Avir Green Hills: Excellent Preclinical Data on Novel Type of Intranasal H5N1 Influenza Vaccine – Technology Also Suitable for Vaccination against Swine Flu

Business Wire, June 19, 2009

VIENNA -- Studies performed in three animal models confirmed the safety and intensive immunogenicity of a new type of intranasal H5N1 influenza vaccine, according to the latest preclinical study data announced today by the Vienna based firm, Avir Green Hills Biotechnology. The study data was just published in PloS One, the Public Library of Science.

“The intranasal immunization with our vaccine has proven itself capable of generating a strong immune response against H5N1 viruses. The technology, with which we produce the vaccine, once again has proven itself an especially successful path for future vaccines,” reports Dr. Thomas Muster, founder, CEO and CSO of Avir Green Hills Biotechnology. In addition to the intensive immune response, the tests in the animal models also showed long sustainable protection against different varieties of the virus. “Our approach is an attractive alternative to conventional influenza vaccines. Clinical evaluations of our pandemic and seasonal vaccine candidates are already in progress.”

Innovative technology for production and application

The process developed by Avir Green Hills Biotechnology for the creation of a vaccine against different influenza strains has several unique features compared to conventional flu vaccines:

• The application as nasal spray instead of injection into the muscle has an advantage in that the immunization protection is stimulated directly at the virus’ portal of entry. The simple practicability of such a spray is enormously advantageous, particularly in the case of pandemics in which circumstances might necessitate the inoculation of numerous people simultaneously.
• The novel vaccine can produce an effective immune reaction against the most distinct varieties of influenza viruses – something only conditionally possible with conventional vaccines. This so-called cross-protection also enables the warding-off of distantly related and already mutated strains of influenza viruses.
• Avir Green Hills has developed a completely novel technology: for the human organism the vaccine appears as a pathogenic flu virus. But it does not produce sickness because -- through a method developed by the Viennese firm -- the NS1 gene responsible for the pathogenic properties of the virus is first extracted from the vaccine, resulting in the deltaFLU vaccine. Thus, after intranasal administration of the vaccine, a strong immune response is stimulated that provides effective protection against the flu. This method provides for the greatest safety and a good tolerance.
• A fast, efficient method in the production of a vaccine, the method of reverse genetics developed by Avir Green Hills, makes it possible to produce a vaccine strain against myriad potential viruses within the shortest period of time: an important precondition for the rapid provision of vaccination in case of a pandemic.
• Avir Green Hills’ innovative vaccine ultimately is produced in cell cultures (vero cells) – a considerable advantage vis-à-vis conventional production using incubated chicken eggs.

“With this wealth of innovation, the vaccines of Avir Green Hills have the potential to secure a substantial share of the vaccine market,” notes Reinhard Zickler, the company’s chief legal officer.

Technology also suitable for swine flu vaccine

The latest study results are also of significance for the current H1N1 (swine flu) pandemic, Dr. Muster emphasized: “Our technology is applicable for every influenza subtype – including the current ‘new influenza’. The corresponding virus strain that we produced on the basis of the reverse genetics method is already finished and suitable for the vaccine production.” Next, the Viennese company plans as early as summer 2009preclinical testing and then the beginning of a clinical study on these vaccine candidates.

As early as the autumn of 2008, Avir Green Hills Biotechnology had been able to complete a clinical Phase I study on its seasonal H1N1 influenza vaccine that yielded excellent results on the safety of the vaccine and high immune response. The results of this trial will be published soon.

Excellent clinical data on the avian flu vaccine expected

The Vienna biotech company also reports important progress in the studies initiated in 2008 on the intranasal H5N1 vaccine especially applicable in the case of a pandemic. In Vienna and St. Petersburg, clinical studies (Phase I) involving the pandemic avian flu vaccine in a total of 68 healthy volunteers are currently in progress. Excellent results are expected. The final report of the Russian study is expected by the end of July this year. Data from the Vienna study should be available by the end of 2009.