Stemline Therapeutics’ SL-401 Phase 2 BPDCN Trial Results to be Delivered Via Oral Presentation at the EHA Meeting this Weekend


NEW YORK, June 10, 2016 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that its SL-401 Phase 2 clinical data in blastic plasmacytoid dendritic cell neoplasm (BPDCN) will be the subject of an oral presentation this weekend at the 21st Congress of the European Hematology Association (EHA) being held in Copenhagen, Denmark.

Details on the EHA presentation are as follows:

Title:   Results from ongoing Phase 2 registration study of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Presenter:  Naveen Pemmaraju, M.D., MD Anderson Cancer Center
Abstract No.:  S812
Session:  Treatment in Specific AML Subgroups
Date/Time:   Sunday, June 12, 2016; 9:00 - 9:15 AM CET
Location:  Hall C13
   

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, “We believe the selection  by the EHA of the SL-401 clinical results in BPDCN for oral presentation, to be delivered this weekend, highlights SL-401’s significant clinical activity in BPDCN, a devastating malignancy of high unmet medical need. Awareness of BPDCN is increasing across both the U.S. and Europe, driven in part by the emergence of this targeted agent, its high level of activity, and a greater understanding of the BPDCN diagnostic criteria.”

Dr. Bergstein concluded, “Over the remainder of the year, we plan to continue to enroll first-line and relapsed/refractory patients in this ongoing trial and advance our ongoing interactions with the regulatory authorities. Our goal is to bring this promising agent to market as soon as possible.”

About BPDCN
For more information on BPDCN, visit Stemline’s newly launched patient and physician resource site: www.bpdcninfo.com.

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-701, and SL-801. A potentially pivotal Phase 2 trial with SL-401, a targeted therapy directed to the interleukin-3 receptor (IL-3R; CD123) present on a wide range of hematologic cancers, is currently enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Data from the initial stage of this ongoing trial demonstrated high overall response rates (ORR), with multiple complete responses (CRs). Patients are being followed for response duration and outcomes, and new patients continue to enroll into the study. In addition, ongoing Phase 1/2 trials with SL-401 are currently enrolling patients with additional malignancies including acute myeloid leukemia (AML) in remission with high risk for relapse and myeloproliferative neoplasms (MPN) of unmet medical need. A Phase 2 trial with SL-701, an immunotherapy designed to activate the immune system to attack tumors, is currently enrolling adult patients with second-line glioblastoma multiforme (GBM). SL-801, a novel oral small molecule reversible inhibitor of XPO1, is currently enrolling patients in a Phase 1 clinical trial in advanced solid tumors. 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 Data