BiondVax Reports Positive Interim Safety Results from Second Phase I/II Universal Influenza Vaccine

From: Gelbart Kahana Global Marketing
Published: Mon Mar 15 2010

BiondVax Pharmaceuticals Ltd. (TASE: BNDK), an Israeli biopharmaceutical company at the forefront of the development of a Universal Influenza Vaccine, is pleased to announce that it has successfully completed the clinical phase of its second Phase I/II clinical trial as planned, and that interim results demonstrate that the Company’s Multimeric-001 Universal Influenza Vaccine is safe and well tolerated at all doses tested, both with and without adjuvant.

The Phase I/II clinical trial, the second of two such trials BiondVax is conducting, is a randomized, single-blinded, placebo-controlled study, designed to ascertain the safety and immunogenicity of the Multimeric-001 Universal Flu Vaccine in the elderly, one of the population groups most at-risk for influenza infections. The trial commenced in September 2009, and included a total of 60 participants aged 55-75, who received two injections, either with or without adjuvant, at two different doses and in accordance with the approved clinical trial design.

The initial results show that Multimeric-001 is safe and well tolerated. No severe or serious adverse events were found in any of the participants.

The Company expects to be able to announce final results from this clinical trial, that will provide both immunogenicity results and more detail regarding the safety results, during April 2010.

BiondVax CEO, Dr. Ron Babecoff, notes that "These latest excellent safety results are further evidence of the positive safety profile of our Multimeric-001 vaccine. We are especially pleased to have been able to show the safety of the vaccine in the elderly population, which is one of the most at-risk and vulnerable sectors of the population to flu infections. Following the recent success of the first Phase I/II study in which we showed proof of the safety and immunogenicity of our vaccine in younger participants, these additional safety results represent yet another successful achievement in our path towards the development of the Universal Flu Vaccine."

Dr. Tamar Ben Yedidia, BiondVax’s CSO, notes that, "We are extremely encouraged by the positive Phase I/II safety results showing additional evidence of the excellent safety profile of the Multimeric-001. Furthermore, it allows us considerable flexibility in the design of the upcoming Phase II trials, to potentially investigate the use of even higher doses of the vaccine, without the addition of an adjuvant".

In December 2009, BiondVax announced the successful conclusion of its first Phase I/II trial of the Multimeric-001 Universal Flu Vaccine. In that trial, the vaccine was shown to be safe and well tolerated, and to effectively activate both arms (humoral and cellular) of the human immune system, stimulating immune responses against both Influenza Type A and Influenza Type B strains in participants aged 18-49. BiondVax is well-funded to execute its clinical development program for the Universal Flu Vaccine for 2010 and 2011, having raised $5.5m in December 2009 in a secondary offering on the Tel-Aviv Stock Exchange. In addition, the Company recently announced the signing of a term sheet with Yorkville Advisors for a standby equity facility of $7m, with the possible expansion to $15m. BiondVax is currently considering the establishment of a pilot manufacturing plant for the production of the Multimeric-001 Universal Influenza Vaccine, which will be able to produce clinical grade material suitable for the upcoming Phase II and III clinical trials.

For further information, please contact:

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

Nancy Shapira-Aronovic
Public Relations Consultant
Gelbart-Kahana Tel: +972-3-607-0588
Mob: +972-54-486-3888

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 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®, a blockbuster drug for the treatment of multiple sclerosis. BiondVax 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 Universal Influenza vaccine, in two Phase I/II clinical trials.

BiondVax’s team of 13 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:
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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.

Danny Aronovic
Gelbart Kahana Global Marketing
Ness Ziona, Israel
Tel: +97298995813
Company: Gelbart Kahana Global Marketing
Contact Name: Danny Aronovic
Contact Email:
Contact Phone: 97298995813

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