Stemline Therapeutics Initiates SL-401 Trial In AML Patients In First Complete Response With Minimal Residual Disease, The Second SL-401 Trial Initiated In 2H14

Stemline Therapeutics, Inc.

announced today the initiation of its second clinical trial for SL-401, a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of a wide range of hematologic cancers. This trial will enroll patients with acute myeloid leukemia (AML) who have achieved a complete response (CR) following their first course of induction chemotherapy, but display evidence of minimal residual disease (MRD) in their bone marrow and are at high risk for relapse. The study is designed to enroll at least 33 patients and will include a brief lead-in that will transition into a larger expansion stage. The trial will evaluate, among other parameters, SL-401's ability to eradicate evidence of MRD and increase CR duration. Participating sites include MD Anderson Cancer Center (Houston, TX), Duke University Medical Center (Durham, NC), and other major centers. This trial follows the first trial of SL-401, which is in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and relapsed/refractory AML and is actively accruing patients. Eric K. Rowinsky, M.D., Stemline's Chief Medical Officer and Head of Research and Development commented, "Despite frequent CRs achieved with first-line induction and consolidation chemotherapy in AML, the majority of patients will relapse suggesting that CRs are not really complete. Indeed, if we examine patient's bone marrow with sensitive methods we can find MRD that leads to relapse." He continued, "There is increasing evidence that MRD consists, in part, of leukemic cancer stem cells, which are resistant to the drugs that are currently used to treat AML. Since SL-401's target, the IL-3R, is highly expressed on AML, and particularly on leukemic cancer stem cells, SL-401 has the unique potential to eradicate these residual malignant cells and meaningfully increase the duration of CRs and survival."