Stemline Therapeutics Announces Oral Presentation of SL-701 Phase 2 Data in Second-Line Glioblastoma at the 22nd Annual Meeti...
November 16 2017 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
difficult to treat cancers, announced today that data from the
Phase 2 trial of SL-701 in patients with second-line glioblastoma
(GBM) were selected for oral presentation at the 22nd Annual
Meeting of the Society of Neuro-Oncology (SNO) being held November
16-19, 2017 in San Francisco, CA.
David A. Reardon, M.D., lead investigator of the study and
presenting author, commented, "SL-701 is exhibiting very
encouraging clinical activity, including long-term survivors, as
both a single agent and in combination with bevacizumab in a
relapsed GBM patient population. Notably, we are also witnessing
evidence of a robust target-specific CD8+ T-cell response tracking
with clinical benefit – a very exciting development and
confirmation of the drug’s immune mechanism of action. Given the
positive results seen here, combined with a high unmet medical need
in GBM, I will be working closely with Stemline to develop a
rational, registrational path forward for SL-701.”
Details on the presentation are as follows:
Title: |
|
Phase 2 Trial of
SL-701, a novel immunotherapy comprised of synthetic short peptides
against GBM targets IL-13Rα2, EphA2, and survivin, in adults with
second-line recurrent GBM |
Presenter: |
|
David Reardon, MD;
Dana-Farber Cancer Institute |
Abstract: |
|
ATIM-10 |
Date/Time: |
|
Sunday, November 19,
2017 – 10:45-10:55 AM PT |
|
|
|
A copy of the oral presentation will be available on the
Stemline website (www.stemline.com), under the Scientific
Presentations tab, following the SNO presentation.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a clinical stage biopharmaceutical company
developing novel therapeutics for difficult to treat cancers.
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), a cell surface receptor
expressed on a variety of malignancies including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive,
lethal malignancy of unmet medical need, with no approved
therapies. SL-401 was granted Breakthrough Therapy Designation
(BTD) by the U.S. Food and Drug Administration (FDA) for the
treatment of patients with BPDCN. A pivotal Phase 2 trial with
SL-401 in BPDCN has completed enrollment. An additional cohort is
currently enrolling BPDCN patients to ensure continued access to
SL-401. Additional Phase 1/2 trials with SL-401, including 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. Results presented at the European Society of Medical
Oncology (ESMO) Annual Congress in September 2017 included dose
escalation data of SL-801 through 6 dosing cohorts without dose
limiting toxicity. The ideal therapeutic dose of SL-801 has not yet
been determined and dose escalation/schedule optimization
continues. 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 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 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
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.
ContactInvestor RelationsStemline Therapeutics,
Inc.750 Lexington AvenueEleventh FloorNew York, NY 10022Tel:
646-502-2307Email: investorrelations@stemline.com
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