Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU
– 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
January 2010
AVIR Green Hills Biotechnology, the innovative biotech company based in
study for the seasonal vaccine deltaFLU. The study will be carried out at the
Medical University of
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
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
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
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
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
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
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
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
http://www.greenhillsbiotech.com
SOURCE AVIR Green Hills Biotechnology AG