Navigation Links
BiondVax Phase 2b Trial Preliminary Safety Results: The Universal Flu Vaccine Candidate is Safe and Well Tolerated
Date:11/29/2016

NESS ZIONA, Israel, November 29, 2016 /PRNewswire/ --

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary safety results from its European Phase 2b clinical trial of M-001, its universal flu vaccine candidate.

The trial is designed to compare safety and immunogenicity of M-001 between (1) a control group receiving saline as a placebo and then the standard H5N1 avian pandemic vaccine, and (2) an experimental group receiving BiondVax's M-001 as a primer prior to receiving the same H5N1 pandemic vaccine. As the data is still blinded, the distribution of adverse events between the total of 219 participants who completed the study in both the control and experimental groups is unknown. Only 3 moderate adverse events were considered to be possibly or probably related to the treatment and no related severe adverse events were reported.

Professor Shai Ashkenazi, recently appointed to BiondVax's Scientific Advisory Board, who has guided multiple vaccines through clinical and regulatory approval phases to market, commented that, "M-001 continues to display a remarkable safety profile. It is at least as safe, if not safer, than the current flu vaccines. As we can see in the entire study population, both control and experimental groups, the total number of adverse events is very low and mild."

The research leading to these preliminary results has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012. Conducted in collaboration with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used ahead of a pandemic influenza vaccine. BiondVax's European consortium partners are continuing humoral and cellular immune response analysis, with results expected in the coming months.

About BiondVax Pharmaceuticals Ltd 

BiondVax 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, results in Phase 2b clinical trials may not be indicative of results from later stage or larger scale clinical 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
j.phillipson@biondvax.com

Kenny Green
Investor Relations
+1-646-201-9246
kenny@biondvax.com


'/>"/>
SOURCE BiondVax Pharmaceuticals Ltd.
Copyright©2016 PR Newswire.
All rights reserved


Related medicine technology :

1. BiondVax Pharmaceuticals Ltd. Announces a Closing of Over-Allotment Option
2. BiondVax Presents BVX-006 Preliminary Phase II Results: the Universal Flu Vaccine at Higher Doses is Safe and Improves Immunogenicity in Older Adults
3. Independent Results Show that BiondVaxs Universal Flu Vaccine Administered in a Trial 3 Years ago Improves Immunogenicity Against Current Flu H3N2 Epidemic
4. BiondVax to Present on September 10 at the Rodman & Renshaw Global Investment Conference
5. BiondVax to Present on October 8 at the Aegis Growth Conference
6. Biondvaxs Universal Flu Vaccine Receives Additional US Patent
7. BiondVax Receives Additional Grant Approval
8. BiondVax CEO to Present at Roth Conference on Wednesday, March 16
9. BiondVax to Present Tomorrow at Joseph Gunner Pioneers 2016 Conference
10. BiondVax Announces Third Quarter 2016 Financial Results and Update
11. Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)... NuvoAir (formerly called Pond Healthcare Innovation), the company commercializing ... Pharma AG to distribute NuvoAir,s spirometry technology to physicians worldwide. ... platform and Novartis, commitment to address the unmet medical needs ... ... "We are ...
(Date:9/6/2017)... TORONTO , Sept. 6, 2017 /PRNewswire/ ... new knowledge and skills while treating their ... for hands-on experience without involving patients. Simulation ... skills. Clinicians can carry out procedures, refine ... at risk. Integration of new technology, such ...
(Date:9/5/2017)... 5, 2017 Sapheneia and Scannerside received FDA ... DoseCheck is a third-party Vendor neutral CT product that ... allows compliance with current MITA standards. ... DoseCheck solution is specifically designed to provide CT operators, ... radiation doses over a predefined threshold. Scannerside Dose Check ...
Breaking Medicine Technology:
(Date:9/25/2017)... ... 2017 , ... The Asset Tracking and Temperature monitoring system works in conjunction ... the bar code of the product and lot ID then scanning the HPP basket ... are automatically generated and exception alerts sent out to designated individuals. , "In recognizing ...
(Date:9/25/2017)... ... September 25, 2017 , ... Leonard Bley, MD ... next generation for LASIK in Manhattan with Contoura Vision, the latest WaveLight® topographic-guided ... systems available in the United States to correct nearsightedness and nearsightedness with astigmatism. ...
(Date:9/25/2017)... ... , ... “Renew Refresh Restore Reward”: is a story of struggle and how ... published author, Deborah Freeman, cofounded the Free Spirit Bible Church and currently serves as ... my sister-in-law invited us to come over before the baby had to go back ...
(Date:9/25/2017)... (PRWEB) , ... September 25, 2017 , ... “The Majestic ... unicorns—during the great flood. “The Majestic Unicorn” is the creation of published author, Dayna ... or small, came from far and wide to march aboard the cypress ark-vessel. Male ...
(Date:9/25/2017)... Los Angeles, CA (PRWEB) , ... September 25, 2017 , ... ... opening of a full-time office in downtown Los Angeles, to service existing clients in ... the surrounding areas. , “We are seeing an ever-increasing amount of business demand west ...
Breaking Medicine News(10 mins):