Promising Data Presented on Cervical Vaccine for Women Over 25

GlaxoSmithKline has announced that data from a clinical trial examining the immune response in women aged 26-55 demonstrated that the company's cervical cancer candidate vaccine is highly immunogenic and well-tolerated. The data, presented at the 2006 American Society of Clinical Oncology annual meeting in Atlanta, add to the growing body of evidence supporting the vaccine's ability to provide strong and sustained immune response in women of all ages, a company news release stated.

In this Phase III clinical study, 666 women from Germany and Poland aged 15 to 55 received 3 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% 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.

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 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 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 per cent 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," said Prof. Dr. Tino F. Schwarz, Stiftung Juliusspital Wuerzburg, Germany, the lead study investigator. "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." 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. It 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 per cent 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. GSK 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.

Dr. Philippe Monteyne, Head of Global Vaccine Development of GSK Biologicals, added that "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." 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. 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.