SuperGen Inc. announced that it has released and will discuss a preplanned interim analysis of the Dacogen (decitabine for injection) Phase III clinical study in patients with myelodysplastic syndrome (MDS).

The study protocol allowed for a predefined interim analysis after data from forty-five patients was available, which occurred in July, 2003. At that time, the interim analysis was discussed with the US FDA, and it was decided that release of the analysis would have jeopardized final study results. The trial is now in its final stages of analysis.

The interim analysis of the first 45 patients revealed that those receiving Dacogen had an increased time to acute myelogenous leukemia (AML) or death (median 105 days verses 92 days, P=0.036), which is the primary end point of the study. This analysis was based on data from 19 high-risk, 19 intermediate 2, and 8 intermediate 1 patients, as defined by the International Prognostic Scoring System (IPSS) that is used to classify MDS patients.

Data from 92 patients have been collected to date, allowing for a final analysis. However, the final analysis will not begin until all primary data points are verified and there can be no assurance that the final results will be consistence with the interim analysis. The company believes final study results will be available prior to the end of March. Recent discussions with the FDA have focused on the format and content of a planned submission of the clinical data.

"The interim analysis is based on limited preliminary data representing less than half of the currently available data and is not predictive of the final outcome of the trial. We are working diligently to complete final data analysis within this quarter," said Dr. James Manuso, CEO of SuperGen.