NESS ZIONA, Israel, November 20,
2017 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV)
today announced the signing of the clinical trial agreement (CTA)
for a Phase 2 clinical trial with the National Institute of Allergy
and Infectious Diseases (NIAID) of the U.S. National Institutes of
Health (NIH).
The study is 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 Trivalent Influenza
Vaccine." It is designed to evaluate the cell mediated
immunity directly induced by BiondVax's universal flu vaccine
candidate M-001, as well as M-001's priming effect to enhance the
immunogenicity of current seasonal influenza vaccines.
Dr. Ron Babecoff,
BiondVax's CEO, commented, "We are honored to work with the
American NIH in their effort to improve protection from the flu,
one of the world's most common infectious diseases. We hope that
this important strategic collaboration will lead to additional
partnerships with other leading institutions."
BiondVax's Chief Science Officer Dr. Tamar Ben-Yedidia explained, "Along with our
successful European Union Phase 2b clinical trial results, this
current study will further explore the science behind M-001, our
innovative universal flu vaccine candidate. As part of the protocol
team, it has been an exciting experience working alongside the
field's leading experts from the NIAID. We are looking forward to
the day M-001 will be approved as a key component of influenza
prevention."
The NIAID-funded trial will include 120 young adults (aged 18 to
45 years) randomly assigned to one of two groups receiving either
placebo or M-001. Later, all participants will receive a currently
marketed unadjuvanted trivalent seasonal influenza vaccine. Four
trial sites from the NIAID-supported Vaccine and Treatment
Evaluation Units contracts are participating, namely Baylor College of Medicine in Texas, Cincinnati Children's Hospital Medical
Center in Ohio, and the
University of Iowa, with laboratory
support provided by St. Louis
University in Missouri[1]. The NIAID
is submitting the Investigational New Drug (IND) to the U.S. Food
and Drug Administration (FDA), and participant recruitment is
anticipated to begin after the end of the 2017/18 flu season.
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company developing a
universal flu vaccine. The vaccine candidate is designed to provide
multi-season protection against most seasonal and pandemic human
influenza virus strains. BiondVax's proprietary technology utilizes
a unique combination of conserved and common peptides from
influenza virus proteins, activating both arms of the immune system
for a cross-protecting and long-lasting effect. BiondVax is traded
on NASDAQ: BVXV and TASE: BVXV. Please visit
http://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, the results
of the contemplated Phase 2 & 3
trials, delays or obstacles in launching and/or
successfully completing our clinical trials, the impact
of the global economic environment on the Company customer target
base, 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, http://www.sec.gov,
and in the Company's periodic filings with the SEC
and the Tel-Aviv Stock Exchange.
Reference:
1. Contract numbers HHSN272201300015I,
HHSN272201300016I, HHSN272201300020I, and HHSN272201300021I,
respectively.
For further information, please contact:
BiondVax
Joshua Phillipson
+972-8-930-2529 x5105
j.phillipson@biondvax.com
SOURCE Biondvax Pharmaceuticals Ltd