MERIDEN, Conn., Jan. 12, 2017 /PRNewswire/ -- Protein Sciences Corporation, a leading vaccine development company and maker of Flublok Influenza Vaccine®, announced today that its lead protein based Zika vaccine candidate had good safety results and induced strong neutralizing antibodies against the Zika virus in preclinical studies. The product is expected to advance into human clinical trials in the next few months. In addition, the Institute of Technology in Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz), has joined the multinational consortium that is sponsoring development of the vaccine.
The vaccine candidate is composed of purified protein that matches a protein found on the outer surface of the Zika virus (the E protein) and was created using Protein Sciences' proprietary BEVS technology because of its speed, safety and ability to accurately match the field virus. In preclinical testing, the purified protein formulated with alum induced strong levels of neutralizing antibodies in outbred mice, which is a positive indicator that the vaccine will protect against Zika virus infection. In addition, the vaccine candidate demonstrated good safety data in a toxicology study sponsored by National Institute of Allergy and Infectious Disease, National Institutes of Health through its pre-clinical support program. Based on these data, preparations are being made to start a Phase I clinical study in the United States in April 2017.
"Zika remains a substantial threat in several parts of the world," said Manon Cox, President & CEO of Protein Sciences Corporation. "Our new data and Fiocruz, through Bio-Manguinhos´ participation in our consortium bring us another step closer to realizing a vaccine that will protect against this deadly virus."
Protein Sciences Corporation's Zika Consortium consists of five international partners: Mundo Sano and Sinergium Biotech in Argentina, Liomont in Mexico, UMN Pharma in Japan and now Fiocruz in Brazil. Four of these partners are based in Latin America where Zika remains a considerable concern.
Bio-Manguinhos is the Institute of Technology in Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz). Fiocruz is a centennial institution belonging to the Brazilian Ministry of Health with several institutes working on different health related areas (R&D, scientific information, history, education, manufacturing and health care).
Currently, Bio-Manguinhos produces 10 vaccines, 14 in vitro diagnostics (IVDs) and 5 biopharmaceuticals.
See more at www.bio.fiocruz.br
About Protein Sciences
Protein Sciences is a world leader in vaccine development and protein production. Our mission is our inspiration: to save lives and improve health through the creation of innovative vaccines and biopharmaceuticals.
Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, is approved for all adults over 18 years. FDA approved the quadrivalent formulation ("Flublok Quadrivalent") in October 2016 that will be commercially available for everyone over 18 years for the 2017/18 influenza season. Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus, antibiotics or harsh chemicals (e.g., formaldehyde) in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal - a form of mercury), egg proteins, gelatin or latex. In addition, Flublok contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein).* In a 2014/15 post-marketing study of 9,000 adults 50 years and older, people who received Flublok were over 40% less likely to develop cell culture confirmed influenza than people who received a traditional flu vaccine. Flublok is an exact copy of the influenza virus coat protein and is not subject to the egg-adapted mutations associated with low vaccine effectiveness (see Skowronski et al. (2014) PLOS ONE 9(3), e92153).
Healthcare professionals in the U.S. wishing to order Flublok should contact one of the following distributors:
- Protein Sciences Corporation: 203-686-0800 www.flublok.com
- FFF Enterprises: 800-843-7477 www.myfluvaccine.com
- Cardinal Health: 866-677-4844 http://www.cardinal.com/flu
- McKesson: 877-MCK-4FLU mms.mckesson.com
- Moore Medical: 800-234-1464 www.mooremedical.com/flu
- Henry Schein: 1-800-772-4346 www.henryschein.com
Flublok Safety Information
Flublok is approved for people 18 and older to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Headache, fatigue or muscle ache may occur. Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) or have had a severe allergic reaction to any component of Flublok vaccine. Vaccination with Flublok may not protect all individuals. Please see the complete Package Insert available at www.flublok.com or call 203-686-0800 for more information.
*Flublok demonstrated a higher antibody response to the A strains in two field trials in adults ≥50 years old. The B strain antibody responses were comparable to traditional trivalent and quadrivalent vaccines.
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SOURCE Protein Sciences Corporation