NESS ZIONA, Israel, Dec. 27,
2017 /PRNewswire/ -- BiondVax Pharmaceuticals
Ltd. (Nasdaq: BVXV, TASE: BVXV) announced today that the
European Medicines Agency (EMA)'s Committee for Medicinal Products
for Human Use (CHMP) reviewed BiondVax's Phase 3 trial plan,
provided advice, and allowed the Company to proceed with the Phase
3 clinical trial plan for M-001, BiondVax's universal flu vaccine
candidate. The CHMP advice will facilitate procedures in the
countries where the Phase 3 study will take place.
The CHMP response states that, "It is agreed 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."
Dr. Tamar Ben Yedidia,
BiondVax's Chief Science Officer noted, "According to our expert
European advisors, the CHMP accepts the entire approach in general
and the study design in particular. This means BiondVax can proceed
to Phase 3 as planned."
Dr. Ron Babecoff, CEO of BiondVax, commented, "I wish
to thank the EMA's CHMP for their thoughtful and informative advice
which we are incorporating into BiondVax's pivotal Phase 3 trial
plan."
Babecoff continued, "There is a clear need to improve
upon current flu vaccine technologies, as noted in the recent
New England Journal of Medicine article titled Chasing Seasonal
Influenza — The Need for a Universal Influenza
Vaccine.[1] BiondVax's Universal Flu Vaccine candidate
is designed to address challenges of current flu vaccines such as
mismatches, mutations, and long production lag. With six completed
successful human clinical trials, we are excited to proceed to a
pivotal clinical efficacy Phase 3 trial with M-001 as a universal
flu vaccine."
The placebo-controlled pivotal clinical efficacy Phase 3 trial
plans to enrol a total of 7,700 participants over two years. Since
assessment of clinical efficacy of influenza vaccines largely
depends on the attack rates of circulating influenza strains, the
study features flexible enrollement to adjust the required number
of participants in year 2. The participants will be aged 50 years
and older, with at least half over 65 years of age.
The trial is expected to take place in Eastern Europe and begin prior to the 2018/19
flu season.
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
and TASE: 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 risk that drug
development involves a lengthy and expensive process with uncertain
outcome, whether preliminary or interim results from a clinical
trial will be predictive of the final results of the trial; whether
results obtained in clinical trials such as the results referenced
in this release will be indicative of results that will be
generated in future clinical trials; 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] Paules, CI, et al "Chasing Seasonal Influenza - The
Need for a Universal Influenza Vaccine," The New England Journal
of Medicine. November 29, 2017,
http://www.nejm.org/doi/full/10.1056/NEJMp1714916 (accessed
December 27, 2017).
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