NESS ZIONA, Israel, November 22, 2016 /PRNewswire/ --
At the same time, highly pathogenic H5N8 Avian Influenza is spreading rapidly throughout Europe and through multiple avian species. As predicted in September by the OIE[2], H5N8 is being transmitted along wild bird migratory routes originating in Russia. In the past month alone new outbreaks have been confirmed in Germany, Hungary, Poland, Austria, Croatia, Denmark, Iran, Israel, India, Switzerland, and the Netherlands.
While H5N6 has caused severe illness in humans[3], there is not yet any evidence of human-to-human transmission. Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientist explains, "Despite the admirable efforts of the world's leading experts, H5 bird flu strains continue to emerge, evolve, and spread. The concern of all experts is the reassortment of a new H5 strain capable of human-to-human transmission. This could lead to a new pandemic against which currently available vaccines are ineffective. Fortunately, BiondVax's vaccine is designed to defend against these new potential pandemic viruses."
BiondVax's universal flu vaccine candidate, M-001, has shown positive results in five human clinical trials to date. As previously reported by the Company, BiondVax has also entered strategic collaborations to conduct clinical trials in the USA and Europe, including the upcoming American NIH-sponsored Phase 2 trial, testing M-001 as a primer against H7 pandemic. Results from the Phase 2b EU-sponsored UNISEC consortium trial, testing M-001 as a primer against pandemic H5N1, are expected in the coming months. Ben-Yedidia continued, "Our vaccine candidate has induced immune responses against multiple strains including H5 and H7[4],[5]. Our investigations also confirm that M-001's epitopes are a good match for H5N6 and H5N8."
BiondVax offers Proactive Preparedness for Future Pandemics: When the 2009 H1N1 Swine Flu Pandemic occurred, it took over six months until the specific pandemic vaccine was produced and administered. There were over 60 million swine flu cases and 274,000 hospitalizations in the USA[6], and an estimated 284,000 deaths worldwide[7], while vaccine manufacturers recognized $6.4 billion in additional revenue[8]. Since M-001 is designed as a common denominator vaccine against existing and future seasonal and pandemic flu strains, it can be stockpiled, thereby dramatically reducing response lead time to any new pandemic.
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1. http://www.promedmail.org/post/4641187
2. http://www.promedmail.org/post/20160920.4501532
3. http://www.who.int/csr/don/08-june-2016-ah5n6-china/en/
4. http://www.globes.co.il/en/article-1000911070 "BiondVax universal flu vaccine matches all pandemic strains"
5. http://www.biondvax.com/2012/12/biondvaxs-universal-influenza-vaccine-m-001-significantly-enhances-the-efficacy-of-the-human-pandemic-h5n1-bird-flu-vaccine/ [http://www.biondvax.com/2012/12/biondvaxs-universal-influenza-vaccine-m-001-significantly-enhances-the-efficacy-of-the-human-pandemic-h5n1-bird-flu-vaccine ]
6. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm
7. http://www.cidrap.umn.edu/news-perspective/2012/06/cdc-estimate-global-h1n1-pandemic-deaths-284000
8. http://www.reports-research.com/news/datamonitor-vaccine-market-overview-2010.html
About BiondVax Pharmaceuticals Ltd
BiondVax (NASDAQ: BVXV) (TASE: BVXV) is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the timing and results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization, ultimate market acceptance of the vaccine candidate, assuming approval and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
For further information, please contact: Joshua E Phillipson Business Development +972-8-930-2529 x5105 [email protected] Kenny Green Investor Relations +1 646 201 9246 [email protected]
SOURCE BiondVax Pharmaceuticals Ltd.
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The first cases of highly pathogenic H5N6 Avian Influenza ("Bird Flu") were confirmed last week in South Korea[1]. Over 62,000 birds have been culled in an effort to prevent the spread. H5N6 first emerged in 2014 and has since been found in China, Hong Kong, Laos, and Vietnam.
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At the same time, highly pathogenic H5N8 Avian Influenza is spreading rapidly throughout Europe and through multiple avian species. As predicted in September by the OIE[2], H5N8 is being transmitted along wild bird migratory routes originating in Russia. In the past month alone new outbreaks have been confirmed in Germany, Hungary, Poland, Austria, Croatia, Denmark, Iran, Israel, India, Switzerland, and the Netherlands.
While H5N6 has caused severe illness in humans[3], there is not yet any evidence of human-to-human transmission. Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientist explains, "Despite the admirable efforts of the world's leading experts, H5 bird flu strains continue to emerge, evolve, and spread. The concern of all experts is the reassortment of a new H5 strain capable of human-to-human transmission. This could lead to a new pandemic against which currently available vaccines are ineffective. Fortunately, BiondVax's vaccine is designed to defend against these new potential pandemic viruses."
BiondVax's universal flu vaccine candidate, M-001, has shown positive results in five human clinical trials to date. As previously reported by the Company, BiondVax has also entered strategic collaborations to conduct clinical trials in the USA and Europe, including the upcoming American NIH-sponsored Phase 2 trial, testing M-001 as a primer against H7 pandemic. Results from the Phase 2b EU-sponsored UNISEC consortium trial, testing M-001 as a primer against pandemic H5N1, are expected in the coming months. Ben-Yedidia continued, "Our vaccine candidate has induced immune responses against multiple strains including H5 and H7[4],[5]. Our investigations also confirm that M-001's epitopes are a good match for H5N6 and H5N8."
BiondVax offers Proactive Preparedness for Future Pandemics: When the 2009 H1N1 Swine Flu Pandemic occurred, it took over six months until the specific pandemic vaccine was produced and administered. There were over 60 million swine flu cases and 274,000 hospitalizations in the USA[6], and an estimated 284,000 deaths worldwide[7], while vaccine manufacturers recognized $6.4 billion in additional revenue[8]. Since M-001 is designed as a common denominator vaccine against existing and future seasonal and pandemic flu strains, it can be stockpiled, thereby dramatically reducing response lead time to any new pandemic.
--------------------------------------------------
1. http://www.promedmail.org/post/4641187
2. http://www.promedmail.org/post/20160920.4501532
3. http://www.who.int/csr/don/08-june-2016-ah5n6-china/en/
4. http://www.globes.co.il/en/article-1000911070 "BiondVax universal flu vaccine matches all pandemic strains"
5. http://www.biondvax.com/2012/12/biondvaxs-universal-influenza-vaccine-m-001-significantly-enhances-the-efficacy-of-the-human-pandemic-h5n1-bird-flu-vaccine/ [http://www.biondvax.com/2012/12/biondvaxs-universal-influenza-vaccine-m-001-significantly-enhances-the-efficacy-of-the-human-pandemic-h5n1-bird-flu-vaccine ]
6. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm
7. http://www.cidrap.umn.edu/news-perspective/2012/06/cdc-estimate-global-h1n1-pandemic-deaths-284000
8. http://www.reports-research.com/news/datamonitor-vaccine-market-overview-2010.html
About BiondVax Pharmaceuticals Ltd
BiondVax (NASDAQ: BVXV) (TASE: BVXV) is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the timing and results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization, ultimate market acceptance of the vaccine candidate, assuming approval and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
For further information, please contact: Joshua E Phillipson Business Development +972-8-930-2529 x5105 [email protected] Kenny Green Investor Relations +1 646 201 9246 [email protected]
SOURCE BiondVax Pharmaceuticals Ltd.
