GSK Cervical Cancer Candidate Vaccine CERVARIX (R) Demonstrates Long-Term Protection for More Than Six Years

Tuesday, March 11, 2008 General News
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TAMPA, Fla., March 10 New data demonstrate thatGlaxoSmithKline's (NYSE: GSK) cervical cancer candidate vaccine, CERVARIX(R)provides significant protection for women against the four most common cancer-causing human papillomavirus types for nearly six and a half years, thelongest duration of protection reported to date. Over this time, the cervicalcancer candidate vaccine showed 100 percent efficacy in preventingprecancerous lesions due to cancer-causing virus types 16 and 18 and alsoprovided substantial protection against infection caused by virus types 31 and45.

These data show that virtually 100 percent of women in the study, 15-25years of age, maintained high levels of antibodies against both virus types 16and 18 at every time point for nearly six and half years. This signifies thelongest duration of consistently high antibody levels demonstrated by acervical cancer vaccine. Antibody levels remained several times higher thannatural infection levels over the extended period of time.

"With this trial, we continue to see high levels of antibodies that lastedover time in virtually all women studied, which is critical for the preventionof cervical cancer," said Diane Harper, MD, Norris Cotton Cancer Center,Dartmouth-Hitchcock Medical Center, NH. "These data are remarkable as theyshow the potential for this cervical cancer vaccine to protect women over thelong term."

The study also confirmed substantial cross-protection for nearly six and ahalf years against incident infection caused by virus types 45 and 31.Specifically, the vaccine showed 78 percent efficacy in preventing incidentinfection caused by virus type 45, and 60 percent efficacy in preventingincident infection caused by virus type 31.

Virus types 18 and 45 are responsible for a significant percentage of aparticularly aggressive and deadly form of cervical cancer known asadenocarcinoma. This type of cervical cancer tends to occur in younger womenand is not well detected by routine screening methods.

"We specifically designed our cervical cancer vaccine with the goal ofproviding long-lasting protection from cervical cancer," said James Tursi, MD,Director of Medical Affairs, North America, GlaxoSmithKline. "These studyresults are important because women remain at risk for infection with cancer-causing virus types throughout their lives, and long-term protection will bean essential component of a successful vaccination strategy."

The results also include safety data from nearly six and a half years,showing that the candidate vaccine had no meaningful differences between thestudy groups and had a favorable overall safety profile.

These data were presented today at the Society of Gynecologic Oncologists(SGO) annual meeting in Tampa, FL.

Notes to editors

About the study

This was an extended follow-up (EFU) analysis of women who participated inthe initial efficacy study of GSK's cervical cancer candidate vaccine. Theinitial study was a double-blind, controlled trial of 1,113 young womenbetween 15-25 years of age, randomized to receive three doses of the GSKcandidate vaccine for cervical cancer formulated with the AS04 adjuvantsystem, or three doses of placebo on a 0, 1 and 6 month schedule.

This extended follow-up study looked at study endpoints for 776 women fromthe same cohort of women for a period of up to 76 months. The trial wasconducted in 28 centers in Brazil, Canada and the U.S. and evaluated theefficacy, safety and immunogenicity of GSK's cervical cancer candidate vaccinefor the prevention of infection with cancer causing virus types 16 and/or 18,and other cancer-causing virus types, as well as associated Pap smearabnormalities and cervical precancerous lesions. In the extended follow upstudy, women were evaluated for the presence of human papillomavirus DNA byPCR using cervical samples and annual cervical cytolog

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