Transgene Announces Promising Phase I Preliminary Results of Its HCV Therapeutic VaccinePreliminary analysis demonstrates a favourable safety profile and shows antiviral activity of TG4040 on chronically infected treatment-naïve patients
STRASBOURG, France, May 19th, 2008 – Transgene S.A. (Euronext Paris: FR0005175080) announces today the preliminary results of the ongoing Phase I trial for its therapeutic vaccine TG4040 (MVAHCV) conducted in patients chronically infected with the Hepatitis C Virus (HCV).
The trial, conducted in three sites in France, enrolled 15 treatment-naive patients chronically infected with the genotype 1 HCV. The patients received three weekly subcutaneous injections of TG4040.
Dosing was escalated from 106 pfu (three patients), to 107 pfu (three patients), and to 108 pfu (nine patients). Patients treated with the highest dose will also receive a boost injection of TG4040 at month 6.
Preliminary analysis performed on the 15 patients after the three weekly injections, but prior to receiving the boost injection, shows that TG4040 has a favourable safety profile across all doses. The most common side effects are mild to moderate injection site reactions. On April 30th, 2008 the Independent Safety Committee stated that it had no safety concerns and indicated that it is appropriate to continue the study.
Furthermore, six out of the 15 patients experienced a viral load reduction ranging from 0.5 to 1.4 log10, clearly indicating an effect of the vaccine on viral replication.
“These results, despite their preliminary and partial nature, are very encouraging and indicate that TG4040 is active against hepatitis C”, said Philippe Archinard, Chief Executive Officer of Transgene.
“These initial Phase I results clearly support pursuing and intensifying the clinical development of this novel therapeutic approach. We expect to present more detailed data, including boost vaccination results, by the fourth quarter of 2008.”
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Posted: May 2008