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Stemline Therapeutics Offers Top-Line Results from Lead-In Stage of Ongoing BPDCN Pivotal Trial: Says SL-401 Showed Multi-Cycle Safety, Efficacy

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Stemline Therapeutics, Inc. (Nasdaq: STML) today announced top-line results from the lead-in stage of its ongoing SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). These results demonstrate an acceptable safety profile, with no cumulative side effects observed after multiple cycles of SL-401 administered at dose levels up to 12 ug/kg/day. Three out of five BPDCN patients treated at the 12 ug/kg/day dose achieved major responses to date, including complete responses (CRs). Stemline intends to continue to enroll BPDCN patients in this ongoing pivotal trial at the 12 ug/kg/day dose level.

The lead-in stage of the corporate-sponsored SL-401 pivotal trial in BPDCN was designed to establish the safety, tolerability and efficacy of multiple cycles of SL-401 administered at three escalating dose levels: 7, 9, and 12 ug/kg/day for up to 5 days, repeated every 3 weeks. The trial enrolled 15 patients with either BPDCN or acute myeloid leukemia (AML). Side effects were similar to those reported in an earlier physician-sponsored clinical study and included manifestations of capillary leak and transient liver function test elevations. Cumulative toxicity was not observed in patients receiving multiple cycles of SL-401, including ten patients who have received at least two cycles, four of whom have received at least five cycles. At the multi-cycle dose-schedule of 12 ug/kg/day, three out of five BPDCN patients achieved major responses to date, including CRs, and patients remain on study. Major responses were also seen at lower doses. Stemline anticipates reporting full results of the lead-in stage later this year.

Eric K. Rowinsky, M.D., Chief Medical Officer and Head of Research and Development, commented, "We are very pleased with the results observed with multiple cycles of SL-401 in the lead-in stage of our ongoing pivotal trial in BPDCN. We have witnessed a tolerable safety profile of SL-401 and, importantly, a lack of cumulative toxicity with multiple cycles. We have also observed antitumor activity, including CRs, with SL-401 in BPDCN patients." Dr. Rowinsky continued, "We are working diligently with investigators to rapidly advance the pivotal trial in an effort to register SL-401 in patients with BPDCN both in the United States and in Europe. These trial results also amplify our enthusiasm for SL-401 not only in BPDCN, but in other difficult to treat IL-3R+ malignancies."

 

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