Transgene's HCV vacc to enter Ph II in 2010

French drug developer Transgene SA reported positive data from the ongoing Phase I study of its therapeutic vaccine TG4040 conducted in  treatment-naive patients chronically infected with the hepatitis C  virus. On the back of the data, the firm plans to initiate a Phase II  trial, planned for the beginning of 2010, in combination with standard  of care.

A detailed analysis of these results was presented at an oral session of  the European Association for the Study of Liver Disease annual meeting  held in Copenhagen, Denmark. All studied doses were safe and  well-tolerated. The most frequent adverse events were minor to moderate  injection site reactions and influenza-like symptoms. No adverse event  leading to discontinuation or treatment modification and no serious side  effects related to TG4040 were reported.

Overall, six out of 15 patients experienced a decrease in viral load  ranging from 0.5 to 1.4 log10 IU / mL from baseline. For the two  subjects showing the most significant viral load reduction (0.8 and 1.4  log10), this decline coincided with an increase of vaccine-specific  T-cell response (up to three times baseline levels).