Protein Sciences Corporation Announces Presentations at ICAAC of Clinical Data on FluBlok®, the First Recombinant Egg - and Additive Free Protection From Influenza, by John Treanor, MD (pandemic formulation) and Lisa M. Dunkle, MD (Seasonal Formulati
Published: Sep 11, 2012
MERIDEN, Conn., Sept. 10, 2012 /PRNewswire/ -- Protein Sciences Corporation announced that this afternoon there will be a presentation of clinical data for the pandemic (monovalent) formulation of Protein Sciences innovative solution for protection from influenza, FluBlok, by John Treanor, MD, Chief of the Infectious Diseases Division of the Department of Medicine at the University of Rochester Medical Center. The presentation will occur at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Entitled "Safety and Immunogenicity of a Recombinant Hemagglutinin (rHA) Pandemic H5N1 Influenza Vaccine", the presentation will occur in Session 114 Vaccines: Innovations, Impact and Safety at 3:00 pm in Room 121 of the Moscone Center in San Francisco.
FluBlok has been developed by Protein Sciences and is made using modern recombinant technology. It is highly purified, sterile and non-infectious and does not contain egg or other extraneous proteins, preservatives (such as Thimerosal) or antibiotics. Protein Sciences anticipates that FluBlok will receive FDA approval in the next few months and, if that occurs, it will have a limited number of doses available during the 2012-2013 influenza season.
Protein Sciences also announced that Lisa M. Dunkle, MD, Chief Medical Officer and Daniel Adams, Executive Chairman of Protein Sciences will present Phase III clinical data of the seasonal (trivalent, non-adjuvanted) formulation of FluBlok at 11:30 am on Tuesday, September 11 in the Product Theater Room in the Exhibit Area at ICAAC. Lunch will be served to early arrivals. More information can be obtained at the Protein Sciences booth No. 1420.
Protein Sciences further announced that Protein Sciences Europa, the European affiliate of Protein Sciences received acceptance from the European Medicines Agency of its Pediatric Investigative Plan for FluBlok. This approval sets the stage for submission of a regulatory filing for licensure of FluBlok in the European Union (E.U.). Protein Sciences Europa anticipates applying for E.U. approval early in 2013.
Protein Sciences Corporation is a vaccine development and protein production company based in Meriden, CT that is dedicated to saving lives and improving health through the creation of innovative vaccines and biopharmaceuticals. Our proprietary baculovirus expression vector system (BEVS) technology provides a fast, reliable and inexpensive platform for the production of high quality recombinant proteins, making it a powerful tool for producing vaccines and therapeutics when they are needed most. BEVS technology is covered by broad patents that include our proprietary expresSF+® cell line that we use to make all of our products.
Our lead product, FluBlok, is a recombinant trivalent vaccine for seasonal influenza, consisting of recombinant influenza hemagglutinin (rHA) proteins that are manufactured using cell culture instead of eggs. FluBlok is highly purified, does not include thimerosal or antibiotics, and is low in endotoxins. FluBlok, which has shown exceptional performance in clinical trials, is under final review by the U.S. Food and Drug Administration.
In 2009, we received a $147 million five-year contract award by the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services, to further develop our technology for the production of recombinant influenza vaccines for pandemic preparedness. Budgets totaling more than $80 million have thus far been approved to support work through at least mid-2013.
Learn more at www.proteinsciences.com.
SOURCE Protein Sciences Corporation