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Press Release

Stemline Announces Four SL-401 Presentations at Upcoming ASH Meeting

Posted on: 01 Nov 17

NEW YORK, Nov. 01, 2017 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, announced today that SL-401, a novel targeted therapeutic directed to CD123, will be featured in four presentations at the 2017 American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 9-12, 2017 in Atlanta, GA. The full abstracts are now available on the ASH conference website.

Investigators will present updated clinical data from the SL-401 pivotal Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). Additional presentations include clinical data from other ongoing SL-401 Phase 1/2 trials in patients with myeloproliferative neoplasms (MPN) (chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]) and acute myeloid leukemia (AML) in complete remission (CR) with minimal residual disease (MRD). Also, selected for oral presentation, are preclinical results of SL-401 in combination with azacitidine in hematologic cancers, which form the basis of the ongoing investigator-sponsored Phase 1 trial of SL-401 and azacitidine in patients with high-risk myelodysplastic syndrome (MDS) or elderly AML.

Details on the presentations are as follows:

SL-401: BPDCN (Clinical)
Title:Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter:Naveen Pemmaraju, MD; MD Anderson Cancer Center

Session:613. Acute Myeloid Leukemia: Clinical Studies: Poster I
Date/Time:Saturday, December 9, 2017 5:30 PM–7:30 PM
Location:Georgia World Congress Center, Building A, Level 1, Hall A2
SL-401: AML in CR with MRD (Clinical)
Title:Results from Ongoing Phase 2 Trial of SL-401 As Consolidation Therapy in Patients with Acute Myeloid Leukemia (AML) in Remission with High Relapse Risk Including Minimal Residual Disease (MRD)
Presenter:Andrew Lane, MD, PhD; Dana-Farber Cancer Institute
Session:613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Date/Time:Sunday, December 10, 2017 6:00 PM–8:00 PM
Location:Georgia World Congress Center, Building A, Level 1, Hall A2
SL-401: Myeloproliferative neoplasms (Clinical)
Title:Results from Ongoing Phase 2 Trial of SL-401 in Patients with Myeloproliferative Neoplasms Including Chronic Myelomonocytic Leukemia and Primary Myelofibrosis
Presenter:Mrinal Patnaik, MBBS; Mayo Clinic
Session:634. Myeloproliferative Syndromes: Clinical: Poster II

Date/Time:Sunday, December 10, 2017 6:00 PM–8:00 PM
Location:Georgia World Congress Center, Building A, Level 1, Hall A2
SL-401 + Azacitidine: High risk MDS and elderly AML (Preclinical) - Oral Presentation
Title:Resistance to SL-401 in AML and BPDCN Is Associated with Loss of the Diphthamide Synthesis Pathway Enzyme DPH1 and Is Reversible By Azacitidine
Presenter:Andrew A. Lane, Dana-Farber Cancer Institute
Session:604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Novel Therapeutics and Mechanisms of Resistance in Myeloid Disease
Date/Time:Monday, December 11, 2017 5:30 PM
Location:Georgia World Congress Center, Building B, Level 2, B207-B208

Please visit and the BPDCN awareness booth (#3143) at ASH 2017.

About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. Stemline is developing three clinical stage product candidates: SL-401, SL-801, and SL-701. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123), a cell surface receptor expressed on a variety of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive, lethal malignancy of unmet medical need, with no approved therapies. SL-401 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment. An additional cohort is currently enrolling BPDCN patients to ensure continued access to SL-401. Additional Phase 1/2 trials with SL-401, including as a single agent or in combination with other agents, are ongoing in patients with other malignancies including myeloproliferative neoplasms (MPN) (focused on chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma. A Phase 1 trial of SL-801, a novel oral small molecule reversible XPO1 inhibitor, is enrolling patients with advanced solid tumors. Results presented at the European Society of Medical Oncology (ESMO) Annual Congress in September 2017 included dose escalation data of SL-801 through 6 dosing cohorts without dose limiting toxicity. The ideal therapeutic dose of SL-801 has not yet been determined and dose escalation/schedule optimization continues. A Phase 2 trial of SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma and patients are being followed for outcomes including survival.

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 include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA or other ex-U.S. national drug authority ultimately does not agree with our data, find our data supportive of approval, or approve any of our product candidates; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors 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.

Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307


Last updated on: 01/11/2017

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