Stemline Therapeutics Announces Positive FDA Meeting and Agreement on Expedited Pathway to Full Approval of SL-401 in First-L...
January 05 2017 - 4:30PM
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today an
agreement with the U.S. Food and Drug Administration (FDA) on the
registration pathway for SL-401 in blastic plasmacytoid dendritic
cell neoplasm (BPDCN). To support the filing of a Biologics License
Application (BLA) for full approval in first-line BPDCN, Stemline
is currently enrolling an additional small cohort, planned for 8-12
first-line BPDCN patients, into its ongoing Phase 2 trial. To date,
approximately half of these new patients are enrolled into the
study, with full enrollment expected this quarter. Stemline intends
to file a BLA in 2H17, which is anticipated to undergo an
expedited review given SL-401’s Breakthrough Therapy
Designation. If successful, Stemline projects a commercial
launch of SL-401 in 2018.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer,
commented, “We are extremely pleased with the outcome of our
meeting with the FDA and the Agency’s continued guidance regarding
SL-401, which was granted Breakthrough Therapy Designation this
past August. The Agency has now provided us with a clear and
potentially rapid pathway to obtain full approval of SL-401 in
first-line BPDCN, as well as the possibility for review in the
relapsed/refractory setting. We are actively enrolling patients who
are to be included in the final cohort of the trial and are
targeting completion of enrollment this quarter.” Dr. Bergstein
continued, “In parallel, our operations and regulatory teams are
working hard to ensure a timely and comprehensive BLA filing,
including addressing additional data requests from the Agency,
while our commercial team is setting the stage, if approved, for a
successful launch of SL-401. Additionally, we continue to advance
SL-401 into other indications in an effort to provide benefit to
patients who are battling aggressive cancers.”
Conference Call and WebcastStemline
Therapeutics will host a conference call and audio webcast Friday,
January 6, 2017 at 8:00 AM ET. Interested participants and
investors may access the conference call by dialing 888-778-9052
(U.S./Canada) or 913-312-0850 (International) and referencing
conference ID: 9093286. An audio webcast can also be accessed via
the Investor Relations tab of the Stemline Therapeutics website at
http://ir.stemline.com.
About Blastic Plasmacytoid Dendritic Cell Neoplasm
(BPDCN) For more information on BPDCN, please visit
Stemline's patient and physician resource site:
www.bpdcninfo.com.
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 pivotal Phase 2 program 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; 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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