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Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix,Provides Excellent Protection Against Lesions Caused by Most Common,Cancer-Causing Virus Types

Results also show significant additional protection against infection with virus types beyond 16 and 18 with the GSK cervical cancer candidate vaccine

PHILADELPHIA, June 27, 2007 /PRNewswire-FirstCall/ -- Results from an interim analysis of a Phase III study show that CERVARIX(R), the GlaxoSmithKline cervical cancer candidate vaccine, provides up to 100 percent protection against advanced precancerous lesions caused by the most common types of human papillomavirus, types 16 and 18. The study also strengthens earlier preliminary evidence that the vaccine provides significant protection against infection with additional cancer-causing virus types. These results were published today in The Lancet. "This landmark trial has provided important new insights into the natural history of cervical lesions, and helps us to more clearly understand the causal link between these lesions and the virus types detected within them," said Gary Dubin, M.D., Vice President, North American Clinical Development, GSK.

"These results validate our previous clinical findings, and we believe that the data in this study show the GSK candidate vaccine provided 100 percent protection against precancerous lesions caused by virus types 16 and 18, which are responsible for 70 percent of all cervical cancers," commented David Stout, President of Pharmaceuticals Operations, GSK.

In this study, the majority of precancerous lesions included in the primary analysis had multiple cancer-causing virus types detected, making it difficult to clearly determine which virus type was the cause of the lesion. The observation of such a high number of lesions with multiple virus types was not expected based on published data. This necessitated additional analyses to determine which virus type was the cause of the lesion. In these analyses, causality was determined by confirming the presence of the virus in both the lesion and in previous Pap smear
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