NEW YORK, Dec. 4, 2015 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that SL-401 and SL-801 will be the subject of five poster presentations at the 2015 American Society of Hematology (ASH) Annual Meeting, being held December 5-8, 2015 at the Orange County Convention Center in Orlando, FL.
Investigators will present updated clinical data from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), as well as three additional presentations highlighting preclinical data supporting SL-401's clinical development in mastocytosis as a single agent and in multiple myeloma in combination with approved agents. SL-801 will be the subject of a presentation detailing its broad preclinical anti-cancer activity in both solid and hematologic cancers in anticipation of the start of clinical trials.
Ivan Bergstein, M.D., Stemline's Chief Executive Officer, commented, "On Monday evening, investigators will present initial efficacy and safety data from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in BPDCN. We are very pleased with the initial outcomes of the ongoing study. Our experience from the lead-in stage enabled us to develop a regimen with specific dosing parameters that, since implementation, has generated a therapeutic window with manageable safety and high levels of clinical activity."
Details on the presentations are listed below and abstracts are available on the ASH conference website. Additionally, all abstracts and posters will be available on the Stemline website soon after the presentations.
SL-401 Presentations
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
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM - 8:00 PM
Location: Orange County Convention Center, Hall A
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
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM - 8:00 PM
Location: Orange County Convention Center, Hall A
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patient-Derived Xenografts Are Faithful Genomic and Phenotypic Models of Primary Leukemia and Respond to the IL3 Receptor 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
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM - 8:00 PM
Location: Orange County Convention Center, Hall A
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
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM - 8:00 PM
Location: Orange County Convention Center, Hall A
SL-801 Presentations
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
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM - 8:00 PM
Location: Orange County Convention Center, Hall A
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. 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.