Cervarix, the GSK Cervical Cancer Candidate Vaccine, Provides Sustained Immune Response in 100 Percent of Women up to 55 Years of AgeNew Study Results Show Antibodies Against Cancer-Causing Virus Types 16 & 18 That Are At Least Ten Times Greater Than Natural Infection Levels
CHICAGO, June 05, 2007 /PRNewswire/ -- New Phase III data show that at 18 months after the first of a three-dose regimen, 100 percent of women up to age 55 vaccinated with the GlaxoSmithKline (GSK) cervical cancer candidate vaccine had antibodies present against the two most common cancer-causing human papillomavirus types, 16 and 18. These data indicate that the vaccine, formulated with a proprietary adjuvant system called AS04, is highly immunogenic and generally well-tolerated, with antibody levels at least ten times greater than those produced by natural infection. These new extended follow-up data were presented today at the American Society of Clinical Oncology (ASCO) annual meeting (abstract #3007).
"Previous natural infection with these cancer-causing human papillomavirus types may not confer lifelong protection. Thus, women of all ages may be at risk for future infection," said Prof. Tino F. Schwarz, Stiftung Juliusspital, Wuerzburg, Germany, the lead study investigator. "In fact, the older a woman is when infected, the more likely that the infection will become persistent, which may lead to the development of precancerous lesions. These GSK cervical cancer vaccine study results suggest that many women could potentially benefit from vaccination against cervical cancer."
Furthermore, the study shows that antibody levels in women ages 26 to 55 against cancer-causing virus types 16 and 18 were in the same range as observed in a separate study. That study demonstrated that the GSK cervical cancer vaccine provided 100 percent sustained protection against precancerous lesions caused by these virus types for up to 5.5 years in women ages 15 to 25.
"The results of this study are very promising, as we observed that 100 percent of women in all age groups showed a persistent antibody response to our vaccine," said Barbara Howe, MD, Vice President and Director, North American Vaccine Development Organization, GlaxoSmithKline. "As women age, their immune responses typically decline. We designed our cervical cancer vaccine with an adjuvant system called AS04 which is specifically intended to enhance immune response and increase duration of protection."
Notes to editors:
About the study
Healthy women from Germany and Poland ages 15 to 55 who received three doses of the GSK cervical cancer candidate vaccine at 0, 1 and 6 months in this Phase III clinical study were invited to participate in an extension to the initial study, previously evaluated at 12 months. The 517 women who participated in this follow-up study were age-stratified: 15-25 [n=169], 26-35 [n=83], 36-45 [n=89] and 46-55 [n=176] years old. Immunogenicity and safety were assessed at 18 months after the first dose of a three-dose vaccination regimen.
About the GSK cervical cancer candidate vaccine
GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CERVARIX(R) in March 2007, for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. The BLA includes data from clinical trials in almost 30,000 females ages 10-55 and reflects an ethnically diverse population. The submission also contains data from the largest Phase III cervical cancer vaccine efficacy trial to date, which was conducted around the world in more than 18,000 women ages 15-25. In May, CERVARIX(R) was granted a license by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females ages 10-45 years. GSK has also submitted marketing authorization applications to the European Medicines Agency, Canada and numerous countries in Asia and Latin America.
About cervical cancer
Worldwide, more than 500,000 women are diagnosed with cervical cancer and over 280,000 women die from it each year. In the United States, after breast cancer, cervical cancer is the leading cause of cancer death in women ages 20- 39. Furthermore, approximately two million precancerous lesions are diagnosed each year in the U.S. Cervical cancer and precancerous lesions are a major health, psychological and social burden on women everywhere.
At any given time, only 2.3 percent of women ages 14-59 are currently infected with cancer-causing human papillomavirus types 16 or 18. Only 0.1 percent is currently infected with both types. Therefore, the vast majority of these women (up to 99.9 percent) may benefit from vaccination as they are potentially at risk for developing an infection in the future with these types. Naturally occurring infections with cancer-causing virus types may resolve on their own, but this previous exposure may not protect against future infections with the same virus types. Some infections persist and develop into precancerous lesions, which can advance into cancer. Progression from infection to cervical cancer may take as little as two years.
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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 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.
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Posted: June 2007