Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 301

The Vaccine Proves Safe and Activates Immunity to Flu

Posted by fidest press agency su venerdì, 17 febbraio 2012

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Nes Ziona, Israel (PRNewswire)BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced positive results from its second Phase II clinical trial (BVX-005) of the Universal Influenza Vaccine (Multimeric-001) developed by Biondvax for improving existing flu vaccines in elderly. The vaccine was found to be safe and well tolerated, and induced robust cellular and humoral immune responses in elderly patients (65+), successfully meeting the primary safety and secondary immunogenicity endpoints. In addition, when given as a primer before boosting with a commercially available seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), Multimeric-001 vaccine enhanced the performance of the TIV by increasing immunity to influenza strains contained in the TIV (“prime-boost” regimen). The Multimeric-001 vaccine improved immunity to influenza in the elderly without the need for any adjuvant. The effectiveness of priming with Multimeric-001 was determined by means of hemagglutination inhibition (HAI) assays. HAI-based immune measures are utilized by US and European regulatory authorities to approve and license existing influenza vaccines.
The elderly are a growing population at high risk for influenza and currently under protected. For example in the US, elderly adults constitute 15% of the population but account for 65% of hospitalizations and 90% of deaths attributable to influenza and its complications. This reflects weakening immune systems and the limited immunity provided to the elderly by TIVs. Indeed, of the approximately 350 million elderly worldwide vaccinated with a seasonal TIV each year (about 70% of the total seasonal flu vaccine market), up to 210 million do not respond sufficiently and are not protected against the strains contained in the TIV. Innovative approaches are urgently required to improve protection against influenza among the elderly and hence, to reduce influenza-related morbidity and mortality and associated high economic burden.
This Phase II trial was a randomized, double-blind, placebo-controlled study in 120 elderly (65+) volunteers conducted at two clinical research centers in Israel – the Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center. In light of the successful conclusion of this second Phase II clinical trial in the elderly in Israel, BiondVax is preparing to conduct a third Phase II trial in the elderly in Europe. This trial is expected to commence in the third quarter of 2012 and to be concluded in the first quarter of 2013.
Biondvax`s estimates regarding the future development of the vaccine and expected trials with respect to the vaccine are forward looking information based on the information that Biondvax has in its possession today pertaining to the potential of the vaccine`s development. These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including the failure to reach the objectives of the trials and/or schedules and/or to obtain the necessary funding for the continuation of development of the vaccine as well as other factors which are not within Biondvax’s control and the materialization of any of the risk factors detailed in Section 5.27 of Biondvax`s shelf prospectus published on January 17, 2012.
BiondVax Pharmaceuticals (“Biondvax”), a publicly-traded company (TASE: BNDX) based in Nes Ziona, Israel, is developing a proprietary, innovative Universal Influenza (“flu”) Vaccine, the Multimeric-001 vaccine, designed to provide multi-season and multi-strain protection against many human influenza virus strains, including both seasonal and pandemic influenza strains.

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