BiondVax Announces Receipt of IRB Ethics (“Helsinki”) Committee Approvals for the Initiation of Second Phase II Clinical Trial for Universal Influenza Vaccine
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BiondVax Pharmaceuticals Ltd., has 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, immunogenicity and priming potential of BiondVax’s universal influenza vaccine candidate, the Multimeric-001.
The principal investigators conducting the clinical trial will be Prof. Yoseph Caraco, Director of the Hadassah Clinical Research Center (CRC) and Dr. Jacob Atsmon, Director of the Ichilov CRC.
The trial is designed to include a total of 120 participants, both male and female, 65 years of age and older.
Screening of the potential participants will commence immediately, with the first administrations of the vaccine expected to take place in October 2011.
The Company expects to be able to report headline results from this trial by the end of the first quarter of 2012.
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 second Phase II clinical trial, which follows the successful completion of our first Phase II trial a few months ago. We are looking forward to continuing our progress towards the successful development of the world’s first truly universal influenza vaccine.”