ELI LILLY STOPS BRAIN CANCER STUDY

After reviewing data gathered to date as part of a planned interim analysis, an external data monitoring committee (DMC) has recommended that Eli Lilly's STEERING trial be closed for enrollment. The global Phase III study was evaluating enzastaurin for the treatment of an aggressive and recurrent form of brain cancer.

Results of this planned interim analysis suggested that enzastaurin would not meet the primary endpoint of improvement in progression-free survival over an existing chemotherapy in this particular study. Lilly accepted the DMC recommendation and immediately contacted all study investigators to inform them of the decision.

"We are disappointed for patients suffering from recurrent glioblastoma, but we remain confident and committed to the development of enzastaurin," Richard Gaynor, vice president of cancer research for Eli Lilly, said. "Given the independently validated response rate of 22 percent in a Phase II trial, we plan to thoroughly review the data from this interim analysis and apply the insights learned to the glioblastoma program."

Enzastaurin is also being evaluated in a Phase III trial as a maintenance therapy for the treatment of non-Hodgkin's lymphoma as well as in several Phase II studies across a variety of more common tumor types including: breast, colon, lung, ovarian and prostate cancers. Enzastaurin is a potent multi-kinase inhibitor that targets selectively the PKCbeta and PI3/AKTsignaling pathways. By blocking these key pathways frequently over-expressed in a wide variety of cancers, enzastaurin suppresses tumor cell proliferation, induces tumor cell death and inhibits tumor-induced angiogenesis. The drug has orphan drug designation in Europe and the U.S. for the treatment of glioblastoma.