Stemline Therapeutics Provides Update on Clinical Programs
February 21 2017 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
oncology indications of unmet medical need, today provided an
update on its clinical programs.
SL-401
- Patient enrollment has continued to advance, without
interruption, in all SL-401 clinical trials across multiple
indications, including the Phase 2 pivotal trial in blastic
plasmacytoid dendritic cell neoplasm (BPDCN).
- Given the enrollment trends, the projected timeline for
completing enrollment in the final cohort (Stage 3) of the BPDCN
pivotal trial remains on track for this quarter.
SL-801
- Patients with advanced solid tumors are currently enrolling
into a Phase 1 dose escalation study involving six centers. Four
dosing cohorts have been completed, and enrollment in the fifth
cohort is ongoing. Further trial updates are expected later this
year.
SL-701
- In a Phase 2 trial, adult patients with second-line
glioblastoma received SL-701 alone or in combination with
bevacizumab. The trial has been completed, and patients are being
followed to assess survival. Further updates are expected later
this year.
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), is
enrolling patients with blastic plasmacytoid dendritic cell
neoplasm (BPDCN), an indication for which SL-401 has been granted
Breakthrough Therapy Designation (BTD). 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 with 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, is completed and patients are being followed for survival
with second-line glioblastoma.
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 including the risk that the FDA 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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