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Start of Phase I Study for Intranasal Pandemic Influenza Vaccine deltaFLU

Wednesday, July 9, 2008 General News J E 4
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VIENNA, Austria, July 8 Avir Green Hills Biotechnologystarts a clinical phase I study with its intranasal vaccine deltaFLU againstpandemic influenza. This novel generation of a live-attenuated vaccine basedon the deletion of the NS1 gene has shown superior preclinical data. Intaking this step, the Viennese biotech company sets yet another milestone inthe development of effective and safe vaccines.

Aim of Phase I Study

The randomized, double-blind phase I study of the pandemic vaccinedeltaFLU will be run at the Department of Clinical Pharmacology, MedicalUniversity of Vienna. The aim of phase I study is to analyze the safety andefficacy 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 confidentthat 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 evenagainst distantly related pandemic H5 strains (cross-protection). Moreover, along lasting immune response - an important prerequisite for an effectivevaccine - was observed.

"We are very pleased about the success of our vaccine in the preclinicalstudies. The data are superb and exceed our highest expectations," reportsAndrej Egorov, who is Vice President for Research at Avir Green HillsBiotechnology and one of the leading experts in the field of live attenuatedinfluenza vaccines.

The novel influenza vaccine deltaFLU

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

1. Nasal Spray

The vaccine is administered intranasally with a spray device instead ofbeing injected into a muscle. This approach offers the major advantage ofstimulating the vaccine protection directly at the site of virus entry.

2. Effective Immune Response

Though the vaccine looks like a pathogenic influenza virus to the body,it does not cause disease. However, after intranasal application, the vaccinestimulates a strong immune response, which offers protection againstinfluenza. In other words, the vaccine "fakes" an infection that induces animmune response without causing illness.

3. Cross-Protection

The vaccine can induce an effective immune response against a wide rangeof influenza virus variants, which is only conditionally possible withconventional vaccines. This cross-reactivity can also provide protectionagainst distantly related "drift variants" of pandemic influenza strains.

4. Cell-Based Production Method

The technology used by Avir Green Hills Biotechnology comprises a modernproduction method in cell cultures and does not rely on traditional egg-basedmanufacturing. In addition, Avir Green Hills Biotechnology has optimized themethod of reverse genetics, which permits the generation of a vaccine againstany potential influenza virus within a very short period of time. This mightbe essential for a timely response in pandemic situations.

Avir Green Hills Biotechnology Inc.

Avir Green Hills Biotechnology Inc. is a biopharmaceutical company basedin Vienna, founded in 2002. Avir Green Hills Biotechnology's core competenceis the development of innovative, therapeutic and prophylactic productsagainst viral infections and cancer. "Our strength is our extensive know-howin virology and our network of renowned national and international partnersin academia and industry," says Joachim Seipelt, Co-Founder and VicePresident for Cooperation at Avir Green Hills Biotechnology.

After completion of phase I clinical trials, Avir Green HillsBiotechnology will start clinical phase II studies with the pandemic and theseasonal deltaFLU
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