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.
Study Extends Potential of Personalized Cell-based ImmunotherapiesNews
New methods developed for the study could be applied to devise personalized, cell-based immunotherapies for epithelial ovarian cancer or other types of tumorsREAD MORE
'Body-on-a-Chip' Could Advance Drug EvaluationNews
MIT engineers have developed new technology that could be used to evaluate new drugs and detect possible side effects before the drugs are tested in humans. Using a microfluidic platform that connects engineered tissues from up to 10 organs, the researchers can accurately replicate human organ interactions for weeks at a time.READ MORE
Hope for Hot Flushes: New Class of Menopause Drugs Reduces SeverityNews
A new class of experimental drugs reduces hot flushes in menopausal women by almost three-quarters in just three days. The new analysis, published in the journal Menopause, also revealed sleep and concentration significantly improved in the three-day window.