HELSINN TO DISCONTINUE STUDY OF EXELIXIS' CANCER DRUG
Exelixis announced that its licensee Helsinn Healthcare has discontinued enrollment of new patients in the becatecarin (XL119) Phase III clinical trial program in biliary tract tumors. Exelixis in-licensed becatecarin from Bristol-Myers Squibb in 2001 and subsequently out-licensed it to Helsinn in 2005.
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 (5-FU) demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives for the trial.
The trial was taking place at multiple centers in North America and Europe. The primary endpoint of the 600-patient trial was increased survival of patients with bile duct tumors treated with XL119 compared with the chemotherapy agents 5-FU and leucovorin.
Becatecarin is a small-molecule anticancer compound in development for the treatment of hepatobiliary duct tumors, a rare and aggressive form of cancer with very limited survival, according to Exelixis. Becatecarin has been granted orphan drug designation in the United States and the European Union.
Upcoming Events
-
21Oct