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news.Exelixis has said that its licensee Helsinn Healthcare has discontinued enrollment of new patients in the becatecarin phase III clinical trial program in biliary tract tumors when it was found that chemotherapy was more effective.
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Helsinn reported that despite some evidence of becatecarin activity, preliminary analysis of the phase III data by an independent data monitoring committee indicated that the comparator agent 5-fluorouracil demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives for the trial.
Exelixis in-licensed becatecarin from Bristol-Myers Squibb in 2001 and subsequently out-licensed it to Helsinn in June 2005.
Becatecarin is a small molecule, anticancer compound for the treatment of hepatobiliary duct tumors, a rare and aggressive form of cancer with a high medical need and very limited survival. Becatecarin was granted orphan drug designation in the US and the European Union.