Transgene has announced positive results of the Phase II trial for its therapeutic vaccine candidate TG4001 (MVA-HPV-IL2) in the treatment of high-grade cervical intraepithelial neoplasia (CIN2/3), which is related to human papilloma virus type 16 (HPV16).
The trial, performed in nine centers in France, enrolled 21 women with HPV16 CIN2/3. The women ranged from 25 to 44 years of age with an average age of 34 years. The spontaneous regression rate in this population was estimated at approximately 20 percent. All patients received three injections of the therapeutic vaccine at the dose of 5.107 pfu administered subcutaneously. Colposcopy was performed every two months, together with cytology and virology testings, over a six month period following the first vaccine injection. TG4001 was shown to be safe, effective and well-tolerated in the majority of the study subjects.