Transgene Initiates A Phase I Trial of its Therapeutic Vaccine Candidate TG4040
Transgene S.A. announced that the first patients have been enrolled in a Phase I trial of its therapeutic vaccine candidate TG4040 (MVA-HCV) for patients chronically infected with the hepatitis C Virus (HCV). The trial is part of a development programme supported by Lyonbiopole.
The trial, conducted in France, will enroll 15 chronically infected patients who have never received any therapy for their condition. The patients will receive one subcutaneous injection of TG4040 per week over a 3-week period. Dosing will be escalated from 10(6) pfu (3 patients), 10(7) pfu (3 patients), to 10(8) pfu (9 patients). The patients treated with the highest dose will receive a boost injection of TG4040 at Month 6. The trial's primary endpoint is safety and secondary endpoints are immunological response to the vaccination and effect on viral load.
Availability of safety data is planned by year end 2007 and virological and immunological response parameters by the third quarter of 2008.
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