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Second Phase II Clinical Trial Of MVA-HPV-IL2 Vaccine Initiated.(Brief Article)
2002 JAN 16 - (NewsRx.com & NewsRx.net) -- Transgene announced the initiation of a Phase II clinical trial of its immunotherapeutic MVA-HPV-IL2 vaccine candidate for the treatment of vulvar intraepithelial neoplasia (VIN3).
The trial will be conducted in France and will include up to 30 women with VIN3. VIN3 is the most severe of three different forms of vulvar intraepithelial neoplasia (VIN), a vulvar tissue disease. It is caused by changes in the cells of the tissue that allow them to grow abnormally. In a small number of cases, VIN can progress to invasive cancer of the vulva.
Current treatments are usually irritating to patients and relapse is frequent. Surgery is currently not used to treat VIN3 when the lesions are extensive.
The Phase II clinical trial will be conducted at two sites in France, Ambroise Pare Hospital in Boulogne, and Cochin Hospital in Paris, and will evaluate the efficacy of multiple subcutaneous injections. The trial will be placebo-controlled and the primary objective is to demonstrate clinical efficacy as measured by the elimination of lesions in at least half of the treated patients at six months.
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Source: HighBeam Research, Second Phase II Clinical Trial Of MVA-HPV-IL2 Vaccine...