BiondVax Begins Phase IIa Study for Universal Flu Vaccine

By Biondvax Pharmaceuticals Ltd, PRNE
Sunday, October 10, 2010

NESS ZIONA, Israel, October 11, 2010 - BiondVax Pharmaceuticals Ltd. (TASE: BNDX) (www.biondvax.com/), an
Israeli biopharmaceutical company at the forefront of global efforts towards
the development of a Universal Influenza Vaccine, today announced that it has
begun to immunize subjects in a Phase IIa clinical trial of the
Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the
safety and immunogenicity of the Multimeric-001 vaccine. The vaccine is
comprised of a unique, proprietary combination of conserved epitopes from
influenza virus proteins, designed to stimulate both humoral (
antibody-mediated) and cell-mediated immunity against both Type A and Type B
influenza strains, and is thereby intended to provide protection against all
seasonal and pandemic flu strains.

The Phase IIa study is a randomized, double-blind, placebo-controlled,
multi-center, safety and immunogenicity study in 200 healthy volunteers. The
study is being conducted at two clinical research centers in Israel, the
Hadassah Clinical Research Center at Hadassah University Hospital in
Jerusalem ("Hadassah") and the Tel Aviv Sourasky Medical Center ("Ichilov").
The principal investigators conducting the clinical trial are Prof. Yoseph
Caraco
, Director of the Clinical Research Center at Hadassah and Dr. Jacob
Atsmon
, Director of the Clinical Research Center at Ichilov.

Dr. Ron Babecoff, BiondVax's President and CEO, said, "The commencement
of this Phase IIa study is a major milestone in the clinical development of
the Multimeric-001 universal influenza vaccine. After the excellent results
we achieved in our two previous Phase I/II trials, in which the
Multimeric-001 vaccine was shown to be safe and immunogenic in both younger
and older adults, we are excited to be embarking on this new important phase
in the development of the universal influenza vaccine."

In the study, a total of 200 subjects, both male and female, 18-49 years
old, will be divided into six groups, enabling the assessment of the safety
and immunogenicity of the Multimeric-001 firstly as a standalone vaccine,
secondly as a primer for a subsequent partial dose of a commercially
available trivalent inactivated vaccine (TIV), and lastly when the
Multimeric-001 vaccine is co-administered together with a TIV.

Participants in the first group will receive two 500 microgram
doses of an adjuvanted formulation of the Multimeric-001 vaccine (the
formulation that performed best in the previous Phase I/II trials), 21 days
apart. These participants will then receive a subsequent partial (15%) dose
of a TIV, 60 days after their second immunization. Participants in this
treatment group will be compared against two control groups: one group that
will receive two administrations of placebo 21 days apart, also followed 60
days later by a partial (15%) dose of TIV, and another group that will only
receive two administrations of adjuvanted placebo, 21 days apart.

Participants in the fourth and fifth groups will receive a single 500
microgram dose of the adjuvanted formulation of the Multimeric-001 vaccine,
co-administered with either a 15% or 50% dose of the TIV, respectively. These
groups will be compared against a control group that will receive a placebo
formulation co-administered with the higher of the two TIV doses.

The primary objectives of the Phase IIa study are to assess safety and
immunogenicity, as measured by the level of IgG antibodies to the
Multimeric-001 vaccine. The secondary objectives of the study are to measure
additional antibody and cellular immune responses, in particular
neutralization by complement, Hemagglutination inhibition (HI) responses (a
measure of protection) against various strains of influenza, as well as
proliferation of Interleukin-2 (IL-2) and Interferon-gamma cytokines. The
company expects to report study results by mid-2011.

About BiondVax Pharmaceuticals Ltd.

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

BiondVax's proprietary technology utilizes a unique, proprietary
combination of conserved epitopes from influenza virus proteins to activate
the immune system for a cross-protecting and long-lasting effect.

BiondVax has successfully concluded two Phase I/II trials in which the
Multimeric-001 Universal Flu Vaccine was shown to be safe and immunogenic.
The Company is now conducting a Phase IIa study, expected to be completed by
mid-2011.

For further information on BiondVax, please visit www.biondvax.com

For further information, please contact: Danny Aronovic,
Tel: +972-9-899-5813. Public Relations Consultant: Mob: +972-50-799-1121.
shapira marketing, danny@gksmarketing.com

For further information, please contact: Danny Aronovic, Tel: +972-9-899-5813. Public Relations Consultant: Mob: +972-50-799-1121. shapira marketing, danny at gksmarketing.com

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