JERUSALEM, Nov. 18, 2019 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that
enrollment and randomization of 12,463 participants in the pivotal,
clinical efficacy, Phase 3 trial of the M-001 universal influenza
vaccine candidate is complete.
BiondVax's M-001 universal flu vaccine candidate is
designed as a common denominator to influenza A and B viruses.
Results from six completed human clinical trials indicate that
M‑001 is safe, well-tolerated, and induces an immune response to a
broad range of influenza strains. M‑001's single formulation is
intended to enable year‑round production, vaccination, and
stockpiling.
Dr. Tamar Ben-Yedidia,
BiondVax's Chief Scientific Officer, commented, "The pivotal
Phase 3 trial of our universal flu vaccine is being conducted for
two flu seasons over a broad geographic area in 12,463 older
adults, which is the group most urgently in need of improved
protection from the flu. The study will assess how well M-001
protects the participants against flu illness when they are exposed
to any circulating flu strain. We are grateful and impressed with
the CRO for the tremendous administrative and logistic achievement
enabling the recruitment and randomization of 12,463 people. We are
excited about the potential for M-001 to reduce illness and death
among older and elderly adults as well as reduce
influenza-associated health care costs."
The placebo-controlled, blinded, pivotal, clinical efficacy
Phase 3 trial will assess safety and effectiveness of the
M-001 vaccine alone in reducing flu illness and severity in 12,463
adults aged 50 years and older, including 6,291 (50.5%) aged 65 and
older. 4,042 people were enrolled and randomized in the trial's
first cohort prior to the 2018/19 flu season, and an additional
8,421 people were enrolled in the trial's second cohort (2019/20
flu season). 83 clinical trial sites in seven eastern European
countries enrolled participants. To assess the trial's primary
endpoint of safety and reduction of illness rates, the second
cohort's participants will be monitored for influenza-like illness
(ILI) symptoms throughout the upcoming flu season. Swabs will be
collected from those with ILI, and influenza confirmation will be
conducted by a qualified laboratory. As part of this Phase 3 study,
cell-mediated immunogenicity markers of M-001 will be evaluated in
a subset of participants. Results are expected by the end of
2020.
As previously reported, the European Medicines Agency (EMA)'s
Committee for Medicinal Products for Human Use (CHMP) reviewed the
trial design and allowed BiondVax to proceed. Regulatory
authorities in the seven countries in which the trial is being
conducted have also allowed the trial to proceed. Participants are
volunteers and have provided informed consent.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage
biopharmaceutical company developing a universal flu vaccine. The
vaccine candidate, called M-001, is designed to provide
multi-strain and multi-season protection against current and
future, seasonal and pandemic influenza. BiondVax's proprietary
technology utilizes a unique combination of conserved and common
influenza virus peptides intended to stimulate 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 clinical trials covering
698 participants, the vaccine has been shown to be safe,
well-tolerated, and immunogenic. The ongoing pivotal Phase 3
clinical trial aims to assess safety and effectiveness of M-001 in
reducing flu illness and severity. For more information, 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 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, timing and results of the ongoing
Phase 2 and Phase 3 trials and any subsequent trials; timing of
receipt of regulatory approval of our manufacturing facility in
Jerusalem; ability to demonstrate
the efficacy and safety of the vaccine; the timing of clinical
trials and marketing approvals; 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 U.S. Food and Drug Administration or equivalent foreign
regulatory agencies; the adequacy of available cash resources and
the ability to raise additional 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,
2018 filed with the U.S. Securities and Exchange Commission,
or SEC, which is available on the SEC's website, www.sec.gov. We
undertake no obligation to revise or update any forward-looking
statement for any reason.
Contact Details
Joshua E. Phillipson |
+972 8 930 2529 | j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.