NEW YORK, Nov. 02, 2018 (GLOBE NEWSWIRE) — Stemline Therapeutics, Inc. (Nasdaq: STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that ELZONRIS™ (tagraxofusp; SL-401), a novel targeted therapeutic directed to CD123, will be featured in four presentations, including an oral presentation, at the 2018 American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 1-4, 2018 in San Diego, CA.
Additionally, the Company is hosting an investor/analyst event on December 3, 2018 and plans to provide updates on the progress of its pre-commercial activities, disease awareness campaign, and market expansion efforts.
Details on the ASH presentations are as follows:
| 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 |
| 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 |
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, “We are honored that ASH has selected the BPDCN pivotal results for oral presentation. This selection underscores the heightening awareness of the disease – BPDCN, the target – CD123, and the clinical impact of the drug candidate – ELZONRIS. In addition, our regulatory team continues to work diligently in an effort to make ELZONRIS available to patients as quickly as possible, and our commercial team continues to execute on our broad-based pre-launch initiatives. This includes the build-out of our sales, marketing and reimbursement teams as well as continuing to advance our disease awareness campaign. In parallel, we are excited to present updated clinical data from our ongoing clinical trials in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF). Based on these data, we are enthusiastic about our plans to implement pivotal trials, or cohorts, in these devastating malignancies.”
About BPDCN
Please visit the BPDCN disease awareness booth at ASH 2018 (#205) and the website: 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, 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 completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), for which it was granted breakthrough therapy designation (BTD). The pivotal trial met its primary endpoint, and a Biologics License Application (BLA) has been accepted for filing and granted Priority Review by the FDA. 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 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 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; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; 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 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
