Stemline Therapeutics Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for SL-401
August 23 2016 - 7:30AM
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that the
U.S. Food and Drug Administration (FDA) has granted Breakthrough
Therapy Designation to SL-401, a targeted therapy directed to the
interleukin-3 receptor (CD123), for the treatment of blastic
plasmacytoid dendritic cell neoplasm (BPDCN).
The FDA’s Breakthrough Therapy Designation is intended to
expedite the development and review of a drug candidate for serious
or life-threatening conditions. The criteria for Breakthrough
Therapy Designation require clinical evidence demonstrating the
drug may offer substantial improvement on one or more clinically
significant endpoints versus existing therapies.
This Breakthrough Designation request was supported by efficacy
and safety data from the Phase 2 trial evaluating SL-401 in BPDCN
patients in both the first-line and relapsed/refractory
settings.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer,
commented, “We are very pleased that SL-401 has been granted
Breakthrough Therapy Designation for BPDCN by the FDA. We continue
to work closely with the agency in an effort to make this promising
agent available to all BPDCN patients as quickly as possible. Given
SL-401’s clinical activity in this CD123+ cancer, coupled with its
manageable, non-overlapping safety profile with other oncology
agents, we are also enthusiastic about the drug’s prospects in our
other enrolling clinical trials in additional CD123+ indications as
both a single agent and in combination. We expect to provide
further updates around our multiple SL-401 clinical programs later
this year.”
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a clinical stage biopharmaceutical company
developing novel oncology therapeutics. Stemline is developing
three clinical stage product candidates, SL-401, SL-701, and
SL-801. A Phase 2 potentially pivotal trial with SL-401, a targeted
therapy directed to the interleukin-3 receptor (CD123) present on a
wide range of hematologic cancers, is enrolling patients with
blastic plasmacytoid dendritic cell neoplasm (BPDCN) for which it
has received Breakthrough Designation from the U.S. Food and Drug
Administration (FDA). Data from this ongoing trial have
demonstrated high overall response rates (ORR), with multiple
complete responses (CRs). Patients are being followed for response
duration and outcomes, and new patients continue to enroll into the
study. In addition, ongoing Phase 2 trials with SL-401 are
currently enrolling patients with additional malignancies including
acute myeloid leukemia (AML) in remission with high risk for
relapse including minimal residual disease (MRD) and advanced, high
risk myeloproliferative neoplasms (MPN) of unmet medical need. A
Phase 1/2 trial in relapsed/refractory multiple myeloma with SL-401
in combination with standard therapies is also enrolling patients.
A Phase 2 trial with SL-701, an immunotherapy designed to activate
the immune system to attack tumors, is currently enrolling adult
patients with second-line glioblastoma multiforme (GBM). A Phase 1
trial with SL-801, a novel oral small molecule reversible inhibitor
of XPO1, is currently enrolling patients with advanced solid
tumors. For more information about Stemline Therapeutics, 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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