Stemline Therapeutics Announces Completion of Enrollment in Stage 3 of the SL-401 Pivotal Trial in BPDCN
March 23 2017 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
oncology indications of unmet medical need, announced today that
enrollment of Stage 3 in the SL-401 pivotal trial in blastic
plasmacytoid dendritic cell neoplasm (BPDCN) has been completed.
The company also reviewed key milestones for the SL-401 program
over the coming year.
Completes Stage 3
EnrollmentStemline has completed enrollment of the Stage 3
cohort of the SL-401 pivotal trial in BPDCN. Stage 3 enrolled 13
first-line BPDCN patients; statistical analysis will be based on
evaluable first-line patients. The registration pathway was
previously agreed upon with the U.S. Food and Drug Administration
(FDA). Depending on the data from the trial, Stemline plans to use
the results generated to support the potential filing of a
Biologics License Application (BLA) for full approval in first-line
BPDCN, and is targeting possible BLA filing in the second half of
this year.
This multicenter, pivotal trial has enrolled 47
BPDCN patients at seven centers in the U.S. The 47 BPDCN patients
were comprised of 32 first-line patients (29 dosed at 12 ug/kg/day)
and 15 relapsed/refractory patients dosed at 12 ug/kg/day. Stemline
plans to provide a clinical update on patients enrolled in Stages 1
and 2 at a medical conference around mid-year, with top-line data
from Stage 3 expected in the second half of 2017. To ensure ongoing
patient access to SL-401, Stemline plans to continue to enroll both
first-line and relapsed/refractory BPDCN patients under the current
protocol.
SL-401 received Breakthrough Therapy Designation
(BTD) by the FDA in August 2016.
BLA Preparation and Pre-Commercial
Activities UnderwayStemline’s clinical, preclinical,
manufacturing, and regulatory teams are working toward a timely and
comprehensive potential BLA filing. Ongoing efforts include
compiling the necessary supportive data and assembling the BLA
modules, including clinical, clinical pharmacology, non-clinical,
and CMC (chemistry, manufacturing, and controls). In parallel, the
commercial team is working to define the BPDCN market landscape,
including factors related to patient flow, market access and
pricing considerations, all with an eye toward setting the stage
for a successful launch of SL-401, if approved.
"I am very proud of the entire Stemline team and
our clinical investigators, who helped to make this key milestone
possible," said Ivan Bergstein, M.D., Chief Executive Officer of
Stemline. Dr. Bergstein continued, "Completing enrollment in our
pivotal trial is an important step toward our goal of bringing to
market a novel treatment for patients suffering from BPDCN, a
devastating disease. We continue to focus on following patients,
data collection, and advancing our BLA-targeted efforts on all
fronts.”
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical
company developing novel therapeutics for oncology indications of
unmet medical need. A Phase 2 pivotal trial with SL-401, a targeted
therapy directed to the interleukin-3 receptor (CD123), has
completed enrollment of patients with blastic plasmacytoid
dendritic cell neoplasm (BPDCN) in the Stage 3 pivotal cohort, and
patients continue to be followed. SL-401 has been granted
Breakthrough Therapy Designation (BTD) for the treatment of BPDCN.
Additional Phase 2 trials with SL-401 are enrolling patients with
other malignancies including high-risk myeloproliferative neoplasms
(MPN) and acute myeloid leukemia (AML) in remission with minimal
residual disease (MRD). A Phase 1/2 trial of SL-401 in combination
with pomalidomide is enrolling patients with relapsed/refractory
multiple myeloma. A Phase 1 dose escalation trial is enrolling
patients with advanced tumors with SL-801, a novel oral small
molecule reversible inhibitor of XPO1. A Phase 2 trial with SL-701,
an immunotherapy designed to activate the immune system to attack
tumors, has completed dosing and patients with second-line
glioblastoma are being followed for 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 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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