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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

NEW YORK, Oct. 16, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) 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."

About SL-401

SL-401 is a novel targeted therapy directed to the interleukin-3 receptor (IL-3R), a target present on tumor bulk and cancer stem cells (CSCs) of multiple hematologic cancer indications. SL-401 has demonstrated clinical activity in several indications, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS), as well as preclinical activity in rare myeloproliferative disorders, multiple myeloma (MM), chronic myeloid leukemia (CML), and certain lymphoid leukemias and lymphomas.

About Stemline Therapeutics

Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics that target both cancer stem cells (CSCs) and tumor bulk. Stemline is currently developing two clinical stage product candidates, SL-401 and SL-701. SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R). A multicenter clinical trial with SL-401 is currently open and accruing patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and advanced acute myeloid leukemia (AML). An additional clinical trial with SL-401 is currently open in patients with AML who are in first complete remission (CR) with minimal residual disease (MRD), which confers high rates of relapse. Stemline is also planning SL-401 trials in additional hematologic cancers including several uncommon, stem cell-derived myeloproliferative disorders. Previously, SL-401 demonstrated single-agent activity, including multiple durable complete responses (CRs), in a Phase 1/2 trial in several indications including BPDCN and relapsed/refractory AML. SL-701 is an enhanced immunotherapy designed to activate the immune system to attack tumors. A multicenter clinical trial with SL-701 is currently open and accruing adult patients with glioblastoma multiforme (GBM) in first recurrence. Previously, an earlier version of the therapy demonstrated clinical activity, including durable CRs and partial responses (PRs), in Phase 1/2 trials in adults and children with advanced brain cancers. For more information about Stemline Therapeutics, visit www.stemline.com.

Forward-Looking Statements

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially are identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

CONTACT: Investor Relations Stemline Therapeutics, Inc. 750 Lexington Avenue Eleventh Floor New York, NY 10022 Tel: 646-502-2307 Email: investorrelations@stemline.com

Source:Stemline Therapeutics, Inc.