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New data provides additional support confirming CERVARIX™ demonstrated protection against HPV type 45, linked with the most aggressive form of cervical cancer
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Mississauga, July 6, 2010 - The end-of-study results of the largest efficacy trial of a cervical cancer vaccine presented at a major international congress provides additional support confirming that CERVARIX™ demonstrated protection against human papillomavirus (HPV) types 18 and 45, which are linked to the most aggressive form of cervical cancer, along with virus type 16 and 31.
Similar to previous study findings, the end-of-study results show that CERVARIX™ demonstrated protection against the most common cervical cancer causing HPV types (16, 18, 31, and 45) after 48 months of follow-up.* Protection against types 16, 18 and 45 is especially important as these are associated with adenocarcinoma, the most aggressive type of cervical cancer which is more common in younger women and also more difficult to detect through screening. Therefore a vaccine that offers protection against these three virus types could help to significantly reduce the incidence of this aggressive cervical cancer.
Commenting on the significance of the study results, Dr. Barbara Romanowski, study investigator from the University of Alberta, said, "Even though Cervarix is designed to protect against two HPV strains (HPV 16 and 18), the results from this study demonstrate that the vaccine provided protection against the four most common strains of the cervical cancer-causing virus. This is tremendous news for women as it indicates the vaccine could offer them additional protection against cervical cancer beyond what had at first been anticipated and significant protection against the most aggressive form of the disease."
Other data presented at the 26th International Papillomavirus Congress (IPC) included results from the 24-month data from the first, large-scale comparative trial (HPV 010) of immunogenicity and safety between the two licensed cervical cancer vaccines.
Dr. Tjark Reblin, Vice-President, Medical and Chief Medical Officer, GlaxoSmithKline Inc. said, "The data presented at IPC mark a significant milestone for Canadian women. The end of the largest efficacy study of a cervical cancer vaccine confirms the unique cross-protective benefits of the vaccine. What is most significant about this data is that it demonstrates that GSK and Cervarix are delivering on the promise to help protect women against cervical cancer - a disease that kills one woman every day in Canada."
About CERVARIX™
CERVARIX™ is a vaccine indicated in females from 10 to 25 years of age for the prevention of cervical cancer (squamous cell cancer and adenocarcinoma) by protecting against the following precancerous or dysplastic lesions caused by oncogenic Human Papillomavirus (HPV), types 16 and 18: cervical intraepithelial neoplasia (CIN) grade 2 and grade 3, cervical adenocarcinoma in situ (AIS), and cervical intraepithelial neoplasia (CIN) grade 1. In an additional analysis, statistically significant vaccine efficacy in the prevention of CIN2/3 or AIS associated with HPV-31 and HPV-45 was demonstrated in the ATP and TVC cohorts, respectively.
CERVARIX™ is generally well tolerated. The most commonly reported adverse events within 7 days of vaccination with Cervarix™/control (500 (micro)g Al(OH)(3)): local (pain (91.8%/87.2%), redness (48.0%/24.4%) and swelling (44.1%/21.3%)); and general (fatigue (55.0%/53.6%), headache (53.4%/61.4%)).
For more information about CERVARIX™, please visit www.cervarix.ca.
For More Information Contact :
GlaxoSmithKline Inc.
Corporate Communications
905-819-3363
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