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Stemline Therapeutics' Lead Clinical Candidate SL-401 Induces a Complete Response in a Patient with a Drug-Refractory Plasmacytoid Dendritic Cell Neoplasm
Date:11/8/2012

gratifying to observe a CR and negligible side effects following use of a new agent in patients with cancers, in which approved treatments are of little to no value," said Dr. Eric Rowinsky, Chief Medical Officer and Head of Research and Development at Stemline Therapeutics. "Since we believe the explanation for this prominent clinical response and lack of side effects is SL-401's specific targeting of IL-3R, which is overexpressed on BPDCN and other hematologic malignancies, Stemline will continue to evaluate and potentially register SL-401 in BPDCN."

BPDCN is a relatively uncommon hematologic cancer of plasmacytoid dendritic cells, which are specialized immune cells that circulate throughout the bloodstream, bone marrow, and many other organs. In BPDCN, the cancer cells typically reside and grow in the skin and bone marrow. Their growth in the bone marrow results in decreased blood cell counts, thereby causing serious infections, bleeding, and invariably death. Although BPDCN can be controlled for brief periods with standard chemotherapy that is used to treat other hematologic cancers, meaningful clinical responses are rare and such treatment often produces serious side effects. There are no therapies approved to treat BPDCN. BPDCN cells express high levels of IL-3R on their cell surface, which served as the rationale for treating the patient with SL-401, which specifically targets the IL-3R. SL-401 has also demonstrated clinical activity in other hematologic malignancies that overexpress IL-3R, including AML and myelodysplastic syndrome (MDS). Other malignancies in which high levels of the IL-3R are expressed include Hodgkin's and non-Hodgkin's lymphoma, chronic myeloid leukemia (CML), and multiple myeloma. Preclinical studies of SL-401 in these cancers have demonstrated favorable anticancer activity. SL-401 is currently being advanced into a registration-directed Phase 2b study in advanced stage AML.

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