French drugmaker Transgene SA has reported positive results from a Phase II trial of its therapeutic vaccine candidate TG4001 (MVA-HPV-IL2) in the treatment of high-grade cervical intraepithelial neoplasia (CIN2/3), a condition which is related to the human papilloma virus, type 16 (HPV16).
In the Phase II trial, performed in nine centers across France, 21 women with the condition who were an average age of 34 years, received three subcutaneous injections of the vaccine at a dose of 5.107 plaque-forming units. Colposcopy was performed every two months, together with cytology and virology testings, over a six-month period following the first treatment injection.
The firm has stated that the agent enabled surgery to be avoided in nine out of 18 women who took part in the dose-ranging trial. According to the recommendations of the American Association of Cancer Research task force on the treatment and prevention of intra-epithelial neoplasia, obtaining a 50% regression rate in CIN 2/3 with a new treatment is clinically-meaningful.
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