Nes Ziona, Israel – June 17, 2015 – BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration (FDA), and the Company was notified by its regulatory advisors that the ‘study may proceed’. FDA acceptance of an IND provides authorization for the distribution and administration in the U.S. of medical products that have not yet been approved for commercial use for purposes of conducting clinical trials.
This IND continues BiondVax’s clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax’s product candidate.
Dr. Ron Babecoff, BiondVax’s CEO commented, “FDA acceptance of our IND application is an important milestone, representing a major step forward for BiondVax and for the development program of our universal flu vaccine.”
Dr. Tamar Ben-Yedidia, BiondVax’s CSO said, “Influenza is a serious global concern – it spreads rapidly, leading to serious illness which can directly or indirectly lead to death, particularly among the elderly. Today’s vaccines are far from ideal – they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness. We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year.”