Recent Updates
Recently added Catalysts
SCNI

Announces Intent to Launch a Phase 2 Trial in the

Key Takeaway: Announces Intent to Launch a Phase 2 Trial in the States in Collaboration with the U.S. National Institutes of Health Ziona, Israel - September 2, 2015 - BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced the intent of the National Institute of Allergy an

Full Press Release Details

Announces Intent to Launch a Phase 2 Trial in the
States in Collaboration with the U.S. National Institutes of Health
Ziona, Israel - September 2, 2015 - BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced the
intent of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH)
within the Department of Health and Human Services (HHS), to launch a new phase 2 trial to be held in the United States in the
2015-16 timeframe. The trial will examine the use of BiondVax's universal flu vaccine candidate, Multimeric-001 (M-001),
as a primer vaccine, which would be administered several weeks before a pandemic vaccine. The trial will be a collaboration between
BiondVax and the National Institute of Allergy and Infectious Diseases.
trial will assess the ability of M-001 in humans to serve as a pandemic primer to the H7N9 avian pandemic vaccine, by enhancing
protective immunity to these highly pathogenic avian influenza H7 strains. It will also look to strengthen previous clinical and
pre-clinical findings on M-001 priming capacity to other seasonal and pandemic strains.
a strain-specific flu vaccine for a pandemic outbreak takes 4-6 months to manufacture, a period during which the virus can spread
rapidly, causing high levels of illness and mortality. Stockpiling of M-001 as a pandemic primer would enable vaccination schedules
to start immediately upon any pandemic declaration.
is currently producing the M-001 vaccine batch for this clinical trial.
Babecoff, BiondVax's President and CEO, commented, "The recognition of the potential of our technology by a foremost
public health authority in the United States, is a significant milestone in our clinical development program. This trial will
assess our vaccines' ability to be used as the stockpiled flu vaccine for pandemic protection. The scenario is that immediately
following a flu pandemic outbreak of any strain, our vaccine could be used from day zero, saving multiple lives and limiting the
wild spread of a flu pandemic. This collaboration with NIAID brings us a significant step closer to our Phase 3 clinical trial."
Ben-Yedidia, BiondVax's Chief Scientific Officer, commented, "This important trial is examining the use of M-001
in the event of an H7 avian influenza outbreak. It is complementary to a previous clinical trial in the elderly that concluded
successfully, showing enhanced immunogenicity against the H1N1 swine pandemic virus in participants that received our M-001 vaccine
as primer. This study is also complementary to our upcoming European clinical trial in which the M-001 will serve as a primer
to the H5N1 avian pandemic vaccine."
BiondVax Pharmaceuticals Ltd
is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain
protection against most human influenza virus strains, including both seasonal and pandemic flu strains.
technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate
both arms of the immune system for a cross-protecting and long-lasting effect.
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, uncertainty of clinical
trial results or regulatory approvals or clearances, final results from subsequent clinical trials, risks inherent in the
development and commercialization of potential products, dependence upon collaborators, and adequacy of capital resources for
product development and commercialization. The risks, uncertainties and assumptions referred to above are discussed in detail
in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May
11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
further information, please contact:
Last updated: Sep 2, 2015