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

VIENNA, Austria, January 13 /PRNewswire/ --

- 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

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
    E-mail: [email protected]
    AVIR Green Hills Biotechnology AG
    Gersthoferstrasse 29-31
    A-1180 Vienna
    Austria / Europe

    http://www.greenhillsbiotech.com

SOURCE AVIR Green Hills Biotechnology AG