Tuesday, March 11, 2014 by Proactive Investors
Biotron (ASX: BIT) has received ethics approval from Khon Kaen University for additional sites to carry out the ongoing phase 2 trial of its lead antiviral drug, BIT225, in patients co-infected with HIV and Hepatitis C virus (HCV).
The company now has approval to carry out the trial in Chiang Mai and an additional site in Bangkok.
These new sites in Chiang Mai and Bangkok are expected to initiate and then commence screening and enrolment over the next fortnight.
The study is a placebo controlled, double blind study of BIT225 in 60 patients infected with HCV genotypes 1 or 3.
Trial participants will receive 12 weeks of 200 mg BIT225 or placebo, dosed twice daily, in combination with current standard of care therapies - pegylated interferon alfa 2b (IFN) and ribavirin (RBV).
On completion of dosing with BIT225, they will remain on IFN/RBV for an additional 12 weeks (genotype 3) or 36 weeks (genotype 1).
The trial has been designed to generate safety and efficacy data on BIT225 over an extended treatment period.
Previous studies have shown BIT225 to be safe and well tolerated over a 28 day dosing period, with positive efficacy data in patients infected with HCV genotypes 1 and 3, as well as in HIV/HCV co-infected patients.