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2003 MAY 14 - (NewsRx.com & NewsRx.net) -- Xenova Group plc (NASDAQ: XNVA; London Stock Exchange: XEN) has announced the results of an open label, physician-sponsored Phase II "prime-boost" study, targeting the treatment of human papillomavirus (HPV) associated ano-genital intraepithelial neoplasia (AGIN).
The announcement, made at the British Society for Colposcopy & Cervical Pathology (BSCCP) meeting in Manchester on April 12, 2003, relates to a study carried out on 29 patients at three centers in the U.K. Early results indicate that a prime boost strategy, using a combination of Xenova's TA-CIN and TA-HPV candidate therapeutic vaccines, is both safe and well tolerated and has demonstrated clear clinical responses, even in women with longstanding disease.
Human papillomavirus (HPV) is a large family of small DNA viruses associated with a number of conditions ranging from skin warts and genital warts to cervical cancer. Infection with high risk types of HPV (such as HPV16 and HPV18) is strongly associated with ano-genital cancer and its precursor AGIN. These diseases are difficult to treat and have a high recurrence rate.
TA-HPV is an immunotherapeutic vaccine which is being developed for use alongside surgery in the treatment of cervical cancer and for the treatment of high-grade AGIN. TA-CIN is a recombinant fusion protein, designed as a treatment for women with cervical dysplasia. Preclinical studies, conducted by Xenova in conjunction with scientists at Leiden University Medical Centre, The Netherlands, demonstrated that use of TA-CIN together with TA-HPV, resulted in an immune response that was significantly greater than that observed with either product alone. The present trials were designed to evaluate results in women using TA-CIN and TA-HPV in a "prime-boost" combination.
In the reported study, 29 women with stable, non-cervical disease were recruited in three centers: St. Mary's Hospital, Manchester; Llandough Hospital, Cardiff; and Addenbrooke's Hospital, Cambridge. Three doses of TA-CIN were given intramuscularly, at four-weekly intervals, followed four weeks later by a single dose of TA-HPV by dermal scarification. Women have been followed up for 12 weeks following completion of the vaccination schedule. Safety, clinical, and immunological responses, and ...