Stemline Therapeutics Announces Three SL-401 Clinical Presentations, Including an Oral Presentation, at the Upcoming EHA Cong...
May 18 2018 - 7:00AM
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 TherapeuticsStemline
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 StatementsSome 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.
ContactInvestor RelationsStemline Therapeutics,
Inc.750 Lexington AvenueEleventh FloorNew York, NY 10022Tel:
646-502-2307Email: investorrelations@stemline.com
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