Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU
By Avir Green Hills Biotechnology Ag, PRNETuesday, January 12, 2010
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
VIENNA, Austria, January 14 - 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: i.bergmann@greenhillsbiotech.com AVIR Green Hills Biotechnology AG Gersthoferstrasse 29-31 A-1180 Vienna Austria / Europe
www.greenhillsbiotech.com
Contact: Isolde Bergmann, Cell: +43-664-8573403, E-mail: i.bergmann at greenhillsbiotech.com, AVIR Green Hills Biotechnology AG, Gersthoferstrasse 29-31, A-1180 Vienna, Austria / Europe
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