Second successful Phase I/II Clinical Trial for BiondVax's Universal Flu Vaccine

BiondVax Pharmaceuticals’ Multimeric-001 Universal Flu Vaccine was found to be safe and to activate both arms of the human immune system in a trial of 60 older adult participants

RECHOVOT, Israel | APRIL 28, 2010 | BiondVax Pharmaceuticals Ltd. (TASE:BNDK), an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, announced the successful conclusion of the Company’s second Phase I/II clinical trial of the Multimeric-001 Universal Influenza Vaccine. This second Phase I/II trial was a randomized, single-blind, placebo-controlled, escalating double-dose safety study conducted at the Sourasky Medical Center in Tel Aviv, Israel, in which a total of 60 participants, males and females aged 55-75, received two intramuscular injections containing the vaccine, either with or without adjuvant, and at two different dose levels. This was then followed by an administration of a commercially available seasonal influenza vaccine.

* 60 people, males and females, aged 55-75, participated in the trial
* Safety and immunogenicity shown in the “at-risk” older adult population group
* BiondVax's CEO Dr. Ron Babecoff: “We are very excited by the positive results we have achieved in this older population group, which gives us further confidence for the upcoming Phase II trials, scheduled for later this year.”

This trial is the second of two Phase I/II clinical trials of the Multimeric-001 Universal Flu Vaccine that have been conducted by BiondVax. In the first trial, which was successfully concluded in December 2009, with 63 participants aged 18-49, the vaccine was shown to be safe and to effectively activate both humoral (antibody) and cellular arms of the human immune system.

In this second clinical trial, as in the first, the results show that BiondVax’s Multimeric-001 Universal Flu Vaccine is safe and well tolerated at all doses tested, both with and without adjuvant.

In addition, despite the fact that the immune systems of the older group participating in this second trial are naturally weaker than those of the younger group that participated in the first trial, it was again found that the Multimeric-001 Universal Flu Vaccine successfully activated the two arms of the human immune system – the humoral (antibody) arm and the cellular arm.

From a humoral immunity perspective, all participants who received the vaccine showed a statistically significant increase in the level of antibodies against the Multimeric-001 Universal Flu Vaccine.

From a cellular immunity perspective, it was again found that the Multimeric-001 Universal Flu Vaccine caused a statistically significant elevation in the secretion of Interferon Gamma and Interleukin-2, substances that have an anti-viral effect. This cellular response distinguishes BiondVax’s Multimeric-001 Universal Flu Vaccine from existing seasonal flu vaccines, which are characterized mainly by their ability to stimulate only a humoral (antibody) response.

As was found in the first Phase I/II trial, the highest immunogenicity was observed when using the highest dose (500mcg), adjuvanted formulation, of the Multimeric-001 Universal Flu Vaccine.

In light of the successful conclusion of the two Phase I/II clinical trials, BiondVax is preparing, as planned, to enter into Phase II clinical trials for the Multimeric-001 vaccine. This trial is expected to be conducted in two centers in Israel, in around 160 participants 18-49 years old. This trial is expected to commence in the second half of 2010. BiondVax will be financing this trial itself, with funding secured in the successful follow-on offering conducted by the Company on the Tel Aviv Stock Exchange in December 2009.

Ron+Babecoff%2C+BiondVax+CEO&index=2&md5=a0c285dfd698e7fe2b4dd6eb43fc263e">Dr. Ron Babecoff, BiondVax CEO, notes that “We are very proud to announce the successful conclusion of our Phase I/II clinical trial program for the Multimeric-001 Universal Flu Vaccine. In two studies, in both younger and older adult population groups, we have shown that our vaccine is safe and well tolerated, and successfully activates both arms of the immune system. We are especially gratified by the positive results found in the older population group, which exceeded our expectations, as this is a group in which the immune system response is more difficult to stimulate than in younger adults. We are confident that we now have a strong clinical candidate with which to advance to Phase II trials.”

Dr. Tamar Ben Yedidia, BiondVax’s Chief Scientific Officer, notes that, “the success of this trial in the older population group is extremely important. We have shown that our vaccine is safe for use and effectively activates the immune system, even in the older population group that has a naturally weaker immune response, and hence is one of the groups most at risk from influenza infections.”

Dr. Ben Yedidia will be presenting the results of BiondVax’s Phase I/II clinical trial program at the BIO International Convention in Chicago, USA, on 5 May 2010, in a presentation entitled “The Quest for a Universal Influenza Vaccine”.

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 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 recently successfully concluded a second Phase I/II clinical trial for its lead product, the Multimeric-001 vaccine. The vaccine has been shown to be safe and immunogenic in both Phase I/II clinical trials.

For further information on BiondVax, please visit the Company’s website:

SPURCE: BiondVax

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