Full Press Release Details
Results Show that BiondVax's Universal Flu Vaccine
Administered in a Trial 3 years ago Improves Immunogenicity against
Current Flu H3N2 Epidemic
Ness Ziona, Israel - August 3, 2015
- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced it received the statistical analysis of results
from a study which demonstrates that BiondVax's universal flu vaccine (M-001), administered in the BVX-005 phase II trial
which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the
time of the study- in particular the current newly emerged H3N2 influenza (flu) strain that caused the epidemic in the United States
In 2012, 120 elderly participants aged 65 or
over, participated in the BVX-005 trial. This trial was concluded successfully, demonstrating induction of both humoral and cellular
immune responses to BiondVax's vaccine and to multiple influenza viruses. In that trial, 90 participants were injected with
the M-001 universal flu vaccine a few weeks prior to immunization with TIV (the commercially available seasonal flu vaccine of
that time). The remaining group of 30 was a control group which was provided with a placebo followed by the TIV.
Three years later, in 2015, BiondVax exposed
the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza
flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist.
BiondVax examined the immunogenicity (HAI)
antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain
in the samples taken from participants that received the M-001 vaccine in comparison to the control group. An average of 50% or
greater of the participants in the experimental group receiving M-001 showed immunogenicity against this new strain versus only
10% on average in the control group, a result which has statistically high significance.
This concurs with the similar results found
in BiondVax's recent BVX-006 phase II trial, showing increased antibody response to the H3N2 epidemic flu strain in those that
received BiondVax's universal vaccine, although it was not included in the commercially available seasonal flu vaccine of
the 2014/15 season. Management believe that this data confirms the universal nature of BiondVax's vaccine, protecting against all
types of flu strains.
Ron Babecoff, BiondVax's President
and CEO, commented, "We are happy that the participants which received our vaccine in the trial three years ago present
a higher immunogenicity, even to actual flu strains in circulation now. The independently provided statistical analysis we reported
today is very important as it demonstrates that M-001 provides a safety net by broadening the immunogenicity to existing and future
flu strains - in this case, against a specific flu strain that back when the trial was conducted, did not yet exist. If our vaccine
was approved by the necessary regulatory bodies and available in the market during the last winter, we believe that the recent
epidemic could have been prevented. These results are another important data point showing the importance of our work for global
public health and in particular for the elderly which are most vulnerable to this dangerous virus."
About BiondVax Pharmaceuticals Ltd
BiondVax 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.
BiondVax's 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.
Forward Looking Statements
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.
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