NEW YORK, Nov. 30, 2018 (GLOBE NEWSWIRE) — Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, highlighted four upcoming ELZONRIS™ (tagraxofusp; SL-401) presentations, including an oral presentation, at this weekend’s American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA.
Additionally, the Company will host an investor/analyst event on December 3, 2018, where it will provide updates on the progress of its pre-commercial activities, disease awareness campaign, and ongoing market expansion efforts. If interested in attending, please contact Investor Relations (investorrelations@stemline.com).
Details on the ASH presentations are below. Presentations will be available on the Stemline website, Scientific Presentations tab, after their delivery, as well as at our Stemline corporate booth (#205) at ASH 2018.
Saturday, December 1st – Poster Presentations
| Chronic Myelomonocytic Leukemia (CMML) | |||
| Title: | Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) | ||
| Presenter: | Mrinal Patnaik, MBBS; Mayo Clinic | ||
| Abstract: | 1821 | ||
| Session: | 637. Myelodysplastic Syndromes – Clinical Studies: Poster I | ||
| Date/Time: | Saturday, December 1, 2018 6:15 PM–8:15 PM PT | ||
| Location: | San Diego Convention Center, Hall GH | ||
| Myelofibrosis (MF) | |||
| Title: | Results from Ongoing Phase 1/2 Trial of Tagraxofusp (SL-401) in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis | ||
| Presenter: | Naveen Pemmaraju, MD; MD Anderson Cancer Center | ||
| Abstract: | 1773 | ||
| Session: | 634. Myeloproliferative Syndromes: Clinical: Poster I | ||
| Date/Time: | Saturday, December 1, 2018 6:15 PM–8:15 PM PT | ||
| Location: | San Diego Convention Center, Hall GH | ||
| Tagraxofusp + Hypomethylating Agents: Chronic Myelomonocytic Leukemia (CMML) | |||
| Title: | Evaluation of Combination Tagraxofusp (SL-401) and Hypomethylating Agent (HMA) Therapy for the Treatment of Chronic Myelomonocytic Leukemia (CMML) | ||
| Presenter: | Aishwarya Krishnan, Memorial Sloan Kettering Cancer Center | ||
| Abstract: | 1809 | ||
| Session: | 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster I | ||
| Date/Time: | Saturday, December 1, 2018 6:15 PM – 8:15 PM PT | ||
| Location: | San Diego Convention Center, Hall GH | ||
Monday, December 3rd – Oral Presentation
| BPDCN – Oral Presentation | |||
| Title: | Results of Pivotal Phase 2 Trial of Tagraxofusp (SL-401) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) | ||
| Presenter: | Naveen Pemmaraju, MD; MD Anderson Cancer Center | ||
| Abstract: | 765 | ||
| Session: | 616. Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: New Treatment Strategies | ||
| Date/Time: | Monday, December 3, 2018 3:15 PM PT | ||
| Location: | Manchester Grand Hyatt San Diego, Seaport Ballroom F | ||
About BPDCN
Please visit the BPDCN disease awareness booth (#205) at ASH 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a biopharmaceutical company focused on the development and potential commercialization of novel oncology therapeutics. Stemline is developing three clinical stage product candidates, ELZONRISTM (tagraxofusp; SL-401), SL-801, and SL-701. ELZONRIS is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a range of malignancies. ELZONRIS has successfully completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), for which it was granted breakthrough therapy designation (BTD). A Biologics License Application (BLA) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The European Medicines Agency (EMA) has granted ELZONRIS accelerated assessment for the upcoming marketing authorization application (MAA) submission, which is expected in the first quarter of 2019. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others. SL-801 is a novel oral small molecule reversible inhibitor of XPO1 that is currently in a Phase 1 trial of patients with advanced solid tumors; dose escalation is ongoing. SL-701, an immunotherapeutic, has completed a Phase 2 trial in patients with second-line glioblastoma; data and next steps for the program are being evaluated.
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 BLA submission to the FDA; the success and timing of our MAA submission to the EMA CHMP; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA, EMA, or other ex-U.S. national drug authority ultimately does not agree with our data, find our data supportive of approval, or approve any of our product candidates; the possibility that results of clinical trials are not predictive of safety and efficacy results of our product candidates in broader patient populations or of our products if approved; our plans to develop and commercialize our product candidates; the risk that estimates regarding the number of patients with the diseases that our product candidates may treat are inaccurate; our products not gaining acceptance among patients (and providers or third party payers) for certain indications (due to cost or otherwise); the adequacy of our pharmacovigilance and drug safety reporting processes; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; delays, interruptions, or failures in the manufacture and supply of our product candidates; the performance of third-party businesses, including, but not limited to, 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 SEC. 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
Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307
Email: investorrelations@stemline.com
