ATLANTA, June 5 /PRNewswire-FirstCall/ -- The first data to be presented from a clinical trial examining the immune response in women aged 26-55, demonstrated that GlaxoSmithKline’s [NYSE and LSE: GSK] cervical cancer candidate vaccine is highly immunogenic and well-tolerated. The data, presented today at the 2006 American Society of Clinical Oncology (ASCO) annual meeting in Atlanta, GA.[Abstract No: 1008], add to the growing body of evidence supporting the vaccine’s ability to provide strong and sustained immune response in women of all ages.
In this Phase III study, 100 percent of women across all study age groups (15-55 years of age) vaccinated with GSK’s cervical cancer candidate vaccine demonstrated antibody response against HPV 16 and HPV 18 -- the two most common cancer-causing HPV types -- one month after completion of the vaccination course. All women remained seropositive when evaluated at 12 months after the first dose, with antibody levels substantially higher than those reported following natural infection. GSK’s cervical cancer candidate vaccine is formulated with the proprietary innovative adjuvant system AS04, selected to ensure this vaccine confers strong and sustained antibody levels.
These new results suggest that women over 25 years old could also be protected from infection with HPV types 16 and 18 through vaccination. The antibody levels were indeed greater or equal to those observed during a separate long-term follow up efficacy study in which women (15 - 25 years of age) were shown to have 100% protection over 4.5 years against HPV 16 and 18 infections and associated cervical lesions. The data also show that GSK’s cervical cancer candidate vaccine was generally safe and well-tolerated in women of all study age groups, extending the safety profile already demonstrated in former studies. Additionally, the vaccine had already demonstrated substantial protection against incident infection with the third and fourth most prevalent cancer-causing types of HPV, namely types 45 and 31. HPV types 16, 18, 45 and 31 are collectively responsible for 80 percent of cervical cancers globally.
“For the first time, we see that a vaccine against cervical cancer is highly immunogenic in women over 25 years of age. These are important data as older women remain at significant risk of acquiring infections with cancer- causing HPV types. The promising study results suggest that both younger and older women could be protected through vaccination from oncogenic HPV 16 and 18 infections and associated cervical lesions leading to cervical cancer,” said Prof. Dr Tino F. Schwarz, Stiftung Juliusspital Wuerzburg, Germany, the lead study investigator.
“Cervarix(TM) was designed to provide women of all ages with the best possible protection against cervical cancer,” said Dr Philippe Monteyne, Head of Global Vaccine Development of GSK Biologicals. “All women are at risk of developing cervical cancer due to infection by cancer-causing HPV types. These results are encouraging as they open the possibility that all women, regardless of age, would benefit from vaccination against oncogenic HPV infection to protect them against cervical cancer.”
About the study
In this Phase III clinical study, 666 women from Germany and Poland aged 15 to 55 received three doses of GSK’s cervical cancer candidate vaccine at 0, 1 and 6 months. Study participants were age-stratified: 15-25, 26-35, 36-45 and 46-55 years old and were assessed for antibody levels at 7 and 12 months.
Results show that 100 percent of women in this study had detectable antibodies for HPV 16 and 18 at month 7 and 12. The HPV 16 and 18 post-vaccination antibody levels at month 12 were at least 16 to 26 times higher than those reported following natural infection.
The study concludes that GSK’s cervical cancer candidate vaccine is highly immunogenic and generally well tolerated in women 15-55 years old.
About GSK’s cervical cancer candidate vaccine
GSK’s cervical cancer candidate vaccine was developed to prevent infection and lesions from the two most prevalent cancer-causing types of HPV, specifically HPV 16 and 18.
In previous clinical trials performed in 15-25 year old women, the vaccine demonstrated excellent protection from persistent infection against both HPV 16 and 18, associated precancerous lesions and excellent antibody response up to 4.5 years. GSK’s cervical cancer candidate vaccine is formulated with the proprietary adjuvant AS04 selected to ensure that it confers high and sustained antibody levels. In addition, GSK’s cervical cancer candidate vaccine demonstrated substantial protection against infection with the third and fourth most prevalent cancer-causing types of HPV, namely types 45 and 31. HPV types 16, 18, 45 and 31 are collectively responsible for 80 percent of cervical cancers globally.
The overall safety profile from the completed controlled trials indicates that the vaccine is generally safe and well tolerated with a very good compliance to the 3 dose schedule.
Over 16,000 women worldwide have been vaccinated with GSK’s cervical cancer candidate vaccine as part of completed and ongoing clinical trials. It is currently undergoing extended Phase III clinical trials.
GSK’s submitted a marketing application review for its cervical cancer candidate vaccine to the European Agency for the Evaluation of Medicinal Products (EMEA) in March 2006. Other international regulatory filings followed in Australia, parts of Asia and Latin America from March 2006, with submission to the US Food and Drug Administration (FDA) targeted by the end of 2006.
About HPV and cervical cancer
HPV infection is very common; every sexually active woman is at risk of contracting a type of HPV, which may cause cervical cancer. While there are many different types of HPV that may cause cancer, HPV types 16, 18, 45 and 31 are collectively responsible for 80 percent of cervical cancers globally.
Cervical cancer is a major global health problem, with nearly 500,000 new cases occurring each year worldwide. It is the second most common cancer -- and the third leading cause of cancer deaths -- in women worldwide. Each year an estimated 270,000 women die from the disease, and it is the leading cancer killer of women in the developing world.
About GlaxoSmithKline and GlaxoSmithKline Biologicals
In the next five years, GSK expects to launch more major new vaccines: a vaccine against rotavirus (US), a vaccine to prevent pneumococcal disease, an improved flu vaccine for the elderly, and a meningitis combination vaccine for infants.
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 http://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 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.
For further information please contact: US Media enquiries: Danielle Halstrom, +1 919 483 2839, Gina Juliano, +1 212 798 9769, US Analysts/Investors enquiries: Frank Murdolo +1 215 751 7002 Tom Curry, +1 215 751 5419
GSK cautionary statement regarding forward-looking statements Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group’s operations are described under ‘Risk Factors’ in the Operating and Financial Review and Prospects in the company’s Annual Report on Form 20-F for 2005.
GlaxoSmithKline
CONTACT: Media: Danielle Halstrom, +1-919-483-2839, Analysts & Investors:Frank Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419, all ofGlaxoSmithKline; or Gina Juliano of Cohn & Wolfe, +1-212-798-9769,gina_juliano@cohnwolfe.com
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