Transgene presents additional Phase I data for TG4040 in Hepatitis C chronically infected patients

27-Apr-2009 - France

Transgene S.A. announced additional interim results from its ongoing Phase I clinical study of its therapeutic vaccine TG4040 (MVA-HCV) conducted in treatment-naive patients chronically infected with the hepatitis C Virus (HCV), and its decision to initiate a Phase II trial, planned for the beginning of 2010, in combination with standard of care (pegylated interferon alpha plus ribavirin).

A detailed analysis of these results was presented at an oral session of the EASL (European Association for the Study of Liver disease) annual meeting held in Copenhagen. The TG4040 Phase I data are as follows:

- 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 adverse event related to TG4040 were reported.

- Overall, 6 out of 15 patients experienced a decrease in viral load ranging from 0.5 to 1.4 log10 IU / mL from baseline.

- For the 2 patients showing the most significant viral load reduction (0.8 and 1.4 log10), this decrease coincided with an increase of vaccine-specific T-cell response (up to three times baseline levels). Furthermore, for one of those two patients, IFN-gamma-producing cells peaked one to two weeks after the third injection and remained detectable until the last follow-up analysis (six months), while during the same period the viral load remained significantly low. For those patients with no or minimal change in viral load, no immune responses to NS3 and NS4B viral antigens related to the vaccine, or to NS5A non-related to the vaccine were detectable by IFN-gamma ELISpot at any time during follow up.

https://www.bionity.com/en/news/100129/transgene-presents-additional-phase-i-data-for-tg4040-in-hepatitis-c-chronically-infected-patients.html