Shiloh
Editor, Senior Moderator
Source: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/07-08-2008/0004845322&EDATE=
Start of Phase I Study for Intranasal Pandemic Influenza Vaccine deltaFLU
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
Start of Phase I Study for Intranasal Pandemic Influenza Vaccine deltaFLU
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