New Research Further Supports Cervarixtm In Protecting Against Cervical Cancer

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Pharma Industry / Biotech Industry
Article Date: 05 Oct 2007 - 18:00 PDT

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New clinical data presented at the European Research Organisation on Genital Infection and Neoplasia congress (EUROGIN) shows that the majority of women could potentially benefit from vaccination against cervical cancer with CervarixTM, GSK's cervical cancer vaccine which is indicated to prevent precancerous lesions and cervical cancer caused by human papillomavirus (HPV) types 16 and 18.

GSK is launching CervarixTM to healthcare professionals at EUROGIN after the European Commission granted Marketing Authorisation, for all 27 European member states* on the 20th September 2007. CervarixTM is indicated for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to HPV types 16 and 18. The indication is based on demonstration of efficacy in women aged 15-25 years following vaccination with CervarixTM and on the immunogenicity of the vaccine in girls and women aged 10-25.1 With first national launches underway, physicians and healthcare professionals can now choose to vaccinate with CervarixTM, which has been developed using new adjuvant technology, the AS04 system. This adjuvant system is specifically designed to induce a stronger and more sustained immune response compared to the same vaccine antigens formulated with conventional aluminum hydroxide adjuvant 2.

During EUROGIN four sets of clinical data were presented which focused on CervarixTM.

The first of these data sets, from two phase III clinical trials involving over 24,000 women of a broad age range (including women over 25 years of age), show that at the time of vaccination, less than one percent of women are actively infected (DNA positive) with both HPV 16 and 183. This highlights that the vast majority of women should benefit from a preventive approach against cervical cancer caused by HPV 16 and 18. In most women, the absence of simultaneous infections with both HPV 16 and 18, at the time of vaccination, confirms that testing women routinely for current HPV infection before vaccination should not be required. The Advisory Committee on Immunization Practices (ACIP) already recommends in its guidelines that women aged 9 to 26 do not need to be tested for current or previous HPV infection before vaccination.4

Secondly, data on vaccine efficacy from the phase III study in women aged from 15-25 years suggests that women who are not currently infected (DNA negative) could benefit from vaccination against cervical cancer with CervarixTM irrespective of their pre-vaccination HPV-16/18 exposure status (sero negative or positive).5

"These data suggest that the majority of women could benefit from vaccination with CervarixTM," commented Diane Harper, Professor of Community and Family Medicine & Obstetrics and Gynecology, Norris Cotton Cancer Center, Dartmouth College, U.S.A. Professor Harper added: "These data help to answer some key questions that physicians confront on a regular basis - we now see the potential benefit that CervarixTM offers to women, regardless of previous exposure status at the time of vaccination".

Thirdly, continued follow-up data of women aged 15-55 vaccinated with CervarixTM were also presented at the congress: CervarixTM was found to be highly immunogenic in a broad age range of women irrespective of their serostatus at the time of vaccination.3,6

Finally data were also presented from an ongoing trial in women over the age of 26, which confirm that CervarixTM was generally well-tolerated7. This further builds on previous safety data which has shown that CervarixTM is well-tolerated in women up to the age of 25, even if they have a current or previous infection.8

GSK Launches "HPV in Cervical Cancer Research Grant"

GSK confirmed its commitment to research and development in HPV and cervical cancer prevention at EUROGIN. Harald zur Hausen, Professor Dr.med. Dr. h.c. mult, from the German Cancer Research Center, Heidelberg Germany announced the launch of the "HPV in Cervical Cancer Research Grant", sponsored by an educational grant from GSK. Professor zur Hausen will lead an independent Scientific Experts Committee who will evaluate applications for the grant. Applicants can apply for funding of 100,000 Euros, for a science research project on any aspects of HPV related cervical cancer. Applications will be received from November 19, 2007 with more information available online and applications will be accepted until February 2008. The winning project will be announced at the HPV in Human Pathology congress, Prague, May 1-3, 2008. Further information on the grant will be available online in November (http://www.path.cam.ac.uk/~stanley/hpvgrant/).

* The EU marketing authorisation which was granted on the 20th September will also have consequent effect in Iceland, Norway and Liechtenstein

About Cervarix™ (Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, adjuvanted adsorbed))

CervarixTM Summary of Product Characteristics attached for further information

CervarixTM is indicated in the EU for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18.1

In May 2007, CervarixTM was granted its first licence in a major market 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 to 45 years.9 Subsequent licenses have been granted in the Philippines, Kenya and the United Arab Emirates.

GSK was granted Community Marketing Authorisation in Europe on the 20th September 2007 and submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007. Other regulatory filings include many additional countries in Africa, Asia and Latin America.

About cervical cancer

Cervical cancer is the second most common cancer in women under 45, and causes over 270,000 deaths worldwide per year10. It occurs when infection with the human papillomavirus becomes persistent, and progresses to cancer. Up to 75 percent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.11,12,13,14 Approximately 100 types of human papillomavirus have been identified to date and, of these, approximately 15 virus types are considered to cause cervical cancer15,16. Virus types 16 and 18 are responsible for approximately 71.5 percent of cervical cancers in Europe.15

About GlaxoSmithKline and GlaxoSmithKline Biologicals

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/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 from up to six diseases in one vaccine.

CervarixTM is a trademark of the GlaxoSmithKline group of companies.

References:

1. Approved European Cervarix Summary Of Produce Characteristics - September 2007

2. Giannini SL et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminum salt combination (AS04) compared to aluminium salt only. Vaccine 2006 24: 5937-5949

3. Skinner R et al. Estimating prior HPV-16/18 exposure by age group of women enrolled in Phase III clinical trials of GSKs HPV vaccine. Presented at EUropean Research Organisation on Genital Infection and Neoplasia congress (EUROGIN) 2007

4. ACIP Guidelines, March 23, 2007/ 56(RR02);1-24

5. Cruickshank M et al. Efficacy and Safety of GSKs HPV Vaccine in women intitially seropositive or seronegative for HPV -16/18 in a Phase III trial. Presented at EUropean Research Organisation on Genital Infection and Neoplasia congress (EUROGIN) 2007

6. Schwarz T et al for the HPV Vaccine Study Group for Adult Women. Immune Response in women up to 55 years of Age Vaccinated with CervarixTM, the HPV-16/18 L1 VLP AS04 Vaccine Candidate. Presented at EUropean Research Organisation on Genital Infection and Neoplasia congress (EUROGIN) 2007

7. Szarewski A et al. Safety of a human papillomavirus (HPV) 16/18 AS04 Cervical Cancer Vaccines Candidate in women aged 26 years or older. Presented at EUropean Research Organisation on Genital Infection and Neoplasia congress (EUROGIN) 2007

8. Paavonen, J et al. Efficacy of a human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) AS04 vaccine: a phase III randomized, controlled trial in young women, Published in June issue of Lancet 2007; 369 (9580) 2161-2170

9. Australian Cervarix Product Information - May 2007

10. Parkin M, Bray F, Ferlay J, Pisani P. Global Cancer Statistics, 2002, CA Cancer J Clin 2005;55: 74-108

11 Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer-burden and assessment of causality. J Natl Cancer Inst Monogr 2003; 31: 3-13.

12 Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med 1997; 102: 3-8.

13 Castle PE et al. A prospective study of age trends in cervical cancer human papillomavirus acquisition and persistence in Guanacaste, Costa Rica. JID 2005: 191: 1808-1816.

14 Castle PE, Schiffman M et al. A prospective study of age trends in cervical human papillomavirus acquisition and persistence in Guanacaste, Costa Rica. Journal of Infectious Diseases 2005; 191; 1808-1816

15 Muñoz N et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. New England Journal of Medicine 2003; 348: 518-527

16 Walboomers JM et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999; 189: 12-19

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