Karyopharm Announces Partial Clinical Hold to Pause Enrollment in Selinexor Trials
11 March 2017 - 11:55AM
All Currently Enrolled Patients with Stable
Disease or Better Can Continue Receiving Selinexor
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage
pharmaceutical company, today announced that it has received
written notice from the U.S. Food and Drug Administration (FDA)
that its clinical trials for selinexor (KPT-330) have been placed
on partial clinical hold. While the partial clinical hold
remains in effect, patients with stable disease or better may
remain on selinexor therapy. No new patients may be enrolled
until the partial clinical hold is lifted.
The FDA has indicated that the partial clinical
hold is due to incomplete information in the existing version of
the investigator’s brochure (IB), including an incomplete list of
serious adverse events (SAEs) associated with selinexor. At the
FDA’s request, Karyopharm has amended the IB and updated the
informed consent documents accordingly and has submitted such
documents to the FDA as requested. The partial clinical hold
is not the result of any patient death or any new information
regarding the safety profile of selinexor. To date, more than
1,900 patients have been treated with selinexor in clinical trials
across a variety of hematological and solid tumor malignancies.
As of Friday, March 10, 2017, Karyopharm had
provided all requested materials to the FDA believed to be required
to lift the partial clinical hold. By regulation, the FDA has
30 days from receipt of Karyopharm’s submission to notify the
company whether the partial clinical hold is lifted. Karyopharm is
working diligently with the FDA to seek the release of the partial
clinical hold and resume enrollment in its selinexor clinical
trials as expeditiously as possible. Karyopharm believes that its
previously disclosed enrollment rates and timelines for its ongoing
trials will remain materially unchanged.
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral
Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor
functions by binding with and inhibiting the nuclear export protein
XPO1 (also called CRM1), leading to the accumulation of tumor
suppressor proteins in the cell nucleus. This reinitiates and
amplifies their tumor suppressor function and is believed to lead
to the selective induction of apoptosis in cancer cells, while
largely sparing normal cells. To date, over 1,900 patients have
been treated with selinexor and it is currently being evaluated in
several mid- and later-phase clinical trials across multiple cancer
indications, including in multiple myeloma in combination with
low-dose dexamethasone (STORM) and backbone therapies (STOMP), and
in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL),
among others. Karyopharm plans to initiate a pivotal randomized
Phase 3 study of selinexor in combination with bortezomib
(Velcade®) and low-dose dexamethasone (BOSTON) in patients with
multiple myeloma in early 2017. Additional Phase 1, Phase 2 and
Phase 3 studies are ongoing or currently planned, including
multiple studies in combination with one or more approved therapies
in a variety of tumor types to further inform the Company's
clinical development priorities for selinexor. Additional clinical
trial information for selinexor is available at
www.clinicaltrials.gov.
About Karyopharm
Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a
clinical-stage pharmaceutical company focused on the discovery and
development of novel first-in-class drugs directed against nuclear
transport and related targets for the treatment of cancer and other
major diseases. Karyopharm's SINE™ compounds function by binding
with and inhibiting the nuclear export protein XPO1 (or CRM1). In
addition to single-agent and combination activity against a variety
of human cancers, SINE™ compounds have also shown biological
activity in models of neurodegeneration, inflammation, autoimmune
disease, certain viruses and wound-healing. Karyopharm, which was
founded by Dr. Sharon Shacham, currently has several
investigational programs in clinical or preclinical development.
For more information, please visit www.karyopharm.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding the anticipated impact of the partial clinical hold,
timing of FDA review of Karyopharm’s response, Karyopharm’s plans
for obtaining the release of the partial clinical hold, therapeutic
potential of and potential clinical development plans for
Karyopharm's drug candidates, including the timing of initiation of
and enrollment in certain trials. Such statements are subject to
numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from the Company's
current expectations. For example, there can be no guarantee that
the FDA will release the partial clinical hold in a timely manner
or at all, any of Karyopharm's SINE™ compounds, including selinexor
(KPT-330), will successfully complete necessary preclinical and
clinical development phases or that development of any of
Karyopharm's drug candidates will continue. Further, there can be
no guarantee that any positive developments in Karyopharm's drug
candidate portfolio will result in stock price appreciation.
Management's expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks
and uncertainties relating to a number of other factors, including
the following: Karyopharm's results of clinical trials and
preclinical studies, including subsequent analysis of existing data
and new data received from ongoing and future studies; the content
and timing of decisions made by the FDA and other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies, including with respect to the need
for additional clinical studies; Karyopharm's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of drug candidates by Karyopharm's competitors for
diseases in which Karyopharm is currently developing its drug
candidates; and Karyopharm's ability to obtain, maintain and
enforce patent and other intellectual property protection for any
drug candidates it is developing. These and other risks are
described under the caption "Risk Factors" in Karyopharm's
Quarterly Report on Form 10-Q for the quarter ended September 30,
2016, which was filed with the Securities and Exchange Commission
(SEC) on November 7, 2016, and in other filings that Karyopharm may
make with the SEC in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Karyopharm expressly disclaims any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Velcade® is a registered trademark of Takeda
Pharmaceutical Company Limited
Justin Renz
(617) 658-0574
jrenz@karyopharm.com
Eliza Schleifstein
(917) 763-8106
eliza@argotpartners.com
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