Phase 2 Trial Of RP101 In Late-Stage Pancreatic Cancer Discontinued

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced the discontinuation of the investigational treatments under its randomized, placebo-controlled, double-blind Phase 2 trial that is evaluating RP101 -- a nucleoside analog known as BvdU -- for the treatment of late-stage pancreatic cancer. This decision followed the recommendation of the Data Safety Monitoring Committee (DSMC) with oversight responsibility for this clinical trial that was based upon the data reviewed at the most recent DSMC meeting. Further details will be reported when these data have been unblinded and reviewed by SciClone.


SciClone has notified the study investigators and appropriate regulatory authorities of the decision to discontinue the study. The company expects to conduct a detailed safety and efficacy analysis once the data are unblinded and will then evaluate what effect these data will have on any future RP101 development potential. At this time, SciClone anticipates that all remaining significant clinical trial expenses for this phase 2 trial will be incurred during 2009 and that this discontinuation will not adversely impact its previously provided financial guidance.


"We are disappointed with the discontinuation of this study and we will continue to evaluate future opportunities to bring new and effective treatments to these patients," said Friedhelm Blobel, PhD., President and Chief Executive Officer of SciClone. "We remain committed to our pipeline of promising compounds to treat cancer and infectious diseases including our ongoing phase 2 trials of SCV-07 in oral mucositis and HCV, our phase 3-ready trial of thymalfasin for Stage IV melanoma, and our planned human trial of thymalfasin for influenza H1N1 virus."


About RP101


RP101, also known as BvdU, is a nucleoside analog which has shown, in several preclinical and clinical studies, the potential to prevent the induction of resistance to chemotherapy by suppressing genes involved in development of that resistance and enhancing sensitivity to chemotherapy.


Source

SciClone