BiondVax Pharma (BVXV) Announces Positive Prelim. Safety Data from M-001 Phase 2b
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) 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.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Herbalife (HLF) Provides Q4, FY17 Guidance in Memorandum for $1.325B Credit Facility; Lowers FY17 Sales Guidance
- Platinum Group Metals Ltd. (PLG) Announces $25M Bought Deal Financing
- Straight Path Communications (STRP) Announces Filing of Universal Shelf Registration
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!