Philadelphia, Pennsylvania (ots/PRNewswire)
- Study to Compare Immunogencity of GSK's Cervical Cancer
Candidate Vaccine, CERVARIX(R), to Merck's Gardasil(R)
GlaxoSmithKline (NYSE: GSK) announced today the initiation of the
first study of its kind designed to compare the immunogenicity of its
cervical cancer candidate vaccine, CERVARIX(R), versus Gardasil(R).
The primary objective of the head-to-head trial is to compare the
immune responses to HPV types 16 and 18 in U.S. women 18 to
26-years-old. Secondary objectives include evaluating the immune
responses to HPV 16 and 18 in women 27 to 35-years-old and 36 to
45-years-old. In addition, the study will compare immune responses to
other cancer-causing HPV types. Initial study results are anticipated
12 months after study enrollment is completed, and extended follow up
will continue for another 17 months.
"Vaccination to prevent cervical cancer may be the most
significant healthcare breakthrough for women in our lifetime," said
Dr. Mark M. Blatter, Medical Director of Primary Physicians Research
in Pittsburgh, PA and study investigator. "This unprecedented trial,
which will enroll more than 1,000 women, will provide the first
scientific evidence to demonstrate how the two vaccines differ with
respect to inducing strong and sustained immune responses in women
who may be appropriate for vaccination."
Data published in Vaccine in August 2006 demonstrated GSK's
cervical candidate vaccine, formulated with the proprietary adjuvant
system AS04, induced higher antibody levels and more robust immune
memory response compared to the same HPV vaccine composition
conventionally formulated with aluminium hydroxide adjuvant alone.
Furthermore, data published in The Lancet in April 2006 provided
evidence that GSK's cervical cancer candidate vaccine demonstrated
protection up to 4.5 years against persistent infection with HPV 16
and HPV 18 - the two most common cancer-causing HPV types - and
protection from pre-cancerous lesions. Protection was also
demonstrated against infection with the third and fourth most
prevalent cancer-causing types of HPV, namely types 45 and 31.
Collectively, HPV types 16, 18, 45 and 31 are responsible for
approximately 80 percent of cervical cancer cases globally.
"GSK is focused on protecting women from cervical cancer, a
devastating disease that often strikes women in the prime of their
lives," said Gary Dubin, Vice President, HPV Vaccines,
GlaxoSmithKline. "By conducting this study, we hope to further the
scientific understanding of the role of strong and sustained immune
responses to HPV vaccination for the benefit of all women."
Notes to Editors:
About the Study
This is a Phase III, randomized, observer-blind, multicenter
study, to be conducted among 1,042 patients in the United States.
There will be two arms of the study, one arm receiving GSK's cervical
cancer candidate vaccine, one arm receiving Gardasil(R), and each arm
will be stratified by age (18-26 [n=374], 27-35 [n=334], 36-45
[n=334]). The primary objective of the study is to compare GSK's
cervical cancer candidate vaccine to Gardasil(R), in terms of immune
responses to the two most common cancer-causing HPV types 16 and 18,
which are responsible for at least 70 percent of all cervical cancers
worldwide, in adult women aged 18 to 26. Secondary objectives will
assess immune responses to cancer-causing HPV types 16 and 18 in
adult women aged 27 to 35, and 36 to 45 as well as evaluate immune
responses to other cancer-causing HPV types. Results are expected 12
months after patient enrollment is complete, with extended follow up
continuing for approximately 17 months after the last study visit
(month 7 through month 24).
About Cervical Cancer
The American Cancer Society estimates that in 2006, nearly 10,000
women were diagnosed with cervical cancer and nearly 4,000 died from
this disease in the Unites States in a single year. After breast
cancer, cervical cancer is the second most frequently occurring
cancer in women ages 20 to 39 in the United States.
About GlaxoSmithKline's Cervical Cancer Candidate Vaccine
GSK's cervical cancer candidate vaccine was developed to prevent
infection and lesions from the two most prevalent cancer-causing
types of HPV, specifically HPV 16 and 18. It is formulated with the
proprietary adjuvant system, AS04, selected to ensure that this
vaccine confers strong and sustained antibody levels over time.
More than 16,000 women worldwide have been vaccinated with GSK's
cervical cancer candidate vaccine as part of completed and ongoing
clinical trials. Phase III studies are under way in more than 25
countries with more than 35,000 subjects enrolled in ongoing trials.
GSK plans to file a biologics license application for CERVARIX(R)
for U.S. Food and Drug Administration review by April in 2007 for its
cervical cancer candidate vaccine. The company submitted a marketing
application review to the European Agency for the Evaluation of
Medicinal Products in March 2006. Other international regulatory
filings followed in Australia, parts of Asia and parts of Latin
America in March 2006.
In the next two to five years, GSK expects to launch more major
new vaccines in the United States, for example, a vaccine against
rotavirus, an improved flu vaccine for the elderly and a meningitis
combination vaccines for various ages, including infants.
GlaxoSmithKline-one of the world's leading research-based
pharmaceutical and healthcare companies-is committed to improving the
quality of human life by enabling people to do more, feel better and
live longer. For company information, please visit www.gsk.com
GSK Biologicals (GSK Bio), one of the world's leading vaccine
manufacturers, is headquartered in Rixensart, Belgium, where the
majority of GlaxoSmithKline's activities in the field of vaccine
research, development and production are conducted. GSK Bio employs
more than 1,500 scientists, who are devoted to discovering new
vaccines and developing more cost-effective and convenient
combination products to prevent infections that cause serious medical
problems worldwide. In 2005, GSK Bio distributed more than 1.2
billion doses of vaccines to 165 countries in both the developed and
the developing world, an average of more than 3 million doses per
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that
any forward-looking statements or projections made by the company,
including those made in this Announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from
those projected. Factors that may affect the Group's operations are
described under 'Risk Factors' in the 'Operating and Financial Review
and Prospects' in the company's Annual Report on Form 20-F for 2005.
ots Originaltext: GlaxoSmithKline GmbH & Co. KG
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