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news.SciClone Pharmaceuticals has reported topline results from the Phase 2b clinical trial of SCV-07 for the treatment of hepatitis C (HCV).
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The study was designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy and in combination with ribavirin in relapsed HCV patients.
The study results showed that SCV-07 was safe and well-tolerated at both administered doses.
Topline results, however, showed that SCV-07 did not meet the study’s primary efficacy endpoint, which was defined as a 2 log reduction in viral load from baseline level.
A secondary measure of efficacy, defined as a reduction in viral load of greater than 0.5 log from baseline level, was observed in 38.5%of the low-dose patients (5/13) and in 44.4% of the high-dose patients (8/18).
In addition, no patients in the low-dose group achieved greater than a 1 log reduction, while 3 of the high-dose patients achieved greater than a 1 log reduction in viral load.
SciClone president and CEO Friedhelm Blobel said due to the rapidly changing landscape of effective treatments which increase the complexity and risks of developing drugs in chronic HCV, the company has decided not to continue development in this indication.
"On another front, we continue to be excited about the potential for SCV-07 in the prevention of oral mucositis in patients with head and neck cancer and the initiation of our phase 2b study, which should begin by early 2011," Blobel said.
The Phase 2b multicentre, multi-dose, open-label study enrolled relapsed HCV patients, who were grouped into two cohorts of 20 patients each, in which each patient received SCV-07 at a dose of either 0.1 mg/kg or 1.0 mg/kg.