NEW YORK, May 18, 2018 (GLOBE NEWSWIRE) — Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, announced today that SL-401 will be the subject of three clinical presentations, including an oral presentation on the pivotal BPDCN program. Updated data from the ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) will also be presented. Presentations will be delivered at the upcoming 23rd Congress of the European Hematology Association (EHA), to be held from June 14-17, 2018, in Stockholm, Sweden. Abstracts are now available on the EHA congress website.
Details on the presentations are as follows:
| Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm | |
| • Abstract: | S116 |
| • Session: | Miscellaneous Treatments in AML |
| • Presenter: | Naveen Pemmaraju, MD; MD Anderson Cancer Center |
| • Oral Presentation: | Friday, June 15; 11:45 – 12:00 CEST (5:45 AM – 6:00 AM ET) |
| • Location: | Room A4 |
| Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis | |
| • Abstract: | PF618 |
| • Session: | Myeloproliferative neoplasms – Clinical |
| • Poster Presentation: | Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET) |
| • Location: | Poster Area |
| Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Relapsed/Refractory CMML | |
| • Abstract: | PF626 |
| • Session: | Myeloproliferative neoplasms – Clinical |
| • Poster Presentation: | Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET) |
| • Location: | Poster Area |
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, “We are honored to be showcasing, via oral presentation, the results of our SL-401 pivotal trial in BPDCN to a European audience via the EHA Congress. We believe this selection underscores SL-401’s robust clinical data and increased global awareness of BPDCN, a devastating malignancy of high unmet medical need. In the U.S., we remain on track to complete our rolling Biologics License Application (BLA) submission this quarter. In Europe, we anticipate feedback later this year from the European Medicines Agency (EMA) regarding the timing of a potential regulatory filing in the European Union. In addition, we and our investigators continue to report encouraging signs of clinical activity and safety in indications beyond BPDCN, including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), and we look forward to presenting updated data from these indications at the conference.”
Following each presentation at the conference, the data presented will be available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.
About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO 2018 and 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-801, and SL-701. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a range of malignancies. SL-401 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 rolling Biologics License Application (BLA) submission has been initiated. SL-401 is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and myeloma. 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
