Start Of Phase Ii Study For Intranasal, Seasonal Influenza Vaccine Deltaflu

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15th January 2010, 06:49pm - Views: 1057

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Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU

VIENNA, Jan. 14 / PRNewswire-AsiaNet / --


    - By Starting the Phase II Study for deltaFLU, AVIR Green Hills AG has Accomplished yet Another

Milestone in the Development of this Novel Influenza Vaccine. Completion of this Clinical Phase II Study is

Envisaged for Spring 2010

    - The Positive Results Obtained in the Previous Clinical Phase I Study will be Published in the Renowned

"Journal of Infectious Diseases" on 15 January 2010

    AVIR Green Hills Biotechnology, the innovative biotech company based in Vienna, has started the New

Year by embarking on the first clinical phase II study for the seasonal vaccine deltaFLU. The study will be

carried out at the Medical University of Vienna. With this step, AVIR Green Hills has set yet another important

milestone in the development of effective and modern influenza vaccines.

    Start of clinical phase II study

    In a randomized double blind study, the vaccine will be administered intranasally to 48 volunteers.

    "In double blind studies, neither the administering physician (and/or the commissioning party) nor the

volunteers know who gets the placebo. Moreover, none of them knows which sprays contain the tested

vaccine and which contain the placebo," explains Franz Groiss, who is in charge of managing clinical studies

at AVIR Green Hills Biotechnology. The study will be headed by Volker Wacheck and carried out at the

Department of Clinical Pharmacology at the Vienna General Hospital.

    Aim of phase II study

    The aim of the phase II study is to optimize the vaccine dose and to substantiate the efficiency of the

vaccine and its ability to trigger an immune response.

    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

People Feature AVIR Green Hills Biotechnology AG 3 image

    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.

    The vaccine is administered as nasal spray instead of being injected. It is produced in cultured cells (Vero

cells). This process permits automated production in bioreactors and can easily be scaled in line with the

respective demand.

    "Our new generation of live attenuated vaccines offers optimized effectiveness and combines high safety

and maximum efficiency," explains Andrej Egorov, Vice President Research at AVIR Green Hills and one

of the leading experts on live attenuated influenza vaccines.

    Plans for the future

    In 2010, AVIR Green Hills Biotechnology plans to run another clinical phase II study in Vienna to test the

seasonal vaccine H1N1 in persons above age 65. Other studies in the pipeline are those for a monovalent

H3N2 and B vaccine, which will be followed by a study for the trivalent vaccine H1N1, H3N2 and B.

    In the first quarter of 2010, AVIR Green Hills Biotechnology expects to have the data from the completed

phase I study for the pandemic H5N1 vaccine deltaFLU, which was also carried out at the Department of

Clinical Pharmacology at the Vienna General Hospital.

    AVIR Green Hills Biotechnology AG

    AVIR Green Hills Biotechnology is a biopharmaceutical company based in Vienna, Austria. It was founded

in 2002 and currently has a staff of 50 employees. The company's core competence is the development of

innovative vaccines against viral infections and cancer.

    The deltaFLU development is supported by two research projects funded by the European Union in the 6th

framework program (projects FLUVACC and Intranasal H5 Vaccine). These projects led by AVIR Green Hills

Biotechnology combine expertise of a renowned international consortium comprising national and international

research partners.


    Contact: Isolde Bergmann

    Cell: +43-664-8573403


    AVIR Green Hills Biotechnology AG

    Gersthoferstrasse 29-31

    A-1180 Vienna

    Austria / Europe

    SOURCE: AVIR Green Hills Biotechnology AG


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