Gentium off after defibrotide update

Gentium (NASDAQ:GENT) was off $2.04 (28%) to $5.36 on Friday after the company provided an update late Thursday on independent DSMB reviews of two trials of defibrotide. Gentium said the DSMB had "concerns and questions" about data from an ongoing, historically controlled Phase III trial of defibrotide to treat severe veno-occlusive disease (VOD) in hematopoietic stem cell transplant patients. The company said the DSMB recommended that Gentium "obtain confirmation" of the criteria used to select the trial's historical controls and "the practical application of those criteria to guarantee that the historical patients match the patients in the prospective study arm." Top-line data for the trial are expected in 4Q08. ...