Stemline Therapeutics Presents SL-801 Phase 1 Data at ESMO 2017
September 11 2017 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
difficult to treat cancers, announced the presentation of clinical
data from the ongoing SL-801 Phase 1 trial in patients with
advanced solid tumors. The data were presented at the European
Society of Medical Oncology (ESMO) Annual Congress 2017 in Madrid,
Spain.
A summary of the SL-801 Phase 1 trial presentation is as
follows:
- 24 patients with advanced solid tumors were enrolled.--
75% of patients were third-line or greater, and include
colorectal and other gastrointestinal tumors, breast, non-small
cell lung cancer, neuroendocrine, genitourinary, and other tumor
types.-- Six dose levels (5, 10, 20, 30, 35 and 40 mg/day
dosed orally on days 1-4 and days 8-11 of a 21 day cycle) have been
cleared.
- Manageable safety and tolerability profile.-- No dose
limiting toxicity (DLT) or maximum tolerated dose (MTD) has been
reached.-- Most common treatment related adverse events
(TRAEs) were grade 1-2, with no grade 4 or 5 events reported.
- Stable disease (SD) was achieved in 37.5% (9/24) of patients,
with up to 20% tumor shrinkage noted in some heavily pre-treated
patients.
- The ideal therapeutic dose of SL-801 has not yet been
determined, as dose escalation continues. The seventh dose cohort
(45 mg/day) is currently enrolling.
The full presentation is available on the Stemline website
(www.stemline.com), under the "Scientific Presentations" tab.
Ivan Bergstein, M.D., Stemline’s CEO, commented, “SL-801 has
demonstrated a manageable safety and tolerability profile thus far
in the trial. We are also encouraged by multiple cases of stable
disease in heavily pretreated solid tumor patients. We continue to
increase the dose of SL-801 and plan to provide further data
updates throughout next year. In conjunction with the anticipated
read-out this year of pivotal data from SL-401, our lead program,
in blastic plasmacytoid dendritic cell neoplasm (BPDCN), we view
SL-801’s promising early data as another key step toward our
objective of building a leading commercial stage biopharmaceutical
company with a robust and innovative pipeline.”
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a clinical stage biopharmaceutical company
developing novel therapeutics for difficult to treat cancers.
SL-401, our most advanced drug candidate, was granted Breakthrough
Therapy Designation (BTD) for the treatment of patients with
blastic plasmacytoid dendritic cell neoplasm (BPDCN). BPDCN is a
highly aggressive, lethal malignancy of unmet medical need, with no
approved therapies. SL-401 is a targeted therapy directed to the
interleukin-3 receptor (CD123), a cell surface receptor expressed
on BPDCN and a variety of other malignancies. A pivotal Phase 2
trial with SL-401 in BPDCN has completed enrollment in Stages 1, 2
and 3 of the trial. An additional cohort, Stage 4, is currently
enrolling BPDCN patients to ensure ongoing access to SL-401.
Additional Phase 1/2 trials with SL-401, as a single agent or in
combination with other agents, are ongoing in patients with other
malignancies including myeloproliferative neoplasms (MPN) (focused
on chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]),
acute myeloid leukemia (AML), and multiple myeloma. A Phase 1 trial
of SL-801, a novel oral small molecule reversible XPO1 inhibitor,
is enrolling patients with advanced solid tumors. A Phase 2 trial
of SL-701, an immunotherapeutic, has completed dosing of patients
with second-line glioblastoma and patients are being followed for
outcomes including survival.
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, 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 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
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
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