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GEN News Highlights : Dec 14, 2010

Safety Concerns Lead Lilly to Suspend Phase III Melanoma Trial

Firm is continuing studies with Tasisulam in other cancers, evaluating different dosing.

Safety concerns have led Eli Lilly to suspend a global Phase III trial evaluating the anticancer compound tasisulam as second-line therapy for unresectable or metastic melanoma. The full clinical hold will remain in place while existing data is analyzed, although additional trials in a range of other tumor types will be allowed to continue.

Lilly says that clinical development includes trials evaluating tasisulam at a different dosing level, and so will be allowed to carry on unmodified, albeit with close monitoring of patient safety.

With respect to the suspended melanoma study, Lilly plans to review the available data to see how the study protocol or tasisulam dosing could potentially be altered to improve patient safety. The study has been comparing the efficacy, safety, and tolerability of the small molecule drug candidate with paclitaxel, in over 300 patients in 18 countries.