Navigation Links
Successful Phase I/II Clinical Trial for BiondVax Pharmaceuticals' Universal Flu Vaccine
Date:12/7/2009

RECHOVOT, Israel, Dec. 7 /PRNewswire/ --

  • 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".



For further information, please contact:

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

Media:
Nancy Shapira-Aronovic                    Tel: +972-3-607-0588
Public Relations Consultant               Mob: +972-54-486-3888
Gelbart-Kahana                            nancy@gksmarketing.com



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, 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 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. The Company 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 vaccine, in two Phase I/II clinical trials.

BiondVax's team 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: www.biondvax.com

For logos, pictures and other company information please visit:

http://www.biondvax.com/128084/Press-Kit-1-1

For information on BiondVax in the news, please visit:

http://www.biondvax.com/128084/BiondVax-in-the-News-1

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.

SOURCE BiondVax Pharmaceuticals Ltd.


'/>"/>
SOURCE BiondVax Pharmaceuticals Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Dermagen Reports Successful Phase I/IIa Clinical Trial for Atopic Dermatitis
2. Phonak Successfully Hosts Hearing Care for Adults 2009 Conference
3. Anesiva Announces Prospective Board Members To Be Appointed Upon Successful Completion of Proposed Merger
4. L.A. Zoo Announces Successful Cancer Treatment of Rhinoceros With Electronic Brachytherapy
5. London Genetics Focuses on Partnering Following Successful Pharmacogenetics Conference
6. Tamaulipas Comparative Wound Healing Test Treatment Successfully Concluded
7. Reportlinker Adds Driving Successful Pharma Brands: Case Studies of Real Product Launches
8. Educating the Marketplace to Support Successful Oncology Product Launches
9. Transave Completes Successful Phase II Clinical Program for ARIKACE in the Treatment of Pseudomonas Lung Infections
10. Dartmouth Medical School Faculty Member and Anesthesiologist Invents Revolutionary Catheter System Designed to Increase Rate of Successful IV Insertions by 75 Percent
11. DBMS Consulting Successfully Completes Roll out of Oracle Health Sciences Applications (OHSA) Suite for SIRO Clinpharm
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... Pharmaceutical giant Johnson & Johnson ... woman who says its talc-based powder products caused ovarian ... $5 million in compensatory damages and $50 million ... ) , This is the second ... February, the same court awarded $72 million to the ...
(Date:5/3/2016)... 2016  Forté Elements, LLC (Forté) is excited to announce the launch of its ... nutritional needs of recovery for a variety of clinical conditions. Founded in 2013, Forté ... http://photos.prnewswire.com/prnh/20160502/362548 Logo -  http://photos.prnewswire.com/prnh/20160502/362547LOGO ... ... ...
(Date:5/2/2016)... Leading Economies with Fastest Real GDP Annual Percentage Change, 2015  ... 7.8 India 7.3, , Source: IMF and TechSci Research   ... Brazil , Russia , India ... , registered the fastest GDP growth during the first decade of the 21 ... in Brazil and Russia , along ...
Breaking Medicine Technology:
(Date:5/3/2016)... ... May 03, 2016 , ... ... director Joe Ferrazano to serve in the newly created position of executive vice ... the agency’s creative efforts in the Chicago and LA offices. He reports to ...
(Date:5/3/2016)... ... May 03, 2016 , ... ... pharmacies, will be represented at the 2016 Asembia Specialty Pharmacy Summit held May ... is the largest U.S. health care conference for the specialty pharmacy industry, with ...
(Date:5/3/2016)... Ind. (PRWEB) , ... May 03, 2016 , ... ... that it has been selected by Tidelands Health, a three hospital system in ... to be constantly on the lookout for technology that enhances communication, drives workflow ...
(Date:5/3/2016)... ... 2016 , ... Nationally recognized personal injury law firm Monge & Associates is honoring ... anyone who wants one for their Mother or any other mother figure. , According to ... Mothers.” Monge goes on to say, “we are choosing to do this by giving ...
(Date:5/3/2016)... ... 03, 2016 , ... Ogawa World USA introduced the first of its kind ... exclusive Smart Application. The Smart 3D combines the best in technological advancement, design, and ... profile and specialized massage program, each user has a tailored experience unparalleled by any ...
Breaking Medicine News(10 mins):