Phase I/II clinical trial of Multimeric-001 Universal Flu Vaccine successful

Dec 7 2009

• 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. (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, 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, 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, on 8 December 2009, in a presentation entitled "Delivering an Epitope-based Approach to Universal Influenza Vaccine Development".