AmVac AG

Preclinical Data Support the Potential of AmVacs RSV Vaccine
Innovative approach to the prevention of severe respiratory infections

Zug (ots) - AmVac AG has announced that it has made decisive progress in the development of their new RSV vaccine. The vaccine candidate is based on AmVac's innovative Sendai virus vector platform and developed for the prevention of respiratory infections, which are induced by RSV (respiratory syncytial virus).

RSV is one of the most common causes of bronchiolitis and pneumonia and the most common reason for hospitalisation of children worldwide. Overall, in the seven largest pharmaceutical markets, more than 18 million people are affected by severe RSV infections.

In close cooperation with the internationally recognised expert on RSV, Prof.ssa Grazia Cusi and her team from the Institute of Virology at the University of Siena, Italy, AmVac has recently recorded excellent preclinical data on the efficacy and safety of its innovative RSV vaccine. Furthermore, the partners have successfully completed the evaluation of different vaccine types and selected a particularly promising candidate (AMV602) for further development. In relevant model systems it was shown that AMV602 induces a stable immune protection against RSV. It activates both of the body's own defense mechanisms: first, the humoral immune response, in which antibodies play a central role, and second, the cellular immune system with helper and cytotoxic T cells as the main actors.

This balanced activation of the body's own defense mechanisms distinguishes the AmVac vaccine candidate quite clearly from all the other projects in this field that have been developed and tested. Most of them were discontinued because of adverse effects, which were mainly due to a one-sided activation of the immune system.

"Our results indicate that our vaccine is not only very effective but also very safe and well tolerated. For the first time millions of people who currently cannot be treated effectively, could be protected preventively," said Melinda Karpati, CEO of AmVac AG.

At present, an expensive antibody therapy, which is of limited effectiveness, is the only treatment option. According to Datamonitor, an effective, ambulatory deployed RSV vaccine could reduce the number of cases and deaths significantly and achieve peak sales of more than one billion U.S. dollars.

AmVac will continue to develop its vaccine candidate AMV602 rapidly and plans to begin clinical trials before the end of 2013.

About AmVac

AmVac AG is a biopharmaceutical company that develops and markets innovative vaccines. With headquarters in Switzerland, research laboratories in Germany and Italy as well as a production facility in Hungary, the company concentrates leading European expertise in its field. AmVac's portfolio currently includes five vaccine candidates and three platform technologies - Gynevac, Sendai and MALP - that are licensed out to a Hungarian partner and top German institutes in the Helmholtz and Max Planck Societies. AmVac's leading product has already been approved for selected indications and regions and is currently widely developed for the treatment of particularly frequent urogenital diseases. With its incomparably high safety profile it was able for the first time to provide an effective and virtually side-effect free therapy or prevention of benign prostatic hyperplasia (BPH), prostatitis, bacterial vaginosis and trichomoniasis. Other vaccine candidates are currently in preclinical development. Target indications are respiratory infections, as well as seasonal and pandemic influenza.

Contact:

AmVac AG
Metallstrasse 4
6300 Zug/Switzerland
Tel.: +41/41/725'32'30
E-Mail: ir@amvac.eu



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