Glaxo SmithKline Plc announced that investigators at more than 90 sites worldwide are commencing a global phase III clinical trial of a new vaccine that could offer protection against developing cervical cancer.
In preliminary studies, the investigational cervical cancer vaccine was well tolerated and appeared to demonstrate clinical benefit.
The study has been given the name "PATRICIA", which is short for "PApilloma TRIal to prevent Cervical Cancer In young Adults".
Cervical cancer is the second most common cause of death from cancer in women worldwide and the number one cause in the developing world. The World Health Organization recently estimated that 510,000 women are diagnosed with cervical cancer and 288,000 women die from the disease every year. Cervical cancer is caused by infection with a virus called human papillomavirus (HPV). HPV infection is very common.
Approximately 75 per cent of women become infected with HPV at some time in their lives, usually soon after the onset of sexual activity. Although there are more than 100 different types of HPV, approximately 70 per cent of all cervical cancers are associated with infection with only two types, HPV 16 and HPV 18. These are the most important of the so-called 'high-risk', or oncogenic (cancer-causing) types of HPV.
GSK Biologicals has recently completed a pilot phase II study with the investigational cervical cancer vaccine, which is intended to offer protection against HPV 16 and HPV 18. The results were promising and the vaccine has progressed to phase III trials. Investigators at more than 90 sites in 14 countries around the world are currently seeking to enrol approximately 13,000 young women aged 15-25 years as volunteers to participate in this 4-year phase III study, which is aimed at evaluating the safety and efficacy of the new cervical cancer vaccine.