Stemline Therapeutics Presents SL-401 Lead-in Results from its Ongoing Phase 2 Trial in AML in Remission with MRD and Phase 2...
December 06 2016 - 11:48AM
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today the
presentation of SL-401 lead-in data from its ongoing Phase 2 trial
in acute myeloid leukemia (AML) in remission with minimal residual
disease (MRD) and ongoing Phase 2 trial in high-risk
myeloproliferative neoplasms (MPN) at the 2016 American Society of
Hematology (ASH) Annual Meeting. The AML/MRD results were delivered
via oral presentation by Andrew A. Lane, M.D., Ph.D., from the
Dana-Farber Cancer Institute (Boston, MA) and the MPN results were
presented by Mrinal S. Patnaik, M.D. from the Mayo Clinic
(Rochester, MN).
The full presentations are available on the Stemline website,
under the “Scientific Presentations” tab (see:
http://www.stemline.com/scientific-presentations.asp).
Safety Overview
- SL-401 was found to be safe and well tolerated, and side
effects were predictable and manageable. The lead-in dose
escalation stages of both Phase 2 studies (3 x 3 design) were
completed without dose limiting toxicity (DLT) and a maximum
tolerated dose (MTD) was not reached in either study (n=9 patients
in AML/MRD lead-in; n=9 patients in MPN lead-in). 12 ug/kg/day was
the highest tested dose in both studies and is currently the dose
level being used in the expansion stage of both studies.
Efficacy Overview
- AML/MRD - Early signs of efficacy in the AML
study included an MRD+ AML patient who sustained a decrease in MRD,
determined locally, treated at 12 ug/kg/day who then went on to
stem cell transplant. The expansion stage is currently enrolling
and, for uniformity, will utilize a central facility for MRD
analysis.
- MPN - Early signs of efficacy in the MPN study
including a patient with chronic myelomonocytic leukemia (CMML) who
sustained a bone marrow complete response (BMCR) and reduction in
spleen size. The expansion stage is currently enrolling CMML as
well as additional MPN types including myelofibrosis, mastocytosis,
and primary eosinophilic disorder.
Andrew A. Lane, M.D., Ph.D., lead author on the AML study,
commented, “Given the unacceptably high relapse rates seen in AML,
MRD has emerged as an important predictor of relapse with CD123 as
a key target for therapy. The preliminary results seen with SL-401
in this setting are promising. We look forward to enrolling
patients in the expansion stage of the trial as we continue to
optimize and refine methods to assess and follow MRD.”
Mrinal S. Patnaik, M.D., lead author on the MPN study, noted,
“The early data from the dose escalation portion of the trial
suggests SL-401 can be dosed safely in this patient population.
Additionally, we are observing encouraging signs of clinical
activity in several patients. We look forward to enrolling patients
in the expansion stage of the trial.”
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 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
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 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, 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
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