Successful Phase I/II Clinical Trial for BiondVax Pharmaceuticals' Universal Flu Vaccine

By Biondvax Pharmaceuticals Ltd, PRNE
Sunday, December 6, 2009

BiondVax's Multimeric-001 Universal Flu Vaccine was Found to be Safe and to Activate Both Arms of the Human Immune System, Inducing an Elevated Level of Antibodies in all Participants

RECHOVOT, Israel, December 7 -

    - 60 people, males and females, aged 18-49, participated in the trial
    - The antibodies generated by the vaccine specifically identified several
      strains of influenza, including the swine flu strain
    - BiondVax's CEO Dr. Ron Babecoff: "This is an important indication along
      the way towards the realization of the Company's vision of ensuring
      protection against all flu strains with a single vaccination."

BiondVax Pharmaceuticals Ltd. (www.biondvax.com/) (TASE: BNDK), an
Israeli biopharmaceutical company at the forefront of the development of
a Universal Influenza Vaccine, announced the success of the Phase I/II
clinical trial of the Company's Multimeric-001 Universal Flu Vaccine, in
trials conducted at the Sourasky Medical Center in Tel Aviv, Israel. The
Phase I/II trial was a randomized, single-blind, placebo-controlled,
escalating double-dose safety study in which a total of 60 participants,
males and females aged 18-49, received two intramuscular injections
containing the Multimeric-001 vaccine, either with or without adjuvant,
and at two different dose levels.

The clinical trial results show that BiondVax's Multimeric-001 Universal
Flu Vaccine is safe to use at all doses tested, both with and without
adjuvant.

In addition, it was found that the Multimeric-001 Universal Flu Vaccine
activated, in a statistically significant manner when compared with
placebo, the two arms of the human immune system - the humoral (antibody)
arm and the cellular arm. All participants who received the vaccine
showed a high level of antibodies against the Multimeric-001 Universal
Flu Vaccine. These antibodies also specifically identified a number of
different strains of influenza, including the swine flu strain (A/H1N1).

In this Phase I/II clinical trial, certain cellular parameters were
examined, and it was found that the Multimeric-001 Universal Flu Vaccine
caused, in a statistically significant manner when compared with placebo,
a meaningful increase in the white blood cells of the immune system,
inducing the secretion of Interferon Gamma and Interleukin-2, substances
secreted by the immune system as part of the body's cellular defense
against pathogens. This cellular response distinguishes BiondVax's
Multimeric-001 Universal Flu Vaccine from existing seasonal flu vaccines,
which are characterised mainly by their ability to stimulate a humoral
(antibody) response.

Furthermore, it was found that BiondVax's Multimeric-001 Universal Flu
Vaccine stimulated both humoral (antibody) and cellular responses against
the two types of influenza: Influenza Type A and Influenza Type B, the
types of flu which cause the flu disease in humans. This is in contrast
to other universal vaccines that are currently under development, which,
to the Company's best knowledge based on scientific publications and
other sources, are intended to provide protection against Type A
influenzas only.

In the clinical trial it was found, in a statistically significant manner
when compared with placebo, that the highest immunogenicity was observed
when using the highest dose of the Multimeric-001 Universal Flu Vaccine
with adjuvant, which was injected twice to the participants. Similarly,
it was found that in the dose given twice without adjuvant, there was a
statistically significant response.

This trial is the first of two Phase I/II clinical trials of the
Multimeric-001 Universal Flu Vaccine being conducted by BiondVax - the
second trial has already commenced with 60 participants aged 55-75, and
is expected to be completed in the first quarter of 2010.

Dr. Ron Babecoff, BiondVax CEO
(www.biondvax.com/128084/Executive-Management-1), notes that "We
are very proud of the success of the Phase I/II clinical trial for the
Multimeric-001 Universal Flu Vaccine, and of this initial proof of the
immunogenicity and safety of our vaccine. The results obtained in this
trial are an important indication of a significant milestone towards the
realization of the Company's vision of ensuring protection against all
flu strains through the use of a single vaccine. Such a vaccine is
expected to do away with the need for annual vaccinations every year as
required by current existing vaccines."

Dr. Tamar Ben Yedidia, BiondVax's Director of R&D
(www.biondvax.com/128084/Executive-Management-1), notes that, "the
success of the trial proved that the Multimeric-001 Universal Flu Vaccine
is safe to use and activates both arms of the human immune system. This
is an important achievement, which will continue to be tested thoroughly
in further clinical trials that will be conducted".

Dr. Ben Yedidia will be presenting this data at the World Influenza
Congress in Brussels, Belgium
(www.terrapinn.com/2009/flu/SPK-dr-ron-BABECOFF.stm), on 8
December 2009
, in a presentation entitled "Delivering an Epitope-based
Approach to Universal Influenza Vaccine Development".

Notes to Editors

About BiondVax Pharmaceuticals Ltd.

BiondVax Pharmaceuticals ("the Company"), a publicly-traded company
(TASE: BNDK) based in Rechovot, Israel, is developing a proprietary,
innovative Universal Influenza ("flu") Vaccine, the Multimeric-001
vaccine, with the potential to provide multi-season and multi-strain
protection against most human influenza virus strains, including both
seasonal influenza strains as well as pandemic influenza strains, such as
Swine flu and Avian flu.

BiondVax's Universal Flu Vaccine is based on research carried out over a
period of 20 years by Weizmann Institute Professor Ruth Arnon, who heads
the Company's Scientific Advisory Board. Professor Arnon is well-known
for her part in the development of Copaxone(R), a blockbuster drug for
the treatment of multiple sclerosis. The Company holds a worldwide
exclusive license granted by Yeda Research and Development Ltd., the
commercial arm of the Weizmann Institute, Israel, for developing,
manufacturing and commercializing this innovative Universal Flu Vaccine.

BiondVax is currently testing its lead product, the Multimeric-001
vaccine, in two Phase I/II clinical trials.

BiondVax's team includes scientists, technicians, researchers, and
administrative staff. The Company's state-of-the-art GMP facility,
located in the Weizmann Science Park in Rechovot, houses its
laboratories, production facilities, and offices.

For further information on BiondVax, please visit the Company's website:
www.biondvax.com

For logos, pictures and other company information please visit:
www.biondvax.com/128084/Press-Kit-1-1

For information on BiondVax in the news, please visit:
www.biondvax.com/128084/BiondVax-in-the-News-1

Forward Looking Statements

Statements included herein that are not historical facts are
"forward-looking statements" within the meaning of applicable securities
laws. These forward-looking statements involve risks and uncertainties,
including those identified within the "Risk Factors" section of the
Company's Shelf Prospectus dated 26 November 2009.

Although management of the Company believes the expectations reflected in
such forward-looking statements are based on reasonable assumptions, the
Company cannot assure investors that these expectations will prove
correct, and the actual results that the Company achieves may differ
materially from any forward-looking statements, due to such risks and
uncertainties.

    For further information, please contact:

    BiondVax Pharmaceuticals Ltd.:
    Dr. Ron Babecoff, President & CEO     Tel: +972-8-930-2529
                                          info@biondvax.com

    Media:
    Nancy Shapira-Aronovic                Tel: +972-3-607-0588
    Public Relations Consultant           Mob: +972-54-486-3888
    Gelbart-Kahana                        nancy@gksmarketing.com

For further information, please contact: BiondVax Pharmaceuticals Ltd.: Dr. Ron Babecoff, President & CEO, Tel: +972-8-930-2529, info at biondvax.com; Media:Nancy Shapira-Aronovic, Public Relations Consultant, Gelbart-Kahan, Tel: +972-3-607-0588, Mob: +972-54-486-3888, nancy at gksmarketing.com

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