iTherX to Initiate Proof of Concept Clinical Study for First-in-Class Treatment for Hepatitis C
News Feb 06, 2009
iTherX Pharmaceuticals Inc has announced that it will initiate a Phase 2a clinical study of ITX5061, a potential therapy targeted at inhibiting the entry of the Hepatitis C virus (HCV) into liver cells.
The placebo-controlled, randomized trial is a parallel-group dose-response study of the ability of ITX5061 to reduce viral load in treatment-naive and previously treated patients with HCV infection, when ITX5061 is administered as a single agent.
“ITX5061 is an inhibitor of the entry of HCV into liver cells with a potency in the picomolar range, and is equally potent against both genotype 1 and genotype 2 viruses,” said Jeffrey McKelvy, Chief Executive Officer of iTherX.
“This molecule has exhibited a good safety profile in preclinical studies and in previous clinical studies involving over 250 subjects. Our Phase 2a study represents a first-in-class clinical efficacy study for a small molecule HCV entry inhibitor. We look forward to carrying out further clinical studies to demonstrate the value of ITX5061 in the treatment of this serious illness, which is poorly treated with current therapy,” McKelvy added.
The Phase 2a study will enroll approximately 40 patients at three centers in Europe. Primary endpoints for the study will be efficacy as measured by reduction in viral load. Safety and pharmacokinetics will also be assessed.
More than half of the drugs that have entered the market in Germany since then have emerged from these assessments without any proven added benefit. In a new publication using the first 216 assessments, researchers examine the reasons for this sobering result and develop suggestions for improvements in drug development.READ MORE
There are currently no drugs that stop or inhibit Alzheimer's disease. Despite drug trials showing plaque reduction in the brain, the patients' cognitive function did not improve. Would the results be different if it were possible to design studies that intervene much earlier on in the disease, before cognition is affected?READ MORE