SciClone Pharmaceuticals’ nucleoside analogue RP101 is the latest investigational compound to fall by the wayside at a relatively advanced stage in the rush for a stake in the fast-expanding oncology market.

The US-based company, which focuses on novel therapies for cancer and infectious diseases, said it had discontinued a randomised, placebo-controlled, double-blind Phase II trial of RP101 for the treatment of late-stage pancreatic cancer. The decision was made on the recommendation of the Data Safety Monitoring Committee (DCMC) overseeing the study.

SciClone did not provide any more information on its reasons for stopping the trial. Further details would be available when the data reviewed at the most recent DSMC meeting had been unblinded and reviewed, it noted.

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”, it stated.

As things stand, SciClone added, any remaining significant expenses for the Phase II trial are expected to occur during 2009, and the pull-out should not have an adverse impact on the company’s previously issued 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,” commented president and chief executive officer Dr Friedhelm Blobel.

“We remain committed to our pipeline of promising compounds to treat cancer and infectious diseases including our ongoing Phase II trials of SCV-07 in oral mucositis and HCV [hepatitis C virus], our Phase III-ready trial of thymalfasin [Zadaxin] for Stage IV melanoma, and our planned human trial of thymalfasin for influenza H1N1 virus.”

Rodman & Renshaw analyst Reni Benjamin remained upbeat, despite the damage to SciClone’s share price from the RP101 announcement. According to the Associated Press, Benjamin has maintained a ‘Market Outperform’ rating for SciClone, citing the company’s strong research and development pipeline and expectations of strong Zadaxin sales.

That drug is already sold in more than 30 countries for the treatment of hepatitis B and hepatitis C, as well as for certain cancers and as a vaccine adjuvant.