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JERUSALEM, March 21, 2019 / PRNewswire / – BiondVax Pharmaceuticals Ltd. (Nasdaq developer: BVXV), announced today that all participants had completed their last visit as part of a Phase 2 clinical trial conducted by several units of treatment and badessment of the Immunization (VTEUs) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH) of the US Department of Health and Human Services (HHS).
120 participants aged 18 to 49 were enrolled in the VTEUs at Baylor College of Medicine in Houston, Texas, the University of Iowa in Iowa City, Iowaand the Cincinnati Children's Hospital Medical Center at Cincinnati, Ohio. Patients were randomized to receive either two doses of M-001 or two doses of a placebo, doses being spaced three weeks apart. Later, around the beginning of the 2018-2019 influenza season, all participants were immunized with quadrivalent quadrivalent influenza vaccine currently marketed. The safety and immunogenicity will be evaluated and compared between groups receiving M-001 and placebo. Laboratory badyzes of the immunogenicity of the vaccine will be conducted in the VTEUs at Baylor College of Medicine and St Louis University (St. Louis, Missouri) and at BiondVax Pharmaceuticals. The results are expected by the end of 2019.
Dr. Tamar Ben-Yedidia, Scientific Director of BiondVax, commented: "We are pleased with the progress of this phase 2 trial and grateful to be able to collaborate with NIAID and their researchers."
In parallel, the BiondVax Phase 3 clinical and clinical efficacy trial of Europe , which had recruited 4,094 participants before the 2018/20 influenza season, is heading into its second 2019/20 season. Lot M-001 of the second cohort of the Phase 3 study is being filled with single-use syringes at BiondVax's new medium-sized Israel. The placebo-controlled trial will evaluate the safety and effectiveness of M-001 in reducing influenza and its severity in adults aged 50 years and older. The results are expected by the end of 2020.
About BiondVax
BiondVax (NASDAQ: BVXV) is a clinical-stage biopharmaceutical company developing a universal influenza vaccine. The vaccine candidate, called M-001, is designed to provide multi-layer and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology uses a unique combination of conserved and common influenza virus peptides to stimulate both arms of the immune system for a long-term, cross-protective effect. Out of a total of 6 completed Phase 1/2 and Phase 2 clinical trials, involving 698 participants, the vaccine was found to be safe, well tolerated and immunogenic. The ongoing Phase 3 pivotal clinical trial aims to evaluate the safety and effectiveness of M-001 in reducing the severity of influenza. Please visit www.biondvax.com.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Sector Litigation Reform Act, 1995. Words such as "expect", "believe", "intend", "plan", "continue", "may", "anticipate", and similar expressions These forward-looking statements involve certain risks and uncertainties that reflect management's current views regarding certain current and future events and are subject to various risks, uncertainties and badumptions that could result in a material difference. BiondVax Pharmaceuticals Management's Results and Expected Results Risks and uncertainties include, but are not limited to, the prosecution and results of ongoing Phase 2 and Phase 3 and all subsequent testing. the timing of receipt of regulatory approval of the new manufacturing facility for its products, ability to demonstrate the efficacy and safety of the vaccine; r clinical trials and marketing approvals; the risk that the development of a drug involves a long and costly process with an uncertain outcome; the company's ability to maintain, preserve and defend its intellectual property and issued patents; whether our vaccine candidate will successfully complete the clinical trial process on time or receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information on the risks and uncertainties affecting the Company can be found in the "Risk Factors" section of our annual report on Form 20-F for the year ended December 31, 2017 filed with the US Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the SEC's periodic filings with the SEC. We disclaim any obligation to revise or update any forward-looking statement for any reason.
Contact details
Joshua E. Phillipson
+ 972-8-930-2529
[email protected]
SOURCE BiondVax Pharmaceuticals Ltd.
Related Links
http://www.biondvax.com
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