NESS ZIONA, Israel, March 13,
2018 /PRNewswire/ -- BiondVax Pharmaceuticals
Ltd. (Nasdaq: BVXV), developer of the Universal Flu Vaccine
candidate M-001, announced today the signing of a Master Service
Agreement (MSA) with a contract research organization (CRO) to
conduct the first pivotal, clinical efficacy, Phase 3 trial of
M-001.
Originally conceived in the lab of Professor Ruth Arnon at the Weizmann Institute of Science
in Israel, M-001 is comprised of
nine epitopes common to the vast majority of influenza virus
strains including both influenza Type A and B. In M-001's six
successful completed clinical trials (two Phase 1/2 and four Phase
2) to-date, it has been shown to be safe, well-tolerated, and
immunogenic to a broad range of influenza strains.
BiondVax's pivotal, clinical efficacy, Phase 3 trial is planned
to begin later this year, prior to the 2018/19 Northern Hemisphere
flu season. 9,630 participants aged over 50 years will be enrolled
across four to six countries in eastern Europe. The trial is expected to follow
participants for up to two flu seasons. The European Medicines
Agency (EMA)'s Committee for Medicinal Products for Human Use
(CHMP) previously reviewed BiondVax's Phase 3 trial plan, and
accepts the entire approach in general and the study design in
particular, thus enabling the Company to proceed. The CHMP stated
that "a single pivotal efficacy trial that provides a robust
demonstration of efficacy against laboratory-proven influenza like
illness (ILI) could suffice for an approval."[1]
Dr. Tamar Ben-Yedidia,
BiondVax's Chief Science Officer (CSO), commented, "Having
worked on our universal flu vaccine since the very beginning and
ushering it through many years of R&D and clinical trials, I am
particularly proud to reach this exciting milestone. As far as we
know, this is the world's most clinically advanced universal flu
vaccine. This winter's flu season shows us once again the urgent
need for an improved flu vaccine. I hope our vaccine will
contribute to significant reduction of the economic and social
burden of influenza."
Additional information regarding the pivotal, clinical efficacy
Phase 3 trial is published on clinicaltrials.gov website:
www.clinicaltrials.gov/ct2/show/NCT03450915.
About BiondVax Pharmaceuticals Ltd
BiondVax is an advanced clinical stage biopharmaceutical company
developing a universal flu vaccine. The vaccine candidate, called
M-001, is designed to provide multi-season protection against
current and future, seasonal and pandemic influenza virus strains.
BiondVax's proprietary technology utilizes a unique combination of
conserved and common influenza virus peptides, activating both arms
of the immune system for a cross-protecting and long-lasting
effect. In a total of 6 completed Phase 1/2 and Phase 2 human
clinical trials, covering 698 participants, the vaccine has been
shown to be safe, well-tolerated, and immunogenic. BiondVax is
traded on NASDAQ: BVXV. Please visit 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
prosecution and outcome of the Phase 3 trials, the risk that
drug development involves a lengthy and expensive process with
uncertain outcome; the ability of the Company to maintain, preserve
and defend its intellectual property and patents granted; whether
our vaccine candidate will successfully advance through the
clinical trial process on a timely basis, or at all, and receive
approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies; the
adequacy of available cash resource and the ability to raise
capital when needed. More detailed information about the risks
and uncertainties affecting the Company is contained under the
heading "Risk Factors" in our Annual Report on Form 20-F for the
year ended December 31, 2016 filed
with the U.S. Securities and Exchange Commission, or SEC, which is
available on the SEC's website, www.sec.gov, and in the
Company's periodic filings with the SEC and the Tel-Aviv Stock
Exchange.
[1]
http://www.biondvax.com/2017/12/biondvax-plans-phase-3-clinical-trial-following-receipt-of-scientific-advice-from-the-european-medicines-agency-ema/
For further information, please contact:
BiondVax
Joshua
Phillipson
+972-8-930-2529 x5105
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.