MIGENIX completes first clinical study of celgosivir in chronic hepatitis C patients

A Phase IIa clinical study of celgosivir (MX-3253), an orally administered, a-glucosidase I inhibitor for the treatment of chronic hepatitis C virus (HCV) infections, developed by Vancouver-based MIGENIX, has confirmed the drug was well-tolerated with some evidence of anti-HCV activity.

This trial was designed to test the safety and tolerability of celgosivir in patients chronically infected with HCV and to evaluate viral load changes as monotherapy at different doses.

The current standard of care for chronic hepatitis C is pegylated interferon combined with ribavirin, which fails to provide a satisfactory outcome for the majority of patients infected with HCV genotype 1. It is estimated that successful therapy is achieved in less than 50% of patients. These drugs can also cause significant side effects that limit tolerance to the therapy.

Jim DeMesa, MD, president and ceo of MIGENIX said: 'This Phase IIa study in HCV patients with celgosivir as monotherapy, along with the safety and nonclinical synergy data generated to date, supports our combination therapy development strategy. A Phase IIb combination therapy study is expected to begin enrollment shortly and is intended to demonstrate that celgosivir can improve the current combination therapy for chronic HCV patients. It is encouraging that most investigators from the monotherapy trial are also participating in the combination trial.'