On November 5, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported 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) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 5-8, 2015 at the Orange County Convention Center in Orlando, FL (Press release, Stemline Therapeutics, NOV 5, 2015, View Source [SID:1234507996]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) meeting, and the details on the presentations are listed below and available on the ASH (Free ASH Whitepaper) 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