Followers | 145 |
Posts | 27558 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Tuesday, November 29, 2016 8:30:04 AM
NESS ZIONA, Israel, November 29, 2016 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today 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.
Recent BVXV News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 04/16/2024 09:27:06 PM
- Scinai to showcase its novel biological local therapeutic for Plaque Psoriasis at Dermatology Drug Development Summit together with Prof. Michael Schön of UMG • PR Newswire (US) • 04/10/2024 11:00:00 AM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 03/12/2024 08:17:13 PM
- Scinai leadership to attend BIO-Europe Spring 2024 • PR Newswire (US) • 03/12/2024 12:00:00 PM
- Scinai Welcomes Liat Halpert as Head of Business Development and Sales • PR Newswire (US) • 02/13/2024 12:00:00 PM
- Scinai Immunotherapeutics Announces Closing of Exercise of Outstanding Warrants for $1.69 Million in Gross Proceeds • PR Newswire (US) • 01/04/2024 09:01:00 PM
- Scinai Immunotherapeutics Regains Compliance with Nasdaq's Stockholders' Equity Rule • PR Newswire (US) • 11/20/2023 12:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 09/07/2023 09:27:02 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/06/2023 04:01:30 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/06/2023 03:44:03 PM
- BiondVax Pharmaceuticals Ltd. Rebrands as Scinai Immunotherapeutics Ltd. to Reflect New Focus on Development of Novel Inflammation and Immunology (I&I) Biological Therapeutics • GlobeNewswire Inc. • 09/06/2023 10:00:00 AM
- Form 424B2 - Prospectus [Rule 424(b)(2)] • Edgar (US Regulatory) • 08/28/2023 08:01:36 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/28/2023 04:15:26 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/24/2023 08:05:06 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/23/2023 10:10:14 AM
- Form F-3 - Registration statement by foreign private issuers • Edgar (US Regulatory) • 08/18/2023 08:16:19 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 08/18/2023 02:07:35 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 08/14/2023 10:08:59 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/11/2023 01:44:48 PM
- BiondVax Reports Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/11/2023 01:00:00 PM
- Nasdaq Grants BiondVax Extension to Regain Compliance with Listing Rules • GlobeNewswire Inc. • 08/01/2023 08:01:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/01/2023 08:00:04 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/12/2023 07:10:31 PM
- IBN Announces Latest Episode of The Bell2Bell Podcast featuring Amir Reichman, CEO of BiondVax Pharmaceuticals Ltd. • GlobeNewswire Inc. • 07/11/2023 12:17:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/05/2023 01:17:40 PM
FEATURED Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • Apr 25, 2024 8:52 AM
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM