Karyopharm Publishes Preclinical and Phase 1 Clinical Data for Selinexor in Ovarian Cancer in Clinical Cancer Research Public...
28 September 2016 - 9:30PM
- XPO1 Inhibition Significantly Reduced Tumor
Burden in Platinum Sensitive and Resistant Ovarian Cancer
Models-
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage
pharmaceutical company, today announced that preclinical and Phase
1 clinical data describing XPO1 inhibition with selinexor
(KPT-330), the Company’s lead, oral Selective Inhibitor of Nuclear
Export / SINE™ compound, in ovarian cancer models and in patients,
were published online in Clinical Cancer Research. The paper,
entitled “Inhibition of the Nuclear Export Receptor XPO1 as a
Therapeutic Target for Platinum Resistant Ovarian Cancer,”
discusses scientific results supporting selinexor’s potential as a
new therapeutic strategy for platinum resistant ovarian cancer.
Published data have shown that XPO1 mRNA
overexpression is correlated with decreased survival and platinum
resistance in human ovarian cancer. Inhibition of XPO1 with
Karyopharm’s SINE compounds decreased cell viability and
synergistically restored platinum sensitivity in preclinical
models. In addition, selinexor treatment, alone and in
combination with cisplatin, markedly decreased tumor growth and
prolonged survival in a platinum-resistant ovarian cancer in vivo
model. These results were further confirmed in a Phase 1
clinical trial, which evaluated single agent oral selinexor in
patients with late-stage, recurrent, and heavily pre-treated,
platinum resistant ovarian cancer. In this study, selinexor
had manageable toxicity and tumor growth was halted in three of
five evaluable patients, including one patient with a confirmed
partial response. These results lead to the Phase 2 clinical study
“SIGN” (Selinexor in Gynecologic Malignancies), with results to be
released in an oral presentation at the European Society of Medical
Oncology (ESMO) 2016 annual meeting in Copenhagen.
“Ovarian cancer mortality rates are high, with
chemoresistance representing the major cause of treatment failure.
These data are encouraging, not only because they demonstrate that
inhibition of XPO1 with selinexor significantly increased tumor
killing regardless of platinum sensitivity, but also because
selinexor can be given safely in this late-stage, heavily
pretreated and platinum-resistant disease setting,” said John A.
Martignetti, MD, PhD, Associate Professor, The Mount Sinai
Hospital, and co-lead author of the paper.
Sharon Shacham, PhD, MBA, President and Chief
Scientific Officer of Karyopharm commented, “These findings are
important because they provide insights into the potential value of
XPO1 as a therapeutic target in ovarian cancer. We look
forward to expanding on our growing body of selinexor clinical data
in early October when we report results from the Phase 2 SIGN study
in patients with gynecological malignancies, including ovarian
cancer, at the ESMO Meeting.”
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 1,700 patients have
been treated with selinexor, which is currently being evaluated in
several mid- and later-phase clinical trials across multiple cancer
indications, including multiple myeloma in combination with
low-dose dexamethasone (STORM) and backbone therapies (STOMP),
acute myeloid leukemia (SOPRA), 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. 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 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 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), 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, 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 June 30, 2016,
which was filed with the Securities and Exchange Commission (SEC)
on August 4, 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.
Contact:
Justin Renz
(617) 658-0574
jrenz@karyopharm.com
Gina Nugent
(617) 460-3579
nugentcomm@aol.com
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