AVIR Green Hills Biotechnology commences deltaFLU Phase II study

Jan 18 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

The Positive Results Obtained in the Previous Clinical Phase I Study will be Published in the Renowned "Journal of Infectious Diseases" on 15 January 2010

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.