NESS ZIONA, Israel, March 13,
2017 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE:
BVXV), a clinical stage biopharmaceutical company focused on
developing and commercializing M-001, a universal flu vaccine
candidate, reports the publication this week of an article by
BiondVax-affiliated authors titled, "Strategy for approving
a universal flu vaccine" in the peer reviewed
journal Future Virology.
The article proposes a process for regulatory and marketing
approval for next-generation influenza vaccines such as M-001.
Current flu vaccines are strain-specific, and existing regulatory
approval pathways are not directly applicable to M-001's unique
method of action, which is designed to protect against current and
future seasonal and pandemic flu strains.
The authors propose a step-wise regulatory strategy in which the
novel vaccine is initially approved for use prior to flu season and
followed, when available, by currently recommended strain-specific
vaccines. Applied in this manner, human clinical trials have shown
M-001 broadens and enhances the action of current flu vaccines.
This is of particular importance for the elderly who, despite high
seasonal flu vaccination rates suffer disproportionately from flu
illness. Ultimately, based on clinical efficacy trials, M-001 will
be approved as a standalone flu vaccine, potentially replacing
existing seasonal strain-based vaccines.
Dr. Tamar Ben-Yedidia,
BiondVax's Chief Scientist and the article's lead author,
commented, "In many ways, our universal flu vaccine candidate is
blazing a trail. Heeding messages from European and American
regulatory experts, we have identified what we believe to be the
safest and most efficient path for bringing M-001 to the market.
Publication in a peer-reviewed journal is a strong sign of support
for our plans."
The Future Virology article is available for free to
registered users via Infectious Diseases Hub at
https://www.id-hub.com/2017/03/09/strategy-approving-universal-flu-vaccine/.
The article complements a recently published article in
Vaccine which discusses M-001's mechanism of action.
(http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/).
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
uncertainty of the regulatory approval process, the results of
the current Phase 2
and contemplated Phase 3
trials, general business conditions in the industry, changes
in regulatory and legal compliance environments in which BiondVax
engages, 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
SOURCE BiondVax Pharmaceuticals Ltd.