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GSK Cervical Cancer Candidate Vaccine CERVARIX (R) Demonstrates Long-Term Protection for More Than Six Years
Date:3/10/2008

didate vaccine for the prevention of infection with cancer causing virus types 16 and/or 18, and other cancer-causing virus types, as well as associated Pap smear abnormalities and cervical precancerous lesions. In the extended follow up study, women were evaluated for the presence of human papillomavirus DNA by PCR using cervical samples and annual cervical cytology evaluations were performed. Women were referred for colposcopy following protocol guidelines. Women were also assessed for long-term immunogenicity and safety.

About cervical cancer and its progression

Approximately 100 types of human papillomavirus have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. Virus types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancers globally. Infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous. It is a necessary precursor of cervical cancer. Throughout their lifetime, women may be exposed to cancer- causing virus types and are potentially at risk of developing cervical cancer.

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year. In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.

About the GSK Cervical Cancer Vaccine

To date, CERVARIX(R) has been approved in 55 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in 28 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its ce
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SOURCE GlaxoSmithKline
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