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news.Gentium has announced that the Data Safety Monitoring Board has initiated the planned interim analysis for the company's Phase III trial of defibrotide to treat patients with severe veno-occlusive disease.
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The Data Safety Monitoring Board (DSMB) has conducted a safety analysis of defibrotide as part of the interim analysis and concluded that there are no safety concerns at this time. Additionally, the DSMB evaluated stratification between the prospective treatment and historical control arms and indicated that the groups appear to be balanced. The DSMB has asked the company to clarify and supplement certain trial data in order to complete the remainder of the interim analysis. After the DSMB indicates that it has concluded the interim analysis, the company will announce further results of the DSMB’s review.
Laura Ferro, chairman and CEO of Gentium, said: “Patient accrual in the trial continues, and 76 patients have been enrolled to date in the prospective treatment arm.”