Ovarian cancer drug trial to be completed ahead of schedule

Published: 18-Jul-2003

UK-based biotechnology company Antisoma has issued a revised projection for the completion date of the pivotal phase III SMART study of R1549 (formerly Pemtumomab) in ovarian cancer.


UK-based biotechnology company Antisoma has issued a revised projection for the completion date of the pivotal phase III SMART study of R1549 (formerly Pemtumomab) in ovarian cancer.

This is now expected to fall between December 2003 and February 2004, according to the trial's independent Data Safety Monitoring Committee (DSMC), rather than February-August 2004 as previously announced. R1549 is being codeveloped with Roche.

The DSMC has also carried out a scheduled interim analysis of survival data from the trial and its regular review of safety data, and says there are no unexpected safety concerns or other reasons why the SMART trial should not continue to its final end point.

'As the SMART study nears completion we are working closely with Roche to ensure that we are in the best possible position to file regulatory submissions in the US and Europe,' said Glyn Edwards, ceo of Antisoma.

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