BiondVax Reports Positive Interim Safety Results
Mar 09, 2010“ BiondVax Reports Positive Interim Safety Results from Second Phase I/II Universal Influenza Vaccine Trial BiondVax’s Multimeric-001 Universal Flu Vaccine Shown to be Safe and Well Tolerated in trial of 60 elderly participants ”
Share on
Email Friend Contact Author
Attachment
Share on
Email Friend Contact Author
(iHealthWire.Org) – Ness Ziona, Israel – 8 March 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.
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: www.biondvax.com
For information on BiondVax in the news Please visit: http://www.biondvax.com/128084/BiondVax-in-the-News-1
For an online press kit: http://www.biondvax.com/128084/Press-Kit-1-1
Submitted by Danny Aronovic, Gelbart Kahana email: danny@gksmarketing.com
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.
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.
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: www.biondvax.com
For information on BiondVax in the news Please visit: http://www.biondvax.com/128084/BiondVax-in-the-News-1
For an online press kit: http://www.biondvax.com/128084/Press-Kit-1-1
Submitted by Danny Aronovic, Gelbart Kahana email: danny@gksmarketing.com
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.
# # #
| Released By | Dan Aronovic |
Disclaimer: The opinions presented above are authors only and not iHealthWire.Org's. Issuers of the press releases are solely responsible for the content of their press releases. iHealthWire.Org does not endorse the above contents in any way and can't be held liable for the contents of the press releases. Report Abuse
|
Most Popular (Last 30 days) Effective Social Media Marketing Strategies for Pharmaceutical Market through Bharatbook Third of Young Women Shun Breast Feeding for Vanity E-Cigarettes or Snus May Cost, Not Save, Lives - Study Smokeless Tobacco Causes Heart Disease and Death Healthy Diet Weight Loss Burn Fat Diet and Weight Loss Tips - Eating Diet Plan Nature's Agave Selected by Kirstie Alley's New Organic Liaison Weight-loss Program! 6% Think Transgender Operations Should Be ‘illegal’ PBS TV Newest Fitness Series DVD's Now Available to Libraries Best Way To Lose Weight Fast : Burn Fat Belly With This FREE Gift |