.

Publication of phase I study results

AVIR Green Hills Biotechnology is proud to announce that the clinical data obtained in the phase I deltaFLU study will be published in the renowned "Journal of Infectious Diseases" on 15 January 2010. The article describes the first in-man study and hence the first clinical application of the novel, intranasal, seasonal H1N1 influenza vaccine deltaFLU.

The successful phase I study showed that the H1N1 vaccine was well tolerated and safe. Moreover, it proved that the deltaFLU influenza vaccination induces an immune response in the body. Another piece of very good news is that it was possible to demonstrate the induction of cross-protective immunity against other influenza virus strains.

"The results of the clinical phase I study are excellent. This vaccine guarantees maximum safety and tolerance. We also expect outstanding results regarding safety, local and systemic immune responses in the phase II study," says Thomas Muster, founder and CEO of AVIR Green Hills Biotechnology.

Novel influenza vaccine

The deltaFLU vaccine is characterized by the deletion of its pathogenicity factor NS1 (i.e. the viral defense mechanism against the cellular immune response), which renders the vaccine viruses replication-deficient (i.e. they cannot multiply). This makes the vaccine very safe. The other important effect is that it triggers a very strong immune response.


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SOURCE AVIR Green Hills Biotechnology AG
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