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www.fdanews.com/articles/81485-merck-s-gardasil-could-prevent-cervical-cancer-linked-to-hpv

MERCK'S GARDASIL COULD PREVENT CERVICAL CANCER LINKED TO HPV

October 7, 2005

In a late-stage clinical trial, a Merck vaccine that targets the human papilloma virus (HPV) prevented virtually 100 percent of growths that can lead to cervical cancer.

Roughly 20 million U.S. men and women are infected with HPV, certain types of which can cause cervical cancer and genital warts. Even benign cervical changes caused by HPV can generate abnormal test results for women. Merck's vaccine, Gardasil, targets HPV Types 16 and 18, which account for 70 percent of cervical cancers, and HPV Types 6 and 11, which account for 90 percent of genital warts.

Gardasil prevented high-grade (the most serious) precancerous lesions and non-invasive cancers in 97 percent to 100 percent of the women who received Gardasil for the Phase III study, known as Future II. Women were first screened to make sure they did not have HPV, then received either vaccine injections or placebo injections, and were monitored for approximately two years.

Two separate analyses were done for the study. The primary analysis was of the women who remained HPV-free throughout the study and also did not commit any major violations of study protocol. A secondary analysis was done that included the original, HPV-free study group, as well as women who may have become infected during the vaccination period, and women who committed significant violations of study protocol, such as missing a visit.

More than 12,000 women between the ages of 16 and 26 participated in the prospective, randomized, double-blind, placebo-controlled Future II study, part of ongoing Phase III trials that involve more than 25,000 males and females in 33 countries.

The news may serve as a life raft for the embattled drugmaker, which is fighting several lawsuits related to its withdrawn arthritis drug Vioxx (rofecoxib). Merck said it plans to seek FDA approval for Gardasil before the end of the year.

(http://www.fdanews.com/did)