Navigation Links
BiondVax Presents BVX-006 Preliminary Phase II Results: the Universal Flu Vaccine at Higher Doses is Safe and Improves Immunogenicity in Older Adults

NESS ZIONA, Israel, June 29, 2015 /PRNewswire/ --

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary results from its BVX-006 Phase II clinical trial of M-001, BiondVax's candidate for a universal influenza vaccine. In this trial, M-001 was injected intramuscularly to volunteers between the ages of 50 to 65, followed by an administration of the 2014/15 season trivalent influenza vaccine (TIV) 3 weeks later. M-001 was found to be safe and well tolerated and induced humoral immune responses, successfully meeting the primary safety and secondary immunogenicity endpoints.

M-001 in a 1mg dose, primed for immune responses in a manner consistent with previous data in this age group, confirming BiondVax's approach to the development of a universal influenza vaccine. Furthermore, as demonstrated in previous tests, a broadening of the immune response to elicit responses against strains not included in the standard influenza vaccine was detected.

M-001 also elevated the immune response to other strains which were not included in the current influenza seasonal vaccine including against the drifted H3N2 strain of influenza that has caused this year's epidemic in the United States. These results support BiondVax's claim that M-001 provides a broadened and improved coverage against multiple influenza type A and B virus strains.

In addition, the excellent safety profile demonstrated for the 1 mg dose of M-001 will enable BiondVax to safely administer this dose in upcoming trials (such as BVX-007 in Europe). The increased dose is expected to further improve the immune responses against multiple influenza strains when given as a primer or as a standalone product without an adjuvant. Furthermore, the 1mg dose can be particularly beneficial to a population with weakened immunity, such as the elderly.

Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientific Officer, noted that, "We are very pleased with the results of this trial, which provide us with additional supporting data that our M-001 increases the immune response against multiple flu strains. The results indicating that the 1mg dosage level was well tolerated is very important and these positive results support our continued research and ongoing trials."

Added Dr. Ron Babecoff, BiondVax's President and CEO, "We are very happy with these results, as they demonstrate the importance and value to society of developing M-001. This successful trial brings us one step further towards the phase 3 clinical trial."

About BiondVax Pharmaceuticals Ltd 

BiondVax is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal and pandemic flu strains.

BiondVax's technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect.

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, uncertainty of clinical preliminary trial results or regulatory approvals or clearances, risks inherent in the development and commercialization of potential products, dependence upon collaborators, adequate resources to undertake and complete the Phase II clinical trials and the success thereof, the market acceptance of our flu vaccine as a broad-coverage solution and adequacy of capital resources for product development and commercialization. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.

For further information, please contact:
Company Contact
Dr Limor Chen, Director of  BD

Investor Relations Contact
GK Investor Relations
Kenny Green, Partner

SOURCE Biondvax Pharmaceuticals Ltd
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. BiondVax Pharmaceuticals Ltd. Announces a Closing of Over-Allotment Option
2. CSL Behring Presents rIX-FP for Hemophilia B Phase III Data Evaluating Efficacy, Safety and Improved Dosing at ISTH 2015
3. Amgen Presents Open-Label Extension Data From Ongoing Phase 2 Study Of AMG 334 In The Prevention Of Episodic Migraine
4. Developing Human Organs: 3D Bioprinting Presents the Healthcare Sector with Revolutionary Opportunities
5. Takeda Presents Additional Data from Alogliptins EXAMINE Cardiovascular Safety Outcomes Trial at the American Diabetes Associations 75th Scientific Sessions
6. DelMar Pharmaceuticals Presents Updated Phase I/II Clinical Data on VAL-083 in Refractory Glioblastoma Multiforme (GBM) at ASCO
7. AbbVie Presents Phase 2 Results from Study of Investigational Medicine Veliparib in Patients with Non-Small Cell Lung Cancer at the American Society of Clinical Oncology Annual Meeting
8. AbbVie Presents Results from Phase 1 Studies of Investigational Compound Venetoclax in Patients with Multiple Myeloma at the American Society of Clinical Oncology Annual Meeting
9. Caris Life Sciences Presents New Tumor Profiling Research Providing Insights into the Clinical Benefit of Targeted Therapies for Colorectal Cancer Treatment-Resistant Subgroups
10. DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme
11. Amgen Presents Pooled Phase 3 AMG 416 Data For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease
Post Your Comments:
(Date:6/16/2019)... ... June 15, 2019 , ... ... clinic offering state-of-the-art treatment with cutting-edge technology, has opened. , The clinic ... game-changing healing capabilities of regenerative medicine. , “Using the remarkable cutting-edge technology ...
(Date:6/14/2019)... MORRISTOWN, N.J. (PRWEB) , ... ... ... LLC has launched SIMPLY, a forecasting and analytics platform that helps Life ... SIMPLY addresses critical problems for Life Sciences business leaders: accurate, automated forecasting ...
(Date:6/13/2019)... (PRWEB) , ... June 13, 2019 , ... ... as a Prime awardee of the Network of Quality Improvement and Innovation Contractor. ... five years. As a Prime NQIIC awardee partnering with other Quality Improvement ...
Breaking Medicine Technology:
(Date:6/16/2019)... ... 14, 2019 , ... GTB Technologies, the global leader ... the coveted “2019 Best DLP Solution Provider” Award from Acquisition International and will ... additions to its Data Security Portfolio (DSP) during the Gartner Security and Risk ...
(Date:6/16/2019)... , ... June 16, 2019 , ... ... MMJ International Holdings executives focusing on scientific research for the advancement of medical marijuana-based ... on CNBC. Check your local listings for more information. , With two investigational new ...
(Date:6/14/2019)... ... ... This past Saturday, volunteers from Bright Now! Dental delivered smiles ... Day of Giving, where members of underserved communities were able to receive pro bono ... the Smiles for Everyone Foundation. Some of these organizations include Stella ...
(Date:6/13/2019)... , ... June 13, 2019 , ... Women’s Excellence in Obstetrics and Gynecology specializes in ... some that may be difficult to diagnosis. Women’s Excellence handles routine and complicated pelvic ... , Endometriosis , Heavy periods , Adhesions (scar tissue) ...
(Date:6/13/2019)... ... June 13, 2019 , ... ... their partnership with cannabis delivery company, Driven Deliveries, Inc., the only publicly traded ... covers 93% of the population of California with overnight cannabis delivery to major ...
Breaking Medicine News(10 mins):