VIENNA, Austria, July 8 Avir-Green
VIENNA, Austria, July 8 /PRNewswire/ -- Avir Green Hills Biotechnology
starts a clinical phase I study with its intranasal vaccine deltaFLU against
pandemic influenza. This novel generation of a live-attenuated vaccine based
on the deletion of the NS1 gene has shown superior preclinical data. In
taking this step, the Viennese biotech company sets yet another milestone in
the development of effective and safe vaccines.
Aim of Phase I Study
The randomized, double-blind phase I study of the pandemic vaccine
deltaFLU will be run at the Department of Clinical Pharmacology, Medical
University of Vienna. The aim of phase I study is to analyze the safety and
efficacy 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 confident
that 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 even
against distantly related pandemic H5 strains (cross-protection). Moreover, a
long lasting immune response - an important prerequisite for an effective
vaccine - was observed.
"We are very pleased about the success of our vaccine in the preclinical
studies. The data are superb and exceed our highest expectations," reports
Andrej Egorov, who is Vice President for Research at Avir Green Hills
Biotechnology and one of the leading experts in the field of live attenuated
influenza vaccines.
The novel influenza vaccine deltaFLU
differs from a conventional influenza vaccine in three major
characteristics and in the method of production:
1. Nasal Spray
The vaccine is administered intranasally with a spray device instead of
being injected into a muscle. This approach offers the major advantage of
stimulating 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 vaccine
stimulates a strong immune response, which offers protection against
influenza. In other words, the vaccine "fakes" an infection that induces an
immune response without causing illness.
3. Cross-Protection
The vaccine can induce an effective immune response against a wide range
of influenza virus variants, which is only conditionally possible with
conventional vaccines. This cross-reactivity can also provide protection
against distantly related "drift variants" of pandemic influenza strains.
4. Cell-Based Production Method
The technology used by Avir Green Hills Biotechnology comprises a modern
production method in cell cultures and does not rely on traditional egg-based
manufacturing. In addition, Avir Green Hills Biotechnology has optimized the
method of reverse genetics, which permits the generation of a vaccine against
any potential influenza virus within a very short period of time. This might
be essential for a timely response in pandemic situations.
Avir Green Hills Biotechnology Inc.
Avir Green Hills Biotechnology Inc. is a biopharmaceutical company based
in Vienna, founded in 2002. Avir Green Hills Biotechnology's core competence
is the development of innovative, therapeutic and prophylactic products
against viral infections and cancer. "Our strength is our extensive know-how
in virology and our network of renowned national and international partners
in academia and industry," says Joachim Seipelt, Co-Founder and Vice
President for Cooperation at Avir Green Hills Biotechnology.
After completion of phase I clinical trials, Avir Green Hills
Biotechnology will start clinical phase II studies with the pandemic and the
seasonal deltaFLU vaccines in 2009. Subsequently, Avir Green Hills
Biotechnology plans to perform a phase III challenge trial against seasonal
influenza, which will allow early proof of efficacy. These studies will
provide the basis for phase III field trials leading to market authorization.
Press photos & movies
http://www.greenhillsbiotech.com/news.html
Contact
Isolde Bergmann (Corp. Communications)
mobile: +43-664-8573403
mail: i.bergmann@greenhillsbiotech.com
Avir Green Hills Biotechnology AG
Gersthofer Strasse 29-31
A-1180 Vienna
Austria - Europe
http://www.greenhillsbiotech.com
SOURCE Avir Green Hills Biotechnology Trade AG
