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Stemline Therapeutics Announces Five Presentations at the American Society of Hematology (ASH) Annual Meeting; SL-401 Poster Will Include Clinical Data From Lead-In and Ongoing Expansion Stages of BPDCN Pivotal Trial

NEW YORK, Nov. 5, 2015 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that it will present results from clinical and preclinical studies, including updated data from its ongoing SL-401 pivotal trial, at the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 5-8, 2015 at the Orange County Convention Center in Orlando, FL.

Five poster presentations, including one covering clinical data updates from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), will be featured. Three preclinical presentations will highlight data around SL-401's potential in additional indications as both a single agent as well as in combination. In addition, a poster demonstrating broad preclinical anti-cancer activity will be presented around SL-801, Stemline's novel oral XPO1 inhibitor being advanced toward the clinic across multiple hematologic and solid tumor indications.

Ivan Bergstein, M.D., Stemline's CEO, commented, "At the upcoming ASH meeting, we plan to share updated clinical data from the SL-401 pivotal trial in BPDCN. Data from the abstract demonstrate that SL-401 offers a manageable safety profile over multiple cycles with high response rates. We have also gained important insights into the dosing and administration schedule which has enabled us to improve the safety profile of SL-401 in BPDCN." Dr. Bergstein continued, "We also plan to present additional data on BPDCN patients from both the lead-in as well as initial expansion stage of the ongoing pivotal trial, including patients enrolled since abstract submission." Dr. Bergstein concluded, "In addition, we believe that SL-401's ability to induce responses quickly coupled with a manageable safety profile following multi-cycle administration may bode well not only for our single agent approach in relapsed/refractory BPDCN but also in future combination studies in larger indications, such as myeloma."

About SL-401 and SL-801

SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. Stemline is evaluating SL-401 in multiple clinical programs, including an ongoing pivotal trial in BPDCN, as well as trials in additional hematological cancers. SL-801 is a novel oral, small molecule reversible XPO1 inhibitor that is expected to enter clinical development in early 2016 for both solid and hematologic cancers.

Five abstracts were accepted for the 2015 ASH meeting, and the details on the presentations are listed below and available on the ASH conference website:

Lead-in Stage Results of a Pivotal Trial of SL-401, an Interleukin-3 Receptor (IL-3R) Targeting Biologic, in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or Acute Myeloid Leukemia (AML)
Lead Author: Marina Konopleva, MD, PhD
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

A Novel Agent SL-401 Triggers Anti-Myeloma Activity by Targeting Plasmacytoid Dendritic Cells: Implications for a Novel Immune-associated Mechanism
Lead Author: Arghya Ray, Ph.D.
The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patient-Derived Xenografts Are Faithful Genomic and Phenotypic Models of Primary Leukemia and Respond to the IL-3R targeting agent SL-401 In Vivo
Lead Author: Amanda Christie, B.A.
Department of Hematologic Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA

CD123 immunostaining in systemic mastocytosis: differential expression in disease subgroups and potential prognostic value
Lead Author: Animesh Pardanani, MBBS, Ph.D.
Department of Hematology, Mayo Clinic College of Medicine, Rochester, MN

SL-801, a novel, reversible inhibitor of Exportin-1 (XPO1) / Chromosome Region Maintenance-1 (CRM1) with broad and potent anti-cancer activity
Lead Author: Janice Chen, Ph.D.
Stemline Therapeutics, Inc., New York, NY

About Stemline Therapeutics

Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics that target cancer stem cells (CSCs) and tumor bulk. Stemline is developing two clinical stage product candidates, SL-401 and SL-701, and preclinical candidates that include SL-801. SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on CSCs and tumor bulk of a wide range of hematologic cancers. Several multicenter clinical trials with SL-401 are currently open in a variety of indications. Patients are currently being enrolled in the expansion stage of the SL-401 pivotal trial in relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). This follows recent completion of the lead-in stage of this trial that enrolled first-line and relapsed/refractory BPDCN and relapsed/refractory acute myeloid leukemia (AML) patients at escalating doses and confirmed the dose and schedule for the current expansion stage. A previous Phase 1/2 trial with SL-401 demonstrated major responses, including complete responses (CRs), in both first-line and relapsed/refractory BPDCN as well as relapsed/refractory AML (Frankel et al. Blood 124, 2014). Clinical studies with SL-401 are also open in additional malignancies including AML in CR with minimal residual disease (MRD) and several high-risk myeloproliferative neoplasms (MPN). SL-701, an immunotherapy designed to activate the immune system to attack tumors, is being developed in adult patients with second-line glioblastoma multiforme (GBM). SL-801, a novel oral small molecule reversible inhibitor of XPO1, is currently being advanced toward investigational new drug (IND) filing for clinical development in a variety of solid and hematologic 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 include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities; our plans to develop and commercialize our product candidates; 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.

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.