NESS ZIONA, Israel, September 21,
2016 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced
today that the last participant in a European Phase 2b clinical
trial of M-001, its universal flu vaccine candidate, has completed
their final visit. 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.
"This important milestone marks the conclusion of the patient
facing part of our European trial. Laboratory analysis is now
underway, and we look forward to the results in the coming months.
The conclusion of this trial, along with the upcoming start
of our NIH-sponsored Phase 2 trial in the USA, means we are on track to be Phase 3 ready
in the 2017/18 timeframe. We are excited to be one step closer to
bringing our multi-strain and multi-season vaccine against seasonal
and pandemic flu to the market," explained BiondVax's Chief
Scientist, Dr. Tamar Ben-Yedidia.
In 2009, following the official World Health Organization (WHO)
declaration of a H1N1 swine flu pandemic, it took about 6 months
until vaccines against the new strain could be administered. During
those 6 months the pandemic proliferated, ultimately killing up to
575,000 people globally[1].
The long delay is attributable to current egg-based
manufacturing processes and the need for the new vaccine to be
highly specific to the new pandemic flu strain.
To mitigate against the 6-month delay some authorities currently
stockpile pandemic flu vaccines. For example, under the U.S.
Department of Health and Human Services (HHS) Pandemic Influenza
Plan, one of the key goals for vaccine preparedness is to
"stockpile vaccines against influenza viruses with pandemic
potential to cover 20 million
persons."[2]
However, given current flu vaccine technology, each different
flu strain requires its own specific vaccine. As well, there is an
unlimited number of potential future flu strains. BiondVax's flu
vaccine, M-001, is advantageous in that it is designed to
provide protection against a broad range of current and
future potential flu strains.
The current trial in Europe is
designed to compare humoral and cellular immune response between
two groups. These are (1) a control group receiving the standard
avian pandemic vaccine alone, and (2) a group receiving BiondVax's
M-001 as a primer prior to receiving the pandemic vaccine.
The goal following its approval for use as a pandemic primer
would be to administer stockpiled M-001 immediately upon
declaration of any new pandemic, thereby providing broad flu
protection until a virus-specific vaccine is produced a few months
later. BiondVax's long-term intent is to license M-001 as a
standalone universal flu vaccine, replacing both the current
seasonal and pandemic vaccine technology.
-
http://www.cdc.gov/flu/spotlights/pandemic-global-estimates.htm,
retrieved 19 Sept 2016.
-
https://www.medicalcountermeasures.gov/barda/pandemic-influenza.aspx,
retrieved 19 Sept 2016.
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, the results
of the current Phase 2
& contemplated phase 3 trials, the
adequacy of available cash resources to fund product development
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.