NESS ZIONA, Israel, April 11,
2018 /PRNewswire/ -- BiondVax Pharmaceuticals
Ltd. (NASDAQ: BVXV) reported today the first participant
enrollment in the United States in
a Phase 2 clinical trial of the company's universal flu vaccine
candidate, M-001. The trial is sponsored by the US National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH). Conducted under an FDA
Investigational New Drug (IND), the trial marks M-001's clinical
debut in the United States.
Initially developed in Professor Ruth
Arnon's lab at the Weizmann Institute of Science in
Israel, M-001 is comprised of nine
epitopes common to influenza virus strains including both influenza
Type A and B. In six completed clinical trials in
Israel and Europe (two Phase 1/2 and four Phase 2),
BiondVax's universal flu vaccine candidate has been shown to be
safe, well-tolerated, and immunogenic to a broad range of influenza
strains.
As previously announced, a pivotal clinical efficacy Phase 3
trial is planned in Europe
later this year. Co-funded by the European Union's European
Investment Bank (EIB), the trial will enroll 9,630 participants
aged 50 years and older across four to six countries over a period
of two flu seasons.[1]
Dr. Ron Babecoff, BiondVax's CEO, commented, "We are
honored to be merging the world-renowned clinical and biomedical
expertise of NIAID-supported researchers with BiondVax's universal
flu vaccine development efforts. We are pleased to participate in
NIAID's focus on development of novel flu vaccines to improve
protection against current strains and protect against emerging
seasonal and pandemic threats."
The NIAID-sponsored study, titled "A Phase II, Double-Blind,
Multicenter, Randomized, Placebo-Controlled Trial to Assess the
Safety, Reactogenicity and Immunogenicity of Two Doses of
Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza
Vaccine" is being conducted at three sites (University of Iowa, Cincinnati Children's Hospital
Medical Center in Ohio, and
Baylor College of Medicine in
Houston, Texas), with laboratory
support by St. Louis University in
St. Louis, Missouri. These sites
are part of the NIAID-funded network of Vaccine and Treatment
Evaluation Units (VTEUs).
A total of 120 participants aged 18 to 49 years will be randomly
assigned to receive either two doses of M-001 or two doses of
a placebo, with the doses spaced several weeks apart. A few months
following the second injection, all participants will receive a
currently marketed unadjuvanted quadrivalent seasonal influenza
vaccine. Safety and immunogenicity will be assessed and compared
between the groups receiving M-001 and placebo.
Additional information regarding both the NIAID-sponsored Phase
2 trial and the pivotal clinical efficacy Phase 3 trial are
published on the clinicaltrials.gov website at
https://clinicaltrials.gov/ct2/show/NCT03058692, and
www.clinicaltrials.gov/ct2/show/NCT03450915, respectively.
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 2 and 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/2018/03/biondvax-appoints-cro-to-conduct-pivotal-clinical-efficacy-phase-3-trial-of-its-novel-universal-flu-vaccine-candidate/
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.