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GlaxoSmithKline's Vaccine Formulated with Proprietary Adjuvant Elicits Enhanced and Sustained Immune Response Against Cancer Causing Human Papillomavirus

  Data Presented at the AACR International Conference on Frontiers in Cancer
                             Prevention Research

    PHILADELPHIA, Nov. 1 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK)
today presented data showing that its investigational human papillomavirus
(HPV) 16/18 L1 vaccine formulated with an innovative adjuvant, AS04, induced a
stronger immune response, when compared to the same vaccine formulated with
aluminum salt alone.  This stronger response was sustained over 3.5 years post
vaccination in women.  These results, based on three separate assessments,
including in-vitro evaluation of biological activity of AS04, induction of
anti-HPV 16 and HPV 18 antibodies and inhibition of major neutralizing
epitopes in animal and human subjects, were presented today at the American
Association for Cancer Research (AACR) International Conference on Frontiers
in Cancer Prevention Research in Baltimore, Maryland, as well as communicated
at ECCO 10, the congress of the Federation of European Cancer Societies, in
Paris, France.
    "In the field of vaccinology, GlaxoSmithKline continues to innovate.  GSK
has been developing new adjuvant systems for more than a decade.  For our
cervical cancer vaccine we pursued the objective of inducing a strong immune
response and protection that lasts.  We are encouraged by an enhanced antibody
response we saw with an HPV vaccine formulated with our novel adjuvant," said
Gary Dubin, Vice President, HPV Vaccines, GlaxoSmithKline.  Cervical cancer is
lifelong concern for women and GlaxoSmithKline is committed to lessening the
burden of this disease for women worldwide.
    HPV is the leading cause of cervical cancer.  Seventy seven percent of all
cervical cancer cases are associated with only two oncogenic types, HPV 16 and
HPV 18*.  GlaxoSmithKline's cervical cancer vaccine candidate targeting these
two oncogenic HPV types is currently undergoing Phase III clinical trials
involving more than 28,000 women worldwide.

    About the studies
    Three separate methods were used to evaluate the ability of an HPV 16/18
L1 vaccine formulated with either the AS04 adjuvant, composed of aluminum plus
3-deacylated monophosphoryl lipid A (MPLTM), or aluminum salt alone to induce
an immune response of high magnitude and persistence.
    Activation of the immune system by AS04 or aluminum salt alone was
assessed in-vitro using the human monocyte cell line U937.  Using a common
immunology test, an ELISA (Enzyme-Linked Immunosorbent Assay), researchers
evaluated the production of TNF-alpha (Tumor Necrosis Factor-alpha) which is a
key mediator of immunologic functions.  Data demonstrate that AS04 was
associated with substantial and greater induction of TNF-alpha production,
compared to aluminum salt alone.
    In addition, following vaccination with an HPV 16/18 L1 vaccine of mice,
monkeys, and women aged 18 to 30, serum samples were evaluated for antibodies
to HPV 16 and HPV 18 L1 VLPs.  Furthermore, an inhibition ELISA was used for
measure of antibodies specifically directed against the major neutralizing
sites on HPV 16 and HPV 18, known as V5 and J4 epitopes, respectively.  The
findings demonstrate that one month following the second or third vaccine
doses, GlaxoSmithKline's investigational cervical cancer vaccine formulated
with AS04 induced anti-VLP 16 and 18 antibodies that were substantially higher
than with the aluminum salt only formulation.  Additionally, higher levels of
antibodies directed against key V4 and J5 neutralizing epitopes were induced.
Moreover, the higher antibody responses associated with the AS04 formulation
persisted for up to at least 3.5 years post-vaccination in human subjects.

    About Cervical Cancer
    Cervical cancer is a major global health problem, with nearly 500,000 new
cases occurring each year worldwide.  It is the second most common cancer --
and the third leading cause of cancer deaths -- in women worldwide.  In the
United States, approximately 10,000 women will develop cervical cancer this
year, and nearly 4,000 will die from the disease.  HPV is the leading cause of
cervical cancer.  There are many types of HPV; however, 77 percent of all
cervical cancer cases are associated with only two oncogenic types, HPV 16 and
HPV 18.*
    An estimated 20 million people in the U.S. are currently infected with
genital HPV.  HPV infection is very common among sexually active people, with
an estimated 5.5 million new infections occurring every year in the U.S.  In
fact, by the age of 50, approximately 80 percent of women will have been
infected with HPV.  Genital HPV infection is especially common in women under
the age of 25.  HPV infections are usually transient and generally cause no
symptoms.  Persistent infection with oncogenic types of HPV may lead to
cervical cancer.
    Screening for abnormal cervical cells using the Pap smear has
significantly reduced the number of cervical cancer cases in the U.S.
However, there are nearly three million abnormal Pap smears each year, which
may require additional follow-up and treatment.  The total healthcare cost to
evaluate and treat women with abnormal Pap smears in the U.S. has been
estimated at $6 billion annually.  In addition, there are personal and social
costs associated with abnormal pap tests and cervical cancer -- including
emotional distress and anxiety -- which cannot be measured in dollars.

    GLAXOSMITHKLINE: A LEADER IN VACCINES
    GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research
Triangle Park, N.C., is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.

     * Note, 77 percent applies to North America and Australia.


SOURCE GlaxoSmithKline




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CONTACT:
Danielle Halstrom of GlaxoSmithKline,
+1-919-483-2839; or Gina Pozadas of Cohn & Wolfe for
GlaxoSmithKline, +1-212-798-9769