NEW YORK, Dec. 22, 2015 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today the opening of its SL-801 Investigational New Drug (IND) application and initiation of a broad clinical development program in multiple cancer types. SL-801 is an oral, reversible, small molecule inhibitor of Exportin 1 (XPO1), a promising and clinically validated oncology target overexpressed by many solid and hematologic cancers. SL-801 has demonstrated robust anti-cancer activity in animal models of multiple solid and hematologic malignancies.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, stated, “We are pleased to have successfully advanced the SL-801 program quickly through IND opening. Our SL-801 development strategy builds upon current knowledge in the XPO1 space and is designed to evaluate the agent’s clinical potential across multiple cancer types early in the program.” Dr. Bergstein concluded, “The clinical debut of SL-801 serves to advance our pipeline and greatly strengthen the company’s clinical and commercial potential.”
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics. Stemline is developing three clinical stage product candidates, SL-401, SL-801, and SL-701. A pivotal trial with SL-401, a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on tumor bulk and cancer stem cells (CSCs) of a wide range of hematologic cancers, is underway and currently enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). At ASH 2015, data from the lead-in and initial expansion stage of this ongoing pivotal trial demonstrated that multiple consecutive cycles of SL-401 were tolerable and produced high overall response rates in BPDCN patients. Patients continue to be followed for overall response, progression free survival (PFS) and overall survival (OS), and new patients continue to accrue into the study. Clinical studies with SL-401 are also open in additional malignancies including acute myeloid leukemia (AML) in complete remission with minimal residual disease (MRD) and 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, has an open IND and is being advanced into clinical trials across multiple cancer types. 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.