SciClone Pharmaceuticals, a biopharmaceutical company, has completed enrollment ahead of schedule in the company’s Phase II clinical trial for RP101 in patients with late-stage pancreatic cancer.
This study is a randomized, placebo-controlled, double-blind Phase II clinical trial conducted throughout the US, Europe, and South America. Patients assigned to the treatment arm receive RP101 plus gemcitabine, an approved pancreatic cancer treatment, while patients in the control arm receive gemcitabine alone. Treatment is delivered in cycles of three weeks followed by one week of rest, for at least six cycles of dosing.
The primary endpoint for the trial is overall survival, with progression-free survival as a secondary endpoint. SciClone expects to unblind the data from this trial in the first half of 2010.
Israel Rios, chief medical officer of SciClone, said: We have reached our enrollment goal of 153 patients at 50 study sites several weeks earlier than planned, an encouraging result.
As with our other drugs in development, thymalfasin and SCV-07, we are impressed with RP101’s excellent safety profile thus far. Given the promising data seen in the Phase I study, we believe that RP101 could become an important tool for the treatment of patients with unresectable pancreatic cancer.