Encouraging early findings on Transgene HCV vacc

French biotechnology firm Transgene SA has reported positive preliminary results from an ongoing Phase I trial of its therapeutic vaccine TG4040 (MVA-HCV) conducted in patients chronically infected with the hepatitis C virus.

The trial, carried out in three sites in France, enrolled 15 treatment-naive patients chronically infected with genotype-1 HCV. They received three weekly subcutaneous injections of TG4040. Patients treated with the highest dose will also receive a boost injection of TG4040 at month six. Preliminary analysis performed on the 15 patients after the three weekly injections, but prior to receiving the boost injection, shows that TG4040 has a favorable safety profile across all doses. The most common side effects are mild-to-moderate injection site reactions, the firm noted, adding that 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 Transgene chief executive Philippe Archinard. "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," he added.