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MGI Pharma, Inc. Summarizes Data Presented at the 2007 American,Society of Clinical Oncology (ASCO) Annual Meeting

65.1- (Infinity)) compared to 72.7 weeks (95% CI, 57.7-84.3) for patients who did not receive Gliadel. One- and 2- year survival rates were also increased with the addition of Gliadel (81% vs. 67% and 44% vs. 27%, respectively). A Cox proportional hazards model accounting for the effects of the Recursive Partitioning Analysis (RPA) class was performed, and the effect of Gliadel treatment on survival was found to approach significance (p less than 0.055). Adverse events were similar in patients treated with or without Gliadel and included thrombocytopenia, leukopenia, seizures, fatigue, and gastrointestinal.

Irofulven

Results of a Randomized Phase 2 Trial of Irofulven in Hormone Refractory Prostate Cancer (HRPC) Patients who Failed First-line Docetaxel Treatment

Updated results of a randomized, 3-arm phase 2 study of irofulven + prednisone +/- capecitabine compared to mitoxantrone + prednisone in patients with HRPC were presented in a poster discussion on Saturday, June 2, 2007. A total of 137 patients with documented resistance to first-line treatment with docetaxel were stratified by presence or absence of disease related pain at study entry and assigned to treatment in a 2:2:1 manner (i.e. 4/5 patients received an irofulven-containing regimen). Although the study was not designed for a statistical comparison of survival, there was a consistent trend toward increased survival in the irofulven arms vs. mitoxantrone over the entire study period and through last follow-up. The observed median overall survival was 10.6 months for patients treated with irofulven + prednisone, 9.4 months for irofulven + capecitabine + prednisone, and 7.3 months for mitoxantrone + prednisone. Similarly, patients with disease-related pain at baseline receiving irofulven + prednisone had a median survival of 8 months vs. 5.5 months for those patients receiving mitoxantrone + prednisone. PSA response was noted in 22% of patients receiving irofulven + capecitabine + predn
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