On May 03, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that it has completed the initial dosing cohort in its SL-801 Phase 1 advanced solid tumor trial (Press release, Stemline Therapeutics, MAY 3, 2016, View Source [SID:1234511819]). The second cohort is currently open. SL-801 is a novel, oral, small molecule that reversibly inhibits the XPO1 (Exportin-1) nuclear transport protein, a clinically validated target active in a wide variety of cancer types.
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This Phase 1 dose escalation trial will enroll up to 50 patients with advanced solid tumors at multiple centers in the U.S. The trial is designed to evaluate safety, identify an optimal dosing regimen, and detect potential signals of efficacy in one or more cancer types.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, stated, "We are very pleased to have dosed the first patients in our SL-801 program during the first quarter, in-line with our expectations, and recently cleared the first dosing cohort. We are continuing to enroll patients with a wide range of solid cancer types in this trial in order to identify specific indications with both sensitivity to the agent as well as viable registration pathways. We believe we can leverage the unique properties of this compound along with our knowledge of the XPO1 space to create significant value from the program early on."