NESS ZIONA, Israel, November 29,
2016 /PRNewswire/ --
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
http://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, 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.
For further information, please contact:
Joshua E Phillipson
Business Development
+972-8-930-2529 x5105
j.phillipson@biondvax.com
Kenny Green
Investor Relations
+1-646-201-9246
kenny@biondvax.com
SOURCE BiondVax Pharmaceuticals Ltd.