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Phase II study results of vaccine combination released.

Vaccine Weekly

| May 14, 2003 | COPYRIGHT 2003 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

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 ...

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