2014

Protein Sciences Announces Excellent Efficacy Results for FluBlOk(TM), its Recombinant Influenza Vaccine

    MERIDEN, Conn., June 14 /PRNewswire/ -- Protein Sciences Corporation
 announced today preliminary results from its first field efficacy study of
 FluBlOk(TM), a patented influenza vaccine that is produced in insect cells
 without live influenza viruses, eggs or preservatives such as thimerosal.  The
 study enrolled 460 healthy subjects aged 18 to 49 into three equal arms at
 three sites in the United States during the 2004/05 influenza season.
 Subjects received one of the two different doses of FluBlOk (the concentration
 of the H1 and B antigens was different and the H3 antigen the same in the two
 FluBlOk formulations) or placebo.  The study subjects were followed for
 influenza-like illnesses (ILI) and those who developed ILI were cultured to
 confirm that their illness was influenza.
     The study met its primary endpoints by showing safety and inducing strong
 titers against influenza in all vaccinated subjects that correlate with
 protection.  FluBlOk containing higher amounts of the H1 and B antigens was
 100% efficacious in preventing culture positive influenza illness, the FDA
 standard measure of efficacy.  This was statistically significant compared to
 placebo (p=0.0146).  FluBlOk also significantly reduced the overall occurrence
 of CDC-defined ILI compared to placebo, the established measure of vaccine
 effectiveness.  FluBlOk was more than 85% efficacious against culture positive
 influenza illness in the combined vaccine group (2/301 vs. 7/153 placebo),
 which also was statistically significant relative to placebo (p=0.0083).  A
 comparison group using the 2004/05 egg-grown vaccine could not be included in
 the study because of the vaccine shortage, but the results with FluBlOk are as
 good as or better than what would be expected with the licensed vaccine.
 Final immunologic laboratory assessments and full clinical data audits are
 still in progress.
     "We are extremely pleased with these results that matched even our most
 optimistic scenario," said Daniel D. Adams, Protein Sciences President and
 CEO. "We showed that FluBlOk provides a clear dose-response effect for the H1
 and B antigens, which we demonstrated previously for the H3 antigen.  It is
 especially significant that in such a small study the results show that
 FluBlOk is protective under field conditions and strongly suggest that FluBlOk
 can provide protection that is superior to the licensed influenza vaccines."
 He added, "It is now reasonable to think in terms of applying for licensure of
 FluBlOk in the next few years."
     The Principal Investigator of the study, Dr. John Treanor, Professor of
 Medicine, Infectious Disease Unit, University of Rochester Medical Center,
 said, "The results of this study are very impressive and clearly show that
 FluBlOk had a protective effect against culture-positive illness meeting the
 CDC-ILI case definition."  He added, "The study shows that the baculovirus
 expressed hemagglutinin induces a high level of protective immunity in humans
 and that the lack of a neuraminidase in FluBlOk does not compromise the
 protective effect.  This represents an important validation of the baculovirus
 approach for the next generation of flu vaccine.  The FluBlOk approach is also
 uniquely well suited for the challenges that pandemic influenza poses, so the
 results of this study are especially important as we consider our responses to
 this looming threat."
     In addition to Dr. Treanor, the clinical investigators included Dr.
 Gilbert Schiff at the University of Cincinnati Children's Hospital and Dr.
 Frederick Hayden at the University of Virginia. Eight previous clinical trials
 under which approximately 1,200 healthy adult and elderly and
 immunocompromised subjects were vaccinated with various formulations of
 FluBlOk have been conducted Division of Microbiology and Infectious Diseases
 (DMID), a division of the National Institute of Allergy and Infections
 Diseases, National Institutes of Health.  These studies all show that FluBlOk
 is safe and that vaccinees develop antibodies that are believed to be
 protective against influenza.  A DMID trial in the elderly in 2003 showed that
 higher doses of FluBlOk can be safely administered to elderly subjects,
 generate antibody titers that are significantly more immunogenic than licensed
 vaccines and could protect up to 97% of the elderly against influenza.  Two
 DMID clinical trials of monovalent FluBlOk designed to protect against an H5N1
 potential pandemic influenza strain were conducted in over 200 subjects.  A
 high percentage of subjects receiving two doses of vaccine generated
 antibodies that are believed to be sufficient to protect against the lethal
 virus.  We plan to conduct further studies in the United States and elsewhere
 in all age groups including "at risk" populations such as young children and
 asthmatics with the expectation of applying for licensure in the United States
 in the next few years.
 
     Protein Sciences is a world leader in developing recombinant human and
 veterinary vaccines, therapeutics and diagnostics using its proprietary
 baculovirus expression vector system technology.
 
 

SOURCE Protein Sciences Corporation

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