NEW YORK, May 19, 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) was selected for oral presentations at both the upcoming American Society of Clinical Oncology (ASCO) annual meeting being held in Chicago, IL and the 21st Congress of the European Hematology Association (EHA) being held in Copenhagen, Denmark. The full abstracts are now available on the respective conference websites.
| Details on the ASCO presentation are as follows: | |||
| Title: | Results from Phase 2 registration trial of SL-401 in patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Lead-in completed, Expansion stage ongoing | ||
| Presenter: | Naveen Pemmaraju, M.D., MD Anderson Cancer Center | ||
| Abstract No.: | 7006 | ||
| Session: | Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant | ||
| Date/Time: | Saturday, June 4, 2016; 5:00 – 5:12PM CT | ||
| Location: | Arie Crown Theater | ||
| 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 are honored that our trial results have been selected for oral presentation by both ASCO and the EHA. We believe this selection underscores the exciting clinical data we have witnessed with SL-401, and highlights the increased awareness of BPDCN, a devastating malignancy of high unmet medical need, across both the U.S. and Europe.”
Dr. Bergstein continued, “We remain very encouraged by SL-401’s continued strong performance to date. And we plan to provide updated enrollment, response rates and duration, as well as preliminary progression-free and overall survival data from the trial at the upcoming conferences.”
Dr. Bergstein concluded, “We look forward to continuing to advance SL-401 in an effort to provide patients this promising agent as rapidly as possible. Over the remainder of the year, we also plan to provide further clinical and regulatory updates from this study as well as our other clinical programs spanning multiple indications.”
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, with multiple complete responses (CRs). Patients in remission 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: Contact Investor Relations Stemline Therapeutics, Inc. 750 Lexington Avenue Eleventh Floor New York, NY 10022 Tel: 646-502-2307 Email: investorrelations@stemline.com
