VILLA GUARDIA, Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT) announced today interim results from an independent Data Safety Monitoring Board (DSMB) review of the Company’s Phase 3 treatment trial of Defibrotide for Severe Veno-Occlusive Disease (VOD). The DSMB reported that in order for the study to be 80% powered to detect a p-value of .01, the necessary statistical hurdle under the current protocol for FDA approval, the sample size should be increased to 160 patients in the treatment arm and 80 patients in the historical control arm. The DSMB also noted that a sample size of 102 patients in the treatment arm and 51 patients in the historical control arm would be needed to achieve a p-value of .05. Furthermore, the DSMB indicated that the data presented thus far do not raise any safety concerns and did not recommend that the trial be stopped for futility.
