JERUSALEM, March 19, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) today issued an update
regarding the impact of the COVID-19 pandemic on the ongoing
pivotal, clinical efficacy, Phase 3 trial in Europe of the Company's M-001 universal
influenza vaccine candidate.
Dr. Ron Babecoff, BiondVax's President and CEO,
commented, "While to date the coronavirus pandemic has not
significantly impacted our Phase 3 clinical trial, we continue to
monitor the situation closely taking into account the best
interests of our employees, trial participants, health care
professionals, CRO staff and others involved in our trial. The flu
season in Europe is declining as
expected for this time of year, and most of the swab samples we
expected to obtain from participants exhibiting flu like symptoms
have already been collected. Nevertheless, we are continuing to
collect swab samples while adhering to restrictions imposed by
local authorities. As long as the pandemic situation does not
further significantly deteriorate, our CRO and statistician
currently expect us to reach the targeted number of swab samples.
We will continue to take all appropriate and feasible steps to
enable us to publish results by the end of this year."
Dr. Babecoff continued, "We wish all our stakeholders
and friends around the world good health as we strive to advance
our ongoing pivotal, clinical efficacy, Phase 3 trial of the M-001
universal influenza vaccine candidate."
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 7 completed Phase 1/2 and Phase 2 clinical trials
enrolling 818 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, risks relating to the COVID-19 pandemic, 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.