Protein Sciences Announces FDA Clearance to Conduct Proof of Principle/Field Trial of FluBlok(TM), its Cell-Culture Influenza Vaccine Enrollment of Subjects to Begin This Week at Three Sites



    MERIDEN, Conn., Oct. 28 /PRNewswire/ -- Protein Sciences Corporation, a
 world leader in developing the next generation of human and veterinary
 vaccines, announced today that it had received FDA clearance to conduct a
 Phase II/III proof of principle/field study of FluBlok(TM), its patented cell
 culture influenza vaccine.  The randomized, double blind, placebo controlled
 trial will be conducted in subjects aged 18-49 and will compare two different
 doses of FluBlok with a placebo group.  The primary endpoints are to show
 safety and establish a commercial dose for FluBlok.  A secondary endpoint is
 to establish efficacy under field conditions, which the study is powered to
 demonstrate with statistical significance if the influenza season is
 relatively robust.  The study sites are the University of Rochester, NY (Dr.
 John Treanor, Study Principal Investigator), the University of Cincinnati
 Children's Hospital (Dr. Gilbert Schiff) and the University of Virginia (Dr.
 Frederick Hayden).
     Daniel D. Adams, President and CEO of Protein Sciences stated, "This is a
 very exciting time for us.  Recent events highlight the critical need for
 influenza vaccines made using modern technology and cell culture.  We believe
 that FluBlok is the only vaccine under development that can resolve all of the
 issues associated with the licensed egg-grown vaccines and therefore can
 address the entire potential market, estimated at more than $4 billion, for
 influenza vaccines.  If this trial is successful, we plan to move immediately
 into a pivotal trial that we expect will lead to licensure.  However,
 unfolding events may speed up the process.  He added, "Recent events have
 highlighted our dependence on foreign companies for our influenza vaccines.
 We are, therefore, exceptionally well positioned because we are the only U.S.
 company with a cell culture influenza vaccine in late stage clinical trials,
 the only company conducting a late stage cell culture vaccine trial in the
 U.S. and the only company to have a potential pandemic vaccine tested in
 humans."
     FluBlok is like the licensed egg-grown vaccines because it contains
 antigens (hemagglutinin proteins) that are derived from three strains of the
 influenza virus that are selected for inclusion in the annual influenza
 vaccine by the CDC and the FDA.  FluBlok presents a potential solution to the
 multitude of issues associated with the licensed vaccines that are grown in
 eggs.  FluBlok's antigens are developed using recombinant DNA technology and
 manufactured in cell culture without eggs.  Unlike the licensed vaccines and
 many cell culture vaccines in development, no live influenza viruses,
 biocontainment facilities or harsh chemicals such as formaldehyde are used in
 manufacturing.  FluBlok consists solely of three antigens (proteins) stored in
 sterile buffered salt water and without preservatives such as thimerosal, a
 mercury derivative currently used in egg-production, or adjuvants.  New
 FluBlok vaccines can be developed quickly and safely to address late appearing
 influenza viruses such as A Fujian in 2003-2004 and emerging natural or man-
 made pandemic viruses, as evidenced by Protein Sciences' achievement in making
 a vaccine for the 1997-1998 Hong Kong "Bird" flu in just eight weeks.
     The 2004-2005 trial is being funded by the Company from its revenues,
 although the Company is raising additional capital through Credit Suisse First
 Boston to support future trials and commercial manufacturing.  Seven previous
 clinical trials of FluBlok, all of which were sponsored by the National
 Institute of Allergy and Infectious Diseases (NIAID), a division of the
 National Institutes of Health, showed safety and generation of antibody titers
 that are accepted as being protective against influenza.  The latest trial was
 conducted in approximately 400 elderly subjects in 2003-2004 and compared a
 licensed egg-grown vaccine with three different doses of FluBlok containing
 the same hemagglutinin antigens.  The data showed that all doses of FluBlok
 were safe and achieved antibody levels that are believed to be associated with
 better protection against an H3 influenza virus(1) than subjects receiving the
 licensed vaccine.  Historically, 30% to 50% of elderly subjects vaccinated
 with the licensed vaccines achieve protective titers against the H3 strain
 and, therefore, the goal was to show that at least 50% to 70% (20% more) of
 subjects vaccinated with FluBlok would achieve protective titers.  Subjects
 receiving the highest doses of FluBlok exceeded the 20% goal -- 77% and 97%,
 respectively, of the subjects achieved protective titers as measured by
 Geometric Mean Titer, a common measure of vaccine effectiveness.   Three
 additional studies over the next 12 months have been committed to by NIAID:
 one in B cell lymphoma patients that is underway; one using the Company's H5N1
 -- A Vietnam "bird flu" vaccine and a follow-on trial in the elderly that will
 involve revaccination and pre-vaccination stratification for antibody levels.
 
     About Protein Sciences.  Founded in 1983, Protein Sciences is a vaccine
 company focused primarily on using modern technology to make the next
 generation of safer and more effective human and animal vaccines.  The Company
 has a pipeline of patented products that includes two influenza vaccines that
 have completed Phase II(b) human clinical trials, one of which, FluBlok, has
 entered Phase II/III trials, and a SARS vaccine and erythropoietin that have
 completed animal tests and will enter human testing soon.  All products are
 recombinant proteins that are made using the Company's patented protein
 expression technology, the baculovirus protein expression system (BEVS), in
 which it is the world leader.  Protein Sciences also has service businesses
 that are driven by its BEVS technology including GeneXpress(R) (developing and
 manufacturing vaccines, therapeutics and diagnostics for customers) and
 manufacturing and selling proteins related to HIV/AIDS, SARS, influenza and
 pandemic influenza for research use.  The Company has developed all of its
 products and businesses internally and retains commercial rights to its major
 products. Its facilities are located in Meriden, CT and include offices,
 research and development laboratories and a cGMP pilot plant capable of
 manufacturing clinical materials at the 600-Liter scale.  Website:
 http://www.proteinsciences.com.
 
       (1) The H3 strain causes the majority of the 20,000 to 70,000 excess
           influenza-related deaths each year in the U.S., more than 90% of
           which occur in the elderly.  In the 2003-2004 influenza vaccine was
           A Panama and in the 2004-2005 vaccine was changed to A Wyoming.
 
 

SOURCE Protein Sciences Corporation

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