BiondVax Announces Receipt of Ethics ("Helsinki") Committee Approvals for the Initiation of first Phase II Clinical Trial for Universal Influenza Vaccine
Ness Ziona, Israel - 17 August 2010 - BiondVax Pharmaceuticals Ltd. (TASE: BNDX), an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a universal influenza vaccine, today announced that it has received the approvals of the Ethics ("Helsinki") Committees of the Institutional Review Boards (IRB) of both the Hadassah Clinical Research Center at Hadassah University Hospital in Jerusalem ("Hadassah") and the Tel Aviv Sourasky Medical Center ("Ichilov"), to perform a Phase II clinical trial to evaluate the safety and immunogenicity of BiondVax's universal influenza vaccine candidate, the Multimeric-001.
Both Hadassah and Ichilov are internationally recognized medical facilities that have vast experience in the conduct of clinical trials. The principal investigators conducting the clinical trial will be Prof. Yoseph Caraco, Director of the Clinical Research Center at Hadassah and Dr. Jacob Atsmon, Director of the Clinical Research Center at Ichilov.
The trial is designed to include a total of 160 participants, both male and female, 18-49 years old, who will be divided into three groups: a treatment group of 80 participants that will receive the 500mcg adjuvanted formulation of the Multimeric-001 vaccine, and two control groups of 40 participants each, that will receive adjuvanted and non-adjuvanted placebo formulations, respectively.
Screening of the potential participants will commence immediately, with the first administrations of the vaccine expected to take place in October 2010. The Company expects to be able to report headline results from this trial by the end of the second quarter of 2011.
Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientific Officer, said, "We are very pleased to have received the necessary approvals for the initiation of our first Phase II clinical trial. We are looking forward to commencing the trial in October, and to continuing our progress towards the successful development of the world's first truly universal influenza vaccine."
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About BiondVax Pharmaceuticals Ltd.
BiondVax Pharmaceuticals, a publicly-traded company (TASE: BNDX) based in Ness Ziona, Israel, is developing a proprietary, innovative Universal Influenza ("flu") Vaccine, the Multimeric-001, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal influenza strains and pandemic influenza strains, such as Swine flu and Avian flu.
BiondVax's technology utilizes a unique, proprietary combination of conserved epitopes from influenza virus proteins to activate the immune system for a cross-protecting and long-lasting effect.
BiondVax has recently successfully concluded two Phase I/II clinical trials for the Multimeric-001 vaccine. The vaccine was shown to be safe and immunogenic in both trials. The first Phase II clinical trial is scheduled to commence in the second half of 2010.
For further information on BiondVax, please visit www.biondvax.com