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Blog Exposure - BiondVax Pharma Initiated NIH-Sponsored Phase-2 Clinical Trial of M-001 in the US

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Stock Monitor: Dare Bioscience Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 13, 2018 / Active-Investors.com has just released a free research report on BiondVax Pharma Ltd (NASDAQ: BVXV) (''BiondVax''). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BVXV as the Company's latest news hit the wire. On April 11, 2018, the Company declared that it has enrolled first subject in the United States in a Phase-2 clinical trial of the Company's universal flu vaccine candidate, M-001. Conducted under an FDA Investigational New Drug (IND), the trial marks M-001's clinical debut in the US. Register today and get access to over 1,000 Free Research Reports by joining our site below:


Active-Investors.com is currently working on the research report for Dare Bioscience, Inc. (NASDAQ: DARE), which also belongs to the Healthcare sector as the Company BiondVax Pharma. Do not miss out and become a member today for free to access this upcoming report at:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, BiondVax Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

BiondVax to Conduct Pivotal Clinical Efficacy Phase-3 Trial of M-001

News report suggests that on January 24, 2018, BiondVax signed a letter-of-intent (LOI) with a European contract research organization (CRO) aimed at conducting the first pivotal, clinical efficacy, Phase-3 study there assessing M-001 prior to the 2018/2019 flu season. The LOI included a €200K upfront fee to cover startup expenses. In March 2018, BiondVax signed a Master Service Agreement (MSA) with CRO to conduct the Phase-3 trial of M-001. The trial is planned in Europe later in 2018 and is co-funded by the European Union's European Investment Bank (EIB). The trial will enroll 9,630 participants aged 50 years and older across four to six countries over a period of two flu seasons.

About NIAID-Sponsored Phase-2 Clinical Trial

The NIAID-sponsored Phase-2 clinical trial is a multicenter, randomized, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of two doses of M-001, followed by seasonal quadrivalent influenza vaccine. The trial is being conducted at three sites in the United States, which are part of the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs). A total of 120 participants aged 18 to 49 years will be randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced several weeks apart. A few months following the second injection, all participants will receive a currently marketed unadjuvanted quadrivalent seasonal influenza vaccine. Safety and immunogenicity will be assessed and compared between the groups receiving M-001 and placebo.

About M-001

M-001, BiondVax's lead candidate, is comprised of nine epitopes common to influenza virus strains including both influenza Type A and B. In six completed clinical trials in Israel and Europe (two Phase-1/2 and four Phase-2), BiondVax's universal flu vaccine candidate has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains. The Company first looks to obtain regulatory approval for M-001 as a primer to a pandemic or seasonal vaccine, and after accumulating enough safety and efficacy from real world data, the product will be tested and approved as a universal standalone vaccine for any existing or future pandemic or seasonal flu.

About BiondVax Pharmaceuticals Ltd

Founded in 2003 and based in Ness Ziona, Israel, 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.

Stock Performance Snapshot

April 12, 2018 - At Thursday's closing bell, BiondVax Pharma's stock rose 3.34%, ending the trading session at $6.19.

Volume traded for the day: 31.41 thousand shares, which was above the 3-month average volume of 14.94 thousand shares.

Stock performance in the previous three-month period - up 8.79%; and year-to-date - up 15.49%

After yesterday's close, BiondVax Pharma's market cap was at $1.62 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.8% at the end of the session.


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