All 224 participants successfully recruited in EU-sponsored trial
NESS ZIONA, ISRAEL, March 28, 2016 –
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced today that enrolment of 224 participants in a Phase 2b clinical trial of M-001, its universal flu vaccine candidate, is complete. The trial, conducted in collaboration with the EU-sponsored UNISEC consortium, is designed to evaluate the safety and immunogenicity of M-001 when used ahead of an avian influenza vaccine. Among other goals the study aims to show the dose sparing potential of M-001 when given prior to avian vaccine, a highly desirable feature in a pandemic scenario, when existing stockpiles of vaccine may be insufficient.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist, explained, “This important milestone, along with the NIH-sponsored Phase 2 trial in the USA, keeps BiondVax on track to be Phase 3 ready by 2017/18. We are excited to be one step closer to bringing our multi-strain and multi-season vaccine against seasonal and pandemic flu to the market.”
Prof. Dr. Eelko Hak, UNISEC clinical trial program work package leader, commented, “This important clinical trial is a major contribution to the mission of the European UNISEC consortium to learn more about the potential of these promising broadly reactive new vaccines.”
Results from this trial are expected late 2016 or early 2017.
About BiondVax Pharmaceuticals Ltd.
BiondVax is a 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. For more information, please visit 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 success of the phase 2b clinical trial of the universal vaccine candidate, risks inherent in the development and commercialization of potential candidate products, dependence upon collaborators 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.
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