Cervarix, GSK Cervical Cancer Candidate Vaccine, Demonstrates 100Percent Protection Against Precancerous Lesions Caused ByCancer-Causing Human Papillomavirus Types 16 & 18 for More ThanFive YearsNew study results also show evidence of additional protection against infection with other cancer-causing virus types
LOS ANGELES, April 17, 2007 /PRNewswire-FirstCall/ -- The GlaxoSmithKline cervical cancer candidate vaccine, CERVARIX(R), demonstrated 100 percent efficacy in preventing precancerous lesions due to cancer-causing human papillomavirus types 16 and 18 for up to 5.5 years in an extended follow-up trial, according to data presented today at the American Association for Cancer Research. The trial results demonstrate the longest duration of protection seen in any cervical cancer vaccine trial reported to date.
The GSK cervical cancer candidate vaccine also showed 68 percent vaccine efficacy against precancerous lesions (CIN2+) and 38 percent vaccine efficacy against abnormal Pap smears, regardless of the type of cancer-causing virus detected. These results suggest evidence of protection beyond what might be expected from a vaccine that is designed to target virus types 16 and 18 alone. More specifically, the study confirmed that the candidate vaccine provides further preliminary evidence of cross-protection against incident infection with cancer-causing virus types 45 and 31 that also extended up to 5.5 years after vaccination.
"These new data from this extended follow-up trial are exciting for those of us who are working to prevent cervical cancer, and for women around the world," said Dr. Stanley Gall, lead investigator and Professor of Obstetrics, Gynecology and Women's Health at the University of Louisville, Kentucky. "Demonstrating 100 percent efficacy and sustained immune response for more than five years is a significant contribution to the scientific understanding of preventing cervical cancer and precancerous lesions through vaccination."
Additionally, the trial found that the candidate vaccine induced a strong immune response in virtually 100 percent of women in the study, which was maintained over 5.5 years for both virus types 16 and 18. At the end of the 5.5 year observation period, the average level of antibodies against both virus types 16 and 18 was at least 11 times greater than antibody levels associated with natural infection with the virus.
"The results of this study confirm our confidence in our cervical cancer candidate vaccine, which includes a novel proprietary adjuvant system, called AS04, intended to enhance immune response and increase duration of protection," said Dr. Hugues Bogaerts, Vice President of Worldwide Medical Affairs, Human Papillomavirus Vaccines, GSK. "We believe that the best possible prevention of cervical cancer will include routine screening together with a vaccine designed to provide broad and durable protection against the most common cancer-causing virus types."
Notes to editors
About the study
This was an extended follow-up (EFU) analysis of women who participated in the initial efficacy study of GSK's cervical cancer candidate vaccine. The initial study was a double-blind, controlled trial of 1,113 young women between 15-25 years of age, randomized to receive three doses of the GSK candidate vaccine for cervical cancer formulated with the AS04 adjuvant system, 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 from the same cohort of women for a period of up to 67 months. The trial was conducted in 28 centers in Brazil, Canada and the U.S. and evaluated the efficacy, safety and immunogenicity of GSK's cervical cancer candidate 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 considered to cause cervical cancer. Virus types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancers globally. Persistent infection with a cancer-causing virus type leads to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous. Throughout their lifetime, women may be exposed to cancer-causing virus types and are potentially at risk of developing cervical cancer.
Globally, cervical cancer is the second leading cause of cancer death among women 20-39 years of age after breast cancer.
The GSK Cervical Cancer Candidate Vaccine Around the World
In addition to the Biologics License Application submitted for CERVARIX(R) with the U.S. Food and Drug Administration, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and major countries in Asia and Latin America.
GlaxoSmithKline-one of the world's leading research-based pharmaceutical and healthcare companies-is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/.
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 with up to six diseases in one vaccine.
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CONTACT: US Media, Liad Diamond, Nancy Pekarek or Mary Anne Rhyne,+1-919-483-2839, UK Media, Philip Thomson, Joss Mathieson or Gwenan White,+44-20-8047-5502, European Analyst-Investor inquiries, Anita Kidgell,+44-20-8047-5542, or David Mawdsley, +44-20-8047-5564, or Sally Ferguson,+44-20-8047-5543, or US Analyst-Investor inquiries, Frank Murdolo,+1-215-751-7002, or Tom Curry, +1-215-751-5419, all of GlaxoSmithKline
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Posted: April 2007