Full Press Release Details
FDA Acceptance of IND Application for its
Investigational Universal Flu Vaccine
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
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."
About BiondVax Pharmaceuticals Ltd
BiondVax is an innovative biopharmaceutical
company developing a universal flu vaccine, designed to provide multi-season and multi-strain protection against most human influenza
virus strains, including both seasonal and pandemic flu strains.
BiondVax's technology utilizes
a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate both arms of the
immune system for a cross-protecting and long-lasting effect.
Weizmann Science Park, 14 Einstein Street,
PO Box 4143, Nes Ziona 7414002, Israel
Tel: +972 8 930 2529 Fax:+972 8 930 2531 www.biondvax.com
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe,"
"intend," "plan," "continue," "may," "will," "anticipate," and similar
expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties
reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties
and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals
Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process
with uncertain outcome, adequate resources to undertake and complete the Phase 2 clinical trials and the success thereof, our estimates
regarding the vaccine's future development and expected trials, the market acceptance of our flu vaccine as a broad-coverage solution
and adequacy of capital resources for product development and commercialization. The risks, uncertainties and assumptions referred
to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which
was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking
For further information, please contact:
Weizmann Science Park, 14 Einstein Street,
PO Box 4143, Nes Ziona 7414002, Israel
Tel: +972 8 930 2529 Fax:+972 8 930 2531 www.biondvax.com