NEW YORK, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq: STML ) announced today that SL-401, a novel targeted therapeutic directed to CD123, will be featured in 7 presentations, including 3 oral presentations, at the 2016 American Society of Hematology (ASH) Annual Meeting and Exposition, to be held December 3-6, 2016 at the San Diego Convention Center in San Diego, CA. The full abstracts are now available on the ASH conference website.
Investigators will deliver an oral presentation on updated clinical data from the SL-401 Phase 2 trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). Additional presentations include early clinical data from ongoing SL-401 trials in patients with acute myeloid leukemia (AML) in remission with high relapse risk and minimal residual disease (MRD), high-risk myeloproliferative neoplasms (MPN), and relapsed/refractory multiple myeloma. Preclinical data of SL-401 against AML, myelodysplastic syndrome (MDS), and myeloma cancer stem cells, as well as SL-401 in combination with SL-801, a novel XPO1 inhibitor, against myeloma and other malignancies will be presented as well.
Ivan Bergstein, M.D., Stemline’s CEO, commented, “We are honored to be presenting a broad range of SL-401 studies, including three oral presentations, at this year’s ASH conference. SL-401 is rapidly becoming recognized by the community as not only an active anticancer agent, but also one with the potential versatility, due to its unique mechanism of action and manageable safety profile, to be utilized as single agent or in combination in a broad range of indications.” Dr. Bergstein concluded, “Importantly, our clinical data in BPDCN continue to strengthen with increasing patient numbers and exposure, and we look forward to providing a robust and detailed update on this potentially pivotal program at the upcoming conference.”
Details on the presentations are as follows:
| SL-401 - BPDCN (Clinical) - Oral Presentation | ||
| Title: | Results from Phase 2 Trial Ongoing Expansion Stage of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) | |
| Presenter: | Naveen Pemmaraju, MD; MD Anderson Cancer Center | |
| Abstract: | 342 | |
| Session: | 613. Acute Myeloid Leukemia: Clinical Studies: Optimizing Current AML Therapy | |
| Date/Time: | Sunday, December 4, 2016 10:45 AM PT | |
| Location: | Marriott Marquis San Diego Marina, Pacific Ballroom | |
| SL-401 - AML in CR with MRD (Clinical) - Oral Presentation | ||
| Title: | Results from Ongoing Phase 2 Trial of SL-401 As Consolidation Therapy in Patients with Acute Myeloid Leukemia (AML) in Remission with High Relapse Risk Including Minimal Residual Disease (MRD) | |
| Presenter: | Andrew Lane, MD, PhD; Dana-Farber Cancer Institute | |
| Abstract: | 215 | |
| Session: | 613. Acute Myeloid Leukemia: Clinical Studies: Innovations in Induction Therapy | |
| Date/Time: | Saturday, December 3, 2016 5:00 PM PT | |
| Location: | Marriott Marquis San Diego Marina, San Diego Ballroom AB | |
| SL-401 - Myeloproliferative neoplasms (Clinical) | ||
| Title: | Results from Ongoing Phase 2 Trial of SL-401 in Patients with Advanced, High-Risk Myeloproliferative Neoplasms Including Chronic Myelomonocytic Leukemia | |
| Presenter: | Mrinal Patnaik, MBBS; Mayo Clinic | |
| Abstract: | 4245 | |
| Session: | 634. Myeloproliferative Syndromes: Clinical: Poster III | |
| Date/Time: | Monday, December 5, 2016 6:00 PM - 8:00 PM PT | |
| Location: | San Diego Convention Center, Hall GH | |
| SL-401 – Multiple myeloma (Clinical) | ||
| Title: | Results from Ongoing Phase 1/2 Trial of SL-401 in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma | |
| Presenter: | Myo Htut, MD; City of Hope | |
| Abstract: | 5696 | |
| Date/Time: | Thursday, December 1, 2016 publication release | |
| Location: | Published online on ASH abstract website | |
| SL-401 - AML and MDS cancer stem cells - Oral Presentation | ||
| Title: | SL-401 Mediates Potent Cytotoxicity Against CD123+ AML and MDS with Excess Blasts and Demonstrates Therapeutic Benefit in PDX Model | |
| Presenter: | Rajeswaran Mani, PhD; Ohio State University | |
| Abstract: | 580 | |
| Session: | 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Targeting Leukemia-Initiating Cells | |
| Date/Time: | Monday, December 5, 2016 7:45 AM PT | |
| Location: | San Diego Convention Center, Room 24 | |
| SL-401 in combination with SL-801 – Multiple myeloma and other malignancies | ||
| Title: | SL-401, a Targeted Therapy Directed to the Interleukin-3 Receptor (CD123), and SL-801, a Reversible Inhibitor of Exportin-1 (XPO1), Display Synergistic Anti-Tumor Activity Against Hematologic Malignancies in Vitro | |
| Presenter: | Janice Chen, PhD; Stemline | |
| Abstract: | 4724 | |
| Session: | 802. Chemical Biology and Experimental Therapeutics: Poster III | |
| Date/Time: | Monday, December 5, 2016 6:00 PM - 8:00 PM PT | |
| Location: | San Diego Convention Center, Hall GH | |
| SL-401 - Multiple myeloma | ||
| Title: | SL-401, a Novel IL-3Rα/CD123–Directed Agent Targets Stem-like Cells in Multiple Myeloma | |
| Presenter: | Arghya Ray, PhD; Dana-Farber Cancer Institute | |
| Abstract: | 4463 | |
| Session: | 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster III | |
| Date/Time: | Monday, December 5, 2016 6:00 PM - 8:00 PM PT | |
| Location: | San Diego Convention Center, Hall GH | |
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. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a wide range of malignancies. SL-401 is being advanced through a potentially pivotal Phase 2 trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an indication for which SL-401 has been granted Breakthrough Therapy Designation (BTD) by the FDA. SL-401 has demonstrated high overall response rates (ORR), with multiple complete responses (CRs), in both first-line and relapsed refractory patients, and response-driven outcomes including treatment duration and frequency of bridge to transplant have been trending favorably. SL-401 is also being advanced through Phase 1/2 trials of patients with additional malignancies including acute myeloid leukemia (AML) in remission with minimal residual disease (MRD), high risk myeloproliferative neoplasms (MPN), and relapsed/refractory multiple myeloma (in combination with pomalidomide). SL-801 is a novel oral small molecule reversible inhibitor of XPO1 that has demonstrated broad in vivo and in vitro preclinical activity in a wide array of solid and hematologic malignancies. A Phase 1 trial with SL-801 is open and enrolling patients with advanced solid tumors, and a Phase 1 trial in hematologic malignancies is planned. SL-701 is an immunotherapy designed to activate the immune system to attack tumors. A Phase 2 trial with SL-701 in adult patients with second-line glioblastoma multiforme (GBM) is ongoing. For more information about Stemline Therapeutics, please 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 Investor Relations Stemline Therapeutics, Inc. 750 Lexington Avenue Eleventh Floor New York, NY 10022 Tel: 646-502-2307 Email: investorrelations@stemline.com
