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Stemline Therapeutics, Inc. Announces Presentations of SL-401 Updated Clinical Trial Results in Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and SL-101 Preclinical Efficacy Data Against Hodgkin's Lymphoma at
Date:12/7/2012

NEW YORK, Dec. 7, 2012 /PRNewswire/ -- Stemline Therapeutics, Inc. today announced that two studies featuring SL-401 updated clinical trial results in acute myeloid leukemia (AML) and other hematologic malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), and SL-101 preclinical activity against Hodgkin's lymphoma have been selected for presentation at the upcoming 54th Annual Meeting of the American Society of Hematology (ASH) to be held in Atlanta, GA from December 8-11, 2012. Stemline and its collaborators from MD Anderson Cancer Center and Scott and White Memorial Hospital will present the posters.

The updated clinical trial results for SL-401, a novel biologic targeted therapy directed to the interleukin-3 receptor (IL-3R), demonstrated that the drug was well-tolerated at clinically active doses and showed single agent anti-tumor activity in heavily pretreated patients with AML, as well as in patients with high risk myelodysplastic syndrome (MDS) and relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). In particular, a single cycle of SL-401 demonstrated single agent activity in patients with relapsed or refractory AML, including two durable complete responses (CRs) of eight and >25 months duration, respectively, and multiple additional cases of leukemia blast reductions. An overall survival (OS) benefit was also notable among patients treated with only one cycle of SL-401 who were >/-3rd-line therapy for AML (n=35); the median OS was 3.6 months (95% CI: 2.3, 6.1 months), which is more than double the historical median OS results of 1.5 months for third-line AML patients treated with standard of care. Moreover, at therapeutically relevant doses defined as the MTD (16.6 µg/kg/day) or one or two dose levels below the MTD (9.4 or 12.5 µg/kg/day), the median OS among patients treated with only one cycle of SL-401 who were >/-3rd-line for AML (n = 16) was 5.6 months (95% CI: 2.5
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