Issued: Wednesday 14 May 2008, London, UK

Neutralising antibodies are believed by experts to be important for cervical cancer prevention ^1,2,3

New data from an extended follow-up study show that Cervarix generates sustained high levels of neutralising antibodies against the two most common cervical cancer-causing virus types for up to 6.4 years.⁴ This is the longest duration of sustained neutralising antibody levels reported against both virus types HPV 16 and 18 with a cervical cancer vaccine to date.

Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection.¹,^2,3 The World Health Organisation has stated that neutralising antibodies are “considered to be the major basis” of vaccine-induced protection from infection.^2,3

In addition, the study found that the level of total antibodies induced by Cervarix was sustained and 11 times higher than the total antibody levels induced after natural infection for up to 6.4 years.⁴ These new data confirm previous findings from Cervarix studies showing that, when total antibody levels are high, neutralising antibody levels are also elevated.⁵

“The high and sustained neutralising antibody levels seen with Cervarix against both HPV 16 and 18 in this trial are encouraging and may be important for long-lasting protection”, commented Professor Tino Schwarz, Head of the Central Laboratory at the Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany.

This trial included more than 700 women aged 15-25 years. During the same period that Cervarix induced sustained high antibody levels for both HPV 16 and 18, the vaccine has been shown to provide 100 percent efficacy against those cancer-causing virus types.⁴

“We designed Cervarix with our proprietary Adjuvant System, AS04, to deliver high and sustained levels of neutralising antibodies’ said Philippe Monteyne, Senior Vice President, GSK Biologicals. “With nearly six and a half years of data, Cervarix has the longest duration of protection against HPV 16 and 18 reported to date than for any cervical cancer vaccine. The high and sustained neutralising antibody levels we observe over this same period give us great confidence that the vaccine will continue to protect over the longer term. This is why we are extending the study follow-up in a sub-set of women for up to nine and a half years, the longest follow-up period reported for any cervical cancer vaccine”.

These data were presented today at the European Society for Paediatric Infectious Diseases (ESPID) annual meeting in Graz, Austria.

Notes to the editors:

• Safety data from 11 trials involving almost 30,000 women aged from 10-72 years, who received either Cervarix or a control were also presented at ESPID. 6 During the course of vaccination and after the completion of the three-dose schedule no differences were observed between the Cervarix and control groups in serious adverse events, medically significant conditions and new onset of autoimmune diseases. ⁶
• Compliance with the three-dose schedule was excellent in the 11 trials of the integrated safety summary.⁶

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 vaccine, Cervarix.The initial study was a double-blind, controlled trial of 1,113 young women between 15-25 years of age, randomised to receive three doses of Cervarix, formulated with the AS04 adjuvant system, or three doses of placebo on a 0, 1 and 6 month schedule.⁴

This extended follow-up study looked at study endpoints for 776 women from the same cohort of women for a period of up to 6.4 years post-vaccination.The trial was conducted in 28 centers in Brazil, Canada and the U.S. and evaluated the efficacy, safety and immunogenicity of Cervarix for the prevention of infection with cancer causing virus types 16 and/or 18, and other cancer-causing virus types, as well as prevention of 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 according to protocol guidelines.Women were also assessed for long-term immunogenicity and safety.⁴

About cervical cancer and its progression

Approximately 100 types of human papillomavirus have been identified to date7 and, of these, approximately 15 virus types are known to cause cervical cancer.⁸ Virus types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancers globally.⁸ Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.⁹ Human papillomavirus is a necessary precursor of cervical cancer.⁹ Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously. However, if the infection persists it can lead to precancerous lesions or cervical cancer.¹⁰

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.¹¹

About the GSK cervical cancer vaccine

To date, Cervarix has been approved in more than 60 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan. GSK also submitted Cervarix to the World Health Organisation (WHO) for prequalification in September 2007.

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer vaccine in March 2007.

About GlaxoSmithKline

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/media .

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 paediatric vaccines which protect the world’s children with up to six diseases in one vaccine.

Cervarix is a trademark of the GlaxoSmithKline group of companies.

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References

1. Villa L. Vaccines against papillomavirus infections and disease. Revista Chilena de Infectologia. 2006; 23(2): 160-163

2. World Health Organisation Human papillomavirus and HPV vaccines: technical information for policy-makers and health professionals. Retrieved from www.who.int/reproductive-health/publications/hpvvaccines_techinfo/hpvtechinfo_nocover.pdf on 8 February 2008

3. World Health Organisation. Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines. Expert committee on biological standardization, Oct 2006

4. Wheeler C, Teixeira J, Romanowski B et al. High and sustained HPV 16 and 18 antibody levels through 6.4 years in women vaccinated with Cervarix (GSK HPV-16/18 ASO4 vaccine). Abstract at ESPID’s Annual Meeting, May 13-16, 2008, Graz, Austria.

5. Dessy F, David MP, Schuind A et al. Evaluation of HPV neutralizing antibodies from an extended follow up study through 5.5 years in women vaccinated with GSKs prophylactic Cervical Cancer Candidate Vaccine. Presented at IPC 2007

6. Descamps D, Hardt K, Spiessens B et al. Safety of human papillomavirus (Hpv)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Abstract at ESPID’s Annual Meeting, May 13-16, 2008, Graz, Austria.

7. De Villiers EM, Fauquet C, Broker T. Classification of papillomaviruses Virology 2004; 324 17-27

8. Munoz N, Bosch X, Castellasague X. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer 2004; 111: 278-85

9. Bosch FX, Lorincz A, Munoz N et al. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 2002; 55: 244-65

10. GravittPE, Jamshidi R. Diagnosis and management of oncogenic cervical human papillomavirus infection. Infect Dis Clin North Am, 2005; 19:439-458

11. World Health Organization. Initiative for Vaccine Research. www.who.int/vaccine_research/diseases/hpv/en/ Accessed on May 2, 2007