Full Press Release Details
BiondVax Phase 2b Trial Preliminary Safety
The Universal Flu Vaccine candidate is safe
Ness Ziona, Israel - November 29, 2016 -
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today
announced positive preliminary safety results from its European Phase 2b clinical trial of M-001, its universal flu vaccine candidate.
The trial is designed to compare safety and immunogenicity of M-001
between (1) a control group receiving saline as a placebo and then the standard H5N1 avian pandemic vaccine, and (2) an experimental
group receiving BiondVax's M-001 as a primer prior to receiving the same H5N1 pandemic vaccine. As the data is still blinded,
the distribution of adverse events between the total of 219 participants who completed the study in both the control and experimental
groups is unknown. Only 3 moderate adverse events were considered to be possibly or probably related to the treatment and no related
severe adverse events were reported.
Professor Shai Ashkenazi, recently appointed to BiondVax's
Scientific Advisory Board, who has guided multiple vaccines through clinical and regulatory approval phases to market, commented
that, "M-001 continues to display a remarkable safety profile. It is at least as safe, if not safer, than the current flu
vaccines. As we can see in the entire study population, both control and experimental groups, the total number of adverse events
is very low and mild."
The research leading to these preliminary results has received funding
from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n 602012. Conducted in collaboration
with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used
ahead of a pandemic influenza vaccine. BiondVax's European consortium partners are continuing humoral and cellular immune
response analysis, with results expected in the coming months.
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical
company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and
pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and
common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting
effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.
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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, results in Phase 2b clinical trials may not be indicative of results from later stage or larger scale clinical
trials, the adequacy of available cash resources to fund product development and commercialization, ultimate market acceptance
of the vaccine candidate, assuming approval and commercialization, and the ability to raise capital when needed. The risks, uncertainties
and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including
our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April
27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.