SciClone Discontinues Phase 2 Trial For RP101
RP101, a nucleoside analog known as BvdU, for the treatment of late-stage pancreatic cancer
SciClone Pharmaceuticals has discontinued the investigational treatments under its randomised, placebo-controlled, double-blind phase 2 trial evaluating RP101. RP101 is a nucleoside analog known as BvdU, intended for the treatment of late-stage pancreatic cancer.
Reportedly, the 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.
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.
The company anticipates that all remaining significant clinical trial expenses for the phase 2 trial will be incurred during 2009, and that this discontinuation will not adversely impact its previously provided financial guidance.
Friedhelm Blobel, president and CEO of SciClone, said: "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.”
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