The randomized, placebo-controlled, double-blind Phase II clinical trial will be conducted at 55 sites throughout the US, Europe and South America. SciClone plans to enroll a total of 153 late-stage pancreatic cancer patients, randomized with two patients assigned to the treatment arm for each patient assigned to the control arm. Patients will receive either gemcitabine plus RP101 or gemcitabine alone for three weeks, followed by one week of rest, for each of six cycles. The primary endpoint is overall survival, with a secondary endpoint of progression-free survival. SciClone expects to complete enrollment of the 153 patients in the first half of 2009 and report data in the first half of 2010.
Friedhelm Blobel, president and CEO of SciClone Pharmaceuticals, said: “We are eager to evaluate RP101’s potential new mechanism of treating pancreatic cancer, by increasing sensitivity to chemotherapy while at the same time reducing chemoresistance.”