Glaxosmithkline Extends Long-term Cervical Cancer Vaccine Clinical Trial For Three Additional Years

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Sep 2007 - 17:00 PDT

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GlaxoSmithKline (NYSE: GSK) announced the extension of a long-term prospective clinical trial to assess the long-term efficacy, immune response and safety of the cervical cancer candidate vaccine, CERVARIX® for three additional years, for a total of up to nine years. The trial, which is a blinded long-term follow-up study of a subset of women who participated in the initial efficacy study and subsequent follow-up study of GSK's cervical cancer candidate vaccine, will continue to evaluate the efficacy of the vaccine in preventing infection with the two human papillomavirus types most commonly associated with cervical cancer, types 16 and 18. Additionally, the study will continue to examine the long-term efficacy of the candidate vaccine in preventing infection with additional cancer-causing virus types beyond types 16 and 18. The study will also examine the long-term immune response and long-term safety profile of the candidate vaccine.

"This long-term trial demonstrates GSK's commitment to providing additional scientific knowledge about the potential of our vaccine to offer strong and sustained protection from cervical cancer, the second most common cause of cancer death among young women," said Barbara Howe, MD, Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We are proud to extend our current study to look even further into the future with respect to our vaccine's potential to provide long-term protection."

This trial will begin in the coming weeks. It includes more than 400 young women initially vaccinated with the GSK cervical cancer candidate vaccine, formulated with the AS04 adjuvant system, or placebo when they were 15 to 25 years of age. Results up to 5.5 years following the first dose of the candidate vaccine/placebo were presented at the American Association for Cancer Research annual meeting in April 2007.

About the study

The initial study was a double-blind, controlled trial of 1,113 young women between 15 to 25 years of age, randomized to receive three doses of the GSK cervical cancer candidate vaccine or three doses of placebo on a 0, 1 and 6 month schedule. The first follow-up study is looking at study endpoints in 776 women from the initial cohort for a total of 6.5 years following the first dose of the candidate vaccine/placebo in the initial trial.

The trial announced today will continue to evaluate more than 400 women from five study centers in Brazil and will closely follow the design of the previous studies to ensure consistency in the collection of long-term data. Objectives will be evaluated for an additional 36 months, providing data for up to a total of approximately nine years after administration of the first candidate vaccine/placebo dose.

About the GSK Cervical Cancer Vaccine

GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asia and Latin America.

In May, CERVARIX was granted its first license 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 aged 10 to 45 years. This is the first time that a cervical cancer vaccine has been explicitly indicated anywhere in the world for women over the age of 26. Subsequent licenses have been granted in the Philippines, Kenya and the United Arab Emirates.

About Cervical Cancer

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year. In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39. Cervical cancer is a major health, psychological and social burden on women everywhere.

Published data from the United States show that at any given time, only 2.3 percent of women ages 14 to 59 are currently infected with cancer-causing human papillomavirus types 16 and 18, which are responsible for 70 percent of all cervical cancers. Only 0.1 percent are currently infected with both types. Therefore, the vast majority of these women (up to 99.9 percent) may benefit from vaccination as they are not actively infected with these virus types and are potentially at risk for developing an infection in the future. Naturally occurring infections with cancer-causing virus types may resolve on their own, but this previous exposure may not protect against future infections with the same virus types. Some infections persist and develop into precancerous lesions, which can advance into cancer.

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 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 pediatric vaccines which protect the world's children from up to six diseases in one vaccine.

CERVARIX is a trademark of the GlaxoSmithKline group of companies.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. 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 'Business Review' in the company's Annual Report on Form 20-F for 2006.

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