SAN DIEGO, March 15, 2011 /PRNewswire/ — iTherX, a
pharmaceutical company dedicated to discovering and developing a
new class of therapies for hepatitis C, today announced that it has
commenced patient recruitment in an open-label, proof-of-concept
Phase 1b study of its lead compound ITX-5061 in liver transplant
patients with hepatitis C virus infection (HCV). ITX-5061
represents a first-in-class compound that inhibits entry of the
hepatitis C virus into liver cells.
“ITX-5061 possesses a unique mechanism of action that prevents
the hepatitis C virus from entering liver cells and has
demonstrated potent preclinical antiviral activity against all HCV
genotypes.In addition, it has already demonstrated safety in more
than 280 subjects,” said Jeffrey McKelvy, PhD, MD, President and
Chief Executive Officer of iTherX. “We hope ITX-5061 will
significantly improve long-term transplant outcomes.”
The primary objective of the Phase 1b clinical trial will be to
assess the safety and tolerability of ITX-5061 in liver transplant
patients. The study will also assess HCV viral load for three
months after liver transplantation to determine if ITX-5061 has any
immediate and/or sustained impact on viral kinetics in treated
patients. Approximately 20 patients will be enrolled into one of
two cohorts: one group will receive supportive care only,
while the second cohort will also receive ITX-5061 at a150 mg daily
dose for seven days. The trial is being conducted at the
University of Birmingham, UK under the direction of David Mutimer,
MBBS, MD, FRACP, FRCP, Reader in Hepatology at Birmingham
University and Consultant Hepatologist to the Birmingham QE
Hospital Liver and Hepatobiliary Unit.
Preclinical studies have shown ITX-5061 to be a potent and
selective inhibitor of HCV entry into hepatocytes, capable of
preventing virus binding/fusion and cell to cell spread, suggesting
ITX-5061 may reduce re-infection rates followi
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