Zadaxin thymosin alpha 1 data

SCLN announced that it will file for approval in Taiwan based on data from a Phase III trial in Taiwan and a meta-analysis of other clinical data obtained with Zadaxin. In the Taiwan trial, the agent gave an overall response rate of 40 percent, which was not significant versus placebo.

A total of 158 patients were randomized in the Taiwan study to receive either six months of Zadaxin and 12 months follow-up, 12 months of the agent and six months follow-up, or control observation for 18 months. The dose was 1.6 mg twice weekly. End points were levels of hepatitis B virus DNA and hepatitis B e antigen undetectable at 18 months. ...