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Last $11.42 USD
Change Today -0.08 / -0.70%
Volume 34.5K
STML On Other Exchanges
Symbol
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NASDAQ CM
Frankfurt
As of 8:10 PM 07/27/15 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

750 Lexington Avenue

Eleventh Floor

New York, NY 10022

United States

Phone: 646-502-2311

Fax: 646-389-0968

Stemline Therapeutics, Inc., a clinical stage biopharmaceutical company, focuses on discovering, acquiring, developing, and commercializing proprietary therapeutics that target cancer stem cells (CSCs) and tumor bulk. Product Candidates SL-401 SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on CSCs and tumor bulk of various hematologic cancers. In 2014, the company opened a corporate sponsored investigational new drug (IND) with the FDA (the U.S. Food and Drug Administration). Three multicenter clinical trials with SL-401 are open in various indications, such as blastic plasmacytoid dendritic cell neoplasm (BPDCN) and relapsed/refractory acute myeloid leukemia (AML), the BPDCN portion of which the company has designed to serve as a potential registration trial; AML patients in first complete remission (CR) with minimal residual disease; and four types of advanced high-risk myeloproliferative neoplasms, including systemic mastocytosis, advanced symptomatic hypereosinophilic disorder, myelofibrosis, and chronic myelomonocytic leukemia. Additional SL-401 studies are planned in other indications, including myeloma and certain other lymphomas and leukemias. SL-401 demonstrated single agent clinical efficacy, including durable CRs, in a multi-center investigator sponsored Phase 1/2 clinical trial of patients with advanced hematologic cancers. SL-701 SL-701 is an enhanced immunotherapy designed to direct the immune system to attack targets present on brain cancer. SL-701 is being developed as a single agent in adult patients with second-line glioblastoma multiforme (GBM). In 2014, the company opened a corporate sponsored IND with the FDA. The company has advanced SL-701 into a corporate sponsored trial in adult patients with recurrent GBM, following initial treatment with surgery, radiation, and chemotherapy. The company also plans to pursue a trial of SL-701 in pediatric patients with brainstem and non-brainstem high-grade glioma. In January 2015, SL-701 was awarded Orphan Drug designation from the FDA for the treatment of glioma. SL-801 The company plans to advance its preclinical pipeline of product candidates, such as SL-801. SL-801 is a structurally novel, oral, small molecule that reversibly inhibits XPO1 (Exportin-1), also known as Chromosome Region Maintenance-1, a nuclear transport protein. SL-801 has demonstrated preclinical activity in a range of solid and hematologic tumors in both in vitro and in vivo xenograft experiments. The company is conducting IND-enabling work to support entry into clinical trials. The company then plans to advance SL-801 into corporate sponsored Phase 1 disease-directed, proof-of-concept trials in both solid and hematologic cancers. SL-501 SL-501 is a rationally designed, next-generation IL-3R-targeted therapeutic. SL-501 is a variant of SL-401 that binds to the IL-3R with higher affinity and demonstrates enhanced cytotoxicity against hematologic cancer cells in both in vitro and in vivo xenograft experiments, including in AML and chronic myeloid leukemia. In addition, SL-501 possesses preclinical anti-tumor activity against Hodgkin’s and non-Hodgkin’s lymphoma. SL-501 is progressing through IND-enabling studies. Further, the company might choose to evaluate the utility of SL-501 in various autoimmune diseases, in which the IL-3R-expressing plasmacytoid dendritic cell (the precursor cell of BPDCN) plays a putative role, such as systemic lupus erythematosus, systemic sclerosis (scleroderma), psoriasis, and rheumatoid arthritis. License and Research Agreements The company has a research and license agreement with Scott and White Memorial Hospital (Temple, Texas) (Scott and White) for SL-401, its biologic targeted therapy directed to the IL-3R. Under the agreement, Scott and White has granted the company an exclusive, royalty-bearing, worldwide license under certain patent rights, know-how and materials to research, develop, make, have made, formulate, use, sell, offer to sell and import SL-401, and any products containing or comprising such compound in finished dosage pharmaceutical form, for the diagnosis, prophylax

 

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