Transgene SA (Paris:TNG) (Euronext: TNG) today announced that the first patient has been dosed in a clinical trial with its immunotherapy product candidate TG1050 for the treatment of chronic hepatitis B virus (HBV) infection. This first-in-humans trial is an international, randomized, multi-center, double-blind, placebo-controlled safety and dose-finding study evaluating TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy.
The primary objectives of the Phase 1/1b study are to evaluate the safety and tolerability of TG1050 administered in single and multiple doses and to determine the dose and schedule of TG1050 administration to bring forward for further development. Secondary objectives include evaluating the antiviral activity of and immune responses to TG1050. Patients in the trial will continue to be treated with standard antiviral therapy. The Phase 1 part of this trial is planned to enroll up to 48 patients.
“We are pleased to advance another of our internally discovered and developed immunotherapy product candidates into the clinic, demonstrating the capabilities and productivity of our R&D organization,” said Philippe Archinard, Chairman and Chief Executive Officer. “With our programs, we seek to address major unmet medical needs in oncology and infectious diseases. More effective treatments are urgently needed for chronic hepatitis B, which can lead to severe liver disease, including cirrhosis and liver cancer.”
Read more...Labels: immunotherapy, TG1050, Transgene