June 9, 2003
Access Pharmaceuticals reported positive results from a phase III trial investigating OraDisc A, drug releasing patch for the treatment of canker sores. Results demonstrated a statistically significant enhancement in the primary clinical endpoint, complete healing by day five. The randomized, placebo controlled study enrolled 604 subjects who were divided into three groups. In total, 303 subjects were treated with OraDisc A, which contains the active ingredient amlexanox, 301 subjects received a placebo disc and 97 subjects received no treatment. The full statistical analysis of this study has not been completed. The company plans to file for approval in the U.S. and Europe in the coming months.
InterMune reported positive interim data from a phase IV trial investigating Infergen (interferon alfacon-1) for the treatment of chronic hepatitis C infection. Results demonstrated that more than half (52%) of the subjects have responded to the treatment. At week 8, an antiviral response in serum was observed in 20% (6/30) and 27% (8/30) of subjects treated with the daily dosing and induction dosing regimen, respectively. At week 24, an antiviral response was observed in 40% (10/25) and 52% (14/25). Both the daily dosing and induction dosing regimens were found safe and moderately well tolerated. Adverse events included myalgia, fatigue and headache. The randomized, open-label trial was conducted in 50 chronic hepatitis C subjects who were non-responders to prior combination therapy with pegylated interferon and ribavirin. The trial will continue with combination therapy for an additional 24 to 64 weeks. Results were reported at the Digestive Disease Week 2003 conference in Orlando, Florida.