3/6/2012 7:20:50 AM
SciClone Pharmaceuticals, Inc., a specialty pharmaceutical company, has announced the results from a pre-planned interim analysis of the phase II b trial of SCV-07 in patients with oral mucositis (OM) indicate that the trial would not meet the pre-specified efficacy endpoints. After conferring with the study's independent Data Monitoring Committee (DMC), the company has decided to discontinue development of SCV-07 in this indication. SciClone is notifying the FDA and study investigators of the trial's discontinuation. No additional patients will be enrolled in the trial. Dosing of subjects currently enrolled in the trial will be discontinued, but subjects will be followed per protocol for a full year.
comments powered by