Pevion Biotech, the Swiss vaccine company, today announced that it has successfully completed the preclinical safety and efficacy studies of its RSV vaccine candidate PEV4. The vaccine candidate is a modern subunit vaccine candidate against respiratory syncytial virus (RSV), which is based on a recombinant RSV-F protein formulated with Pevion Biotech's proprietary and market-validated virosome technology platform. RSV continues to be a major problem, affecting both the young and the elderly in particular. RSV is responsible for over 900,000 hospitalizations annually in the US and Europe. The results of these studies will be presented at the Vaccine Innovation Meeting in Frankfurt, Germany on April 29, 2010.
“Among the numerous studies on RSV vaccines I have reviewed, the positive results of the PEV4 vaccine were particularly impressive with regard to the unusually high degree of protection as well as the excellent reproducibility within various independent studies.”
Pevion Biotech has successfully demonstrated the safety and efficacy of its RSV vaccine candidate in three independent studies carried out at different institutions. The studies showed with high reproducibility that either two or three injections given in three-week intervals with two different doses of RSV-F antigen formulated with virosomes were able to induce high levels of neutralizing antibodies. The immunized animals (mice and cotton rats) were challenged with live RSV to test for protective efficacy of the vaccine candidate. PEV4 prevented the occurrence of severe disease, and vaccinated animals quickly recovered from the virus challenge in contrast to unvaccinated animals. Moreover, animals vaccinated with PEV4 showed a strongly reduced virus load in their lungs in comparison to untreated control animals.
Prof. Peter JM Openshaw, Director of the Centre for Respiratory Infection, Imperial College London, and renowned RSV expert made the following assessment: "Among the numerous studies on RSV vaccines I have reviewed, the positive results of the PEV4 vaccine were particularly impressive with regard to the unusually high degree of protection as well as the excellent reproducibility within various independent studies."
Pevion Biotech is developing an RSV vaccine especially for elderly people, who have increased safety and efficacy needs. According to CEO Dr. Thomas Stauffer, PEV4 can be extended to other vulnerable subpopulations: "The immune response in a population with a waning or compromised immune system needs to be particularly smoothly boosted. Such vulnerable populations demand a modern vaccine demonstrating high tolerability and safety in addition to the required efficacy. Already clinically validated in a number of studies, virosome-based subunit vaccines fulfill these requirements. As an added bonus, the RSV PEV4 vaccine could also be used in combination with other vaccines for the same population."
Due to the beneficial outcome of the preclinical efficacy studies of the vaccine and the proof of concept in the animal model, Pevion Biotech expects to enter a first clinical trial in 2011/2012.
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