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.