Phase 2 Study of Selinexor (KPT-330) Initiated by Karyopharm in Patients With Advanced Gynecologic Malignancies (SIGN Study)
April 24 2014 - 7:00AM
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage
pharmaceutical company focused on the discovery and development of
novel first-in-class drugs directed against nuclear transport
targets for the treatment of cancer and other major diseases, today
announced the initiation of a Phase 2 trial of its novel, oral
Selective Inhibitor of Nuclear Export (SINE) compound Selinexor
(KPT-330) in patients with advanced gynecologic malignancies
including cervical, ovarian and uterine carcinomas. The study,
referred to as the SIGN Study, is being led by Ignace Vergote, MD,
at the University Hospitals, Leuven, Belgium. SIGN is also open at
Rigshospitalet in Copenhagen, Aalborg University Hospital, Aalborg,
and Herlev Hospital, Herlev, all in Denmark.
In this Phase 2 study, patients will receive Selinexor at a dose
of 50mg/m2, twice a week. The primary goal of the study is to
determine the disease control rate assessed according to RECIST
criteria. The secondary goal of the study is to evaluate safety and
tolerability. Quality of life will also be evaluated. A full
description of the study is available at www.clinicaltrials.gov
(NCT02025985).
Dr. Vergote commented, "We are very excited to initiate this
study with Selinexor in patients with relapsed or refractory
carcinomas of the cervix, ovary or uterus. Selinexor has shown
intriguing activity in various solid tumor malignancies in the
ongoing Phase 1 studies, and we look forward to further evaluating
its activity in these difficult-to-treat patients who have limited
therapeutic options."
"This Phase 2 study in patients with advanced gynecologic
malignancies is designed to further characterize the single-agent
activity of Selinexor following signals in our ongoing Phase 1
study," said Dr. Sharon Shacham, founder, President and Chief
Scientific Officer of Karyopharm. "The activation of multiple tumor
suppressor proteins by Selinexor is a mechanism broadly applicable
across multiple cancer indications, and may be particularly suited
to the complex genetic lesions present in ovarian and other
gynecologic malignancies."
Selinexor is a covalent inhibitor of the nuclear export protein
XPO1 that enhances the accumulation and activation of multiple
tumor suppressor proteins in the nucleus. This leads to induction
of apoptosis in neoplastic cells, while largely sparing normal
cells. Preclinical results from several laboratories have shown
that Selinexor has single-agent activity against a variety of
ovarian cancer cell lines and murine xenografts across a variety of
genetic backgrounds. In an ongoing Phase 1 study in patients with a
variety of solid tumors, Selinexor has shown evidence of
anti-cancer activity across several tumor types, including patients
with gynecologic malignancies.
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective
Inhibitor of Nuclear Export (SINE) compound. Selinexor
functions by binding with the nuclear export protein XPO1 (also
called CRM1), leading to the accumulation of tumor suppressor
proteins in the cell nucleus, which subsequently reinitiates and
amplifies their tumor suppressor function. This is believed to lead
to the selective induction of apoptosis in cancer cells, while
largely sparing normal cells. Over 300 patients have been treated
with Selinexor in Phase 1 and Phase 2 trials in advanced
hematologic malignancies and solid tumors. Additional Phase 1
and Phase 2 studies are ongoing or currently planned and three
registration-directed clinical trials in hematological indications
are expected to begin enrollment during 2014. The latest 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
targets for the treatment of cancer and other major diseases. SINE
compounds have shown biological activity in models of cancer,
autoimmune disease, certain viruses, and wound-healing.
Karyopharm was founded by Dr. Sharon Shacham and is located in
Natick, Massachusetts.
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
therapeutic potential of and potential clinical development plans
for Karyopharm's drug candidates, including the timing of
initiation of certain trials and of the reporting of data from such
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 any of Karyopharm's SINE
compounds, including Selinexor (KPT-330), or any other drug
candidate that Karyopharm is developing 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 U.S. Food
and Drug Administration and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; 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 Annual
Report on Form 10-K for the year ended December 31, 2013, which is
on file with the Securities and Exchange Commission (SEC), 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.
CONTACT: Paul Brannelly
paul@karyopharm.com
508-975-4820
Jennifer McNealey
jmcnealey@annesassociates.com
917-392-3400
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