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BiondVax Announces Positive Phase IIa Results for Universal Flu Vaccine

June 16, 2011

NESS ZIONA, Israel, June 16, 2011 /PRNewswire/ –

BiondVax Pharmaceuticals Ltd. (TASE: BNDX) [http://www.biondvax.com ]
today announced positive results from its first Phase II clinical trial of
the Multimeric-001 Universal Influenza Vaccine. The vaccine was found to be
safe and well tolerated, and induced robust immune responses, successfully
meeting both the primary safety and immunogenicity endpoints, as well as
additional secondary immunogenicity endpoints. It was also found that the
Multimeric-001, when used in conjunction with a commercially available
strain-dependant seasonal influenza vaccine (trivalent inactivated vaccine,
or TIV), enhances the performance of the TIV by increasing the rates of
Hemagglutination Inhibition (HI) seroconversion to influenza strains both
included, and not-included, in the TIV itself.

Dr. Ron Babecoff, BiondVax’s CEO
[http://www.biondvax.com/128084/Executive-Management-1 ], said “We are very
excited with these positive Phase IIa results. We have confirmed, in what is
to our knowledge the first Phase II study of a universal influenza vaccine
ever conducted in the world, that the Multimeric-001 vaccine is not only safe
and immunogenic on its own, but it also has the potential to enhance the
performance of traditional strain-dependant flu vaccines. We are more
convinced than ever that this product will provide real benefit to people
all over the world, bringing the ultimate goal of a universal influenza
vaccine closer than ever before.”

This Phase IIa trial was a randomized, double-blind, placebo-controlled
study in 200 healthy volunteers conducted at two clinical research centers
in Israel – the Hadassah University Hospital in Jerusalem and the Tel Aviv
Sourasky Medical Center.

The Multimeric-001 vaccine was safe and well tolerated, thus meeting the
first primary endpoint of the study. No vaccine-related severe adverse
events were found in any of the participants, nor were there any significant
differences between treatment and control groups. These findings further
reinforce the positive safety profile of the Multimeric-001 vaccine reported
in the Company’s Phase I/II trials.

The vaccine also induced both humoral (antibody) and cell-mediated
immune responses, further confirming previous results from the Phase I/II
clinical trials. Participants who received two doses of the Multimeric-001
vaccine, in an adjuvanted 500mcg formulation, showed a statistically
significant increase in the level of IgG antibodies against the
Multimeric-001 vaccine, thus meeting the second primary endpoint of the
study. It was also found that the Multimeric-001 vaccine caused a
statistically significant elevation in the secretion of Interferon-gamma (a
known anti-viral agent) to the Multimeric-001, meeting one of the secondary
endpoints.

In addition, the Multimeric-001 vaccine, when administered once
concomitantly with a 50% dose of a seasonal TIV, also induced higher rates
of hemagglutination inhibition (HI) antibody responses (a surrogate marker
of protection against influenza infection which is accepted by the
regulatory authorities), when compared with the TIV alone. These results
confirm the findings from the Phase I/II trial in older adults completed in
April 2010, and again show that the combination of the Multimeric-001
vaccine with the TIV has the potential to increase the number of people who
reach the HI seroconversion levels required by the US and European
regulatory authorities for licensure of influenza vaccines, than when
compared with the TIV alone. Importantly, this increase in HI seroconversion
rates has been observed not only against strains that were included in the
TIV, but also against additional Type A (H1N1 and H3N2) and Type B influenza
strains that were not included in the TIV.

These results suggest that the Multimeric-001 has the potential, when
administered in advance of future seasonal or pandemic influenza outbreaks,
to raise the general level of preparedness of the population and thereby
significantly improve the protection and broaden the cross-strain coverage
offered by the strain-dependant influenza vaccines.

In light of the successful conclusion of this Phase IIa clinical trial,
BiondVax is preparing to conduct the next Phase II trial, in the elderly -
the population group most at risk for influenza infections, and for whom
current influenza vaccines are least effective. It is expected that this
trial will be conducted in two centers in Israel, in around 110 male and
female participants aged 65 and over. This trial is expected to commence in
the fourth quarter of 2011 and to be concluded in the first quarter of 2012.

Dr. Tamar Ben Yedidia, BiondVax’s Chief Scientific Officer
[http://www.biondvax.com/128084/Executive-Management-1 ], notes that, “the
results of this Phase IIa trial are most gratifying. We have now shown, in
three clinical trials in over 320 participants, that the Multimeric-001
vaccine is safe and effectively activates the immune system, both on its own
as well as in conjunction with the traditional flu vaccines. This gives us
much confidence as we proceed with further Phase II and Phase III studies.”

Dr. Ben Yedidia will be presenting the results of this Phase IIa
clinical trial at the BIO International Convention in Washington DC, USA, on
29 June 2011, in a presentation entitled “Clinical Progress Towards the
Development of a Universal Influenza Vaccine”. [http://convention.bio.org ]

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 innovative 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 a Phase IIa clinical trial, as well
as two Phase I/II trials, in which the Multimeric-001 Universal Flu Vaccine
was shown to be safe and immunogenic. The Company is now preparing for
further Phase II clinical trials to be conducted in 2011 and 2012.

For further information on BiondVax, please visit

http://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@shapiramarketing.com

SOURCE Biondvax Pharmaceuticals Ltd


Source: newswire



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