Stemline Therapeutics Announces New England Journal of Medicine Publication of ELZONRIS (tagraxofusp) Pivotal Study Results
April 25 2019 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, announced today
that the pivotal trial results of ELZONRIS™ (tagraxofusp), a
targeted therapy directed to CD123, in patients with blastic
plasmacytoid dendritic cell neoplasm (BPDCN) have been published in
the April 25 issue of the New England Journal of Medicine.
ELZONRIS (tagraxofusp-erzs) is approved by the U.S. Food and
Drug Administration (FDA) for the treatment of BPDCN in adults and
pediatric patients two years and older, and is commercially
available in the U.S.
Andrew Lane, M.D., Ph.D., Assistant Professor at Harvard Medical
School and Dana-Farber Cancer Institute and a co-lead author of the
manuscript, offered: “This publication by the New England Journal
of Medicine highlights the increasing recognition of BPDCN in the
medical community. As this landmark paper lays out, treatment with
tagraxofusp resulted in a high remission rate while maintaining a
predictable and a manageable safety profile, providing data
supporting the first-ever approved agent for treatment of this
aggressive malignancy. We thank our patients and collaborators for
the years of research that have led to a new era in the therapy of
BPDCN.”
Ivan Bergstein, M.D., Chief Executive Officer of Stemline,
commented “The publication of these pivotal data in the New England
Journal of Medicine underscores both the clinical benefit of
ELZONRIS for patients with BPDCN as well as the growing worldwide
awareness of this serious hematologic malignancy. We are very
thankful to the patients, their families, and the investigators who
helped make this breakthrough product a reality.”
About ELZONRIS™ ELZONRIS (tagraxofusp-erzs), a
CD123-directed cytotoxin, is approved by the U.S. Food and Drug
Administration (FDA) and commercially available in the U.S. for the
treatment of adult and pediatric patients, two years or older, with
blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full
prescribing information in the U.S., visit www.ELZONRIS.com. In
Europe, a marketing authorization application (MMA) is under review
by the European Medicines Agency (EMA). ELZONRIS is also being
evaluated in additional clinical trials in other indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and acute myeloid leukemia (AML).
About BPDCN BPDCN is an aggressive hematologic
malignancy with historically poor outcomes and an area of unmet
medical need. BPDCN typically presents in the bone marrow and/or
skin and may also involve lymph nodes and viscera. The BPDCN cell
of origin is the plasmacytoid dendritic cell (pDC) precursor. The
diagnosis of BPDCN is based on the immunophenotypic diagnostic
triad of CD123, CD4, and CD56, as well as other markers. For more
information, please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About CD123CD123 is a cell surface target
expressed on a wide range of myeloid tumors including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), certain
myeloproliferative neoplasms (MPNs) including chronic
myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute
myeloid leukemia (AML) (and potentially enriched in certain AML
subsets), myelodysplastic syndrome (MDS), and chronic myeloid
leukemia (CML). CD123 has also been reported on certain lymphoid
malignancies including multiple myeloma (MM), acute lymphoid
leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL),
and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has
been detected on some solid tumors as well as autoimmune disorders
including cutaneous lupus and scleroderma.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a commercial-stage biopharmaceutical company
focused on the development and commercialization of novel oncology
therapeutics. ELZONRIS™ (tagraxofusp), a targeted therapy directed
to CD123, is FDA-approved and commercially available in the U.S.
for the treatment of adult and pediatric patients, two years or
older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
In Europe, a marketing authorization application (MMA) is under
review by the European Medicines Agency (EMA). ELZONRIS is also
being evaluated in clinical trials in additional indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and acute myeloid leukemia (AML). Additional pipeline
candidates include: SL-701 (immunotherapeutic; Phase 2 in
glioblastoma patients completed), SL-801 (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-901 (novel kinase
inhibitor; prior abbreviated European Phase 1, IND-enabling studies
ongoing), and SL-1001 (novel RET kinase inhibitor, IND-enabling
studies pending). For more information, please visit the company’s
website at 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 of our MAA
submission to the EMA; 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, EMA, 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; the possibility that results of clinical trials are not
predictive of safety and efficacy results of our product candidates
in broader patient populations or of our products if approved; our
plans to develop and commercialize our product candidates,
including, but not limited to delays in arranging satisfactory
manufacturing capabilities and establishing commercial
infrastructure for ELZONRIS; product efficacy or safety concerns
resulting in product recalls or regulatory action; the risk that
estimates regarding the number of patients with the diseases that
our products and product candidates may treat are inaccurate;
inadequate market penetration of our products; our products not
gaining acceptance among patients (and providers or third party
payers) for certain indications (due to cost or otherwise); the
risk that third party payors (including governmental agencies) will
not reimburse for the use of ELZONRIS at acceptable rates or at
all; the company’s ability to produce, maintain or increase sales
of ELZONRIS; the company’s ability to develop and/or commercialize
ELZONRIS; the adequacy of our pharmacovigilance and drug safety
reporting processes; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our products and product candidates; delays, interruptions, or
failures in the manufacture and supply of our products and product
candidates; the performance of third-party businesses, including,
but not limited to, 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 SEC. 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 RelationsStemline
Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY
10022Tel: 646-502-2307Email: investorrelations@stemline.com
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