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- Oral Presentation Describing Efficacy of Selinexor in Gynecological Cancers -
- Posters Highlighting Predictive Biomarkers of Selinexor Activity in Preclinical Models of Gynecological and Colorectal Cancers -
NEWTON, Mass., July 27, 2016 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that three abstracts have been selected for presentation at the European Society of Medical Oncology (ESMO) 2016 annual meeting held October 7-11, 2016 in Copenhagen, Denmark. One abstract describes updated data from the SIGN study, a Phase 2 clinical trial of selinexor (KPT-330), the Company's lead, novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound, for the treatment of gynecological cancers, and the other two abstracts feature preclinical data describing predictive markers of selinexor activity in gynecological and colorectal cancers.
“We look forward to sharing clinical data from the Phase 2 SIGN study in which the efficacy, safety and tolerability of single-agent selinexor is being evaluated in gynecological cancers with high unmet need, including metastatic ovarian, cervical and endometrial cancer,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.
The SIGN study is a Phase 2, open-label study evaluating the efficacy and safety of selinexor in patients with heavily pre-treated gynecological cancers, including cervical, ovarian and uterine carcinomas. The Phase 2 clinical data being presented at ESMO will expand upon the topline results previously reported at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting in which single-agent selinexor showed broad anti-tumor activity across heavily pretreated gynecological cancer populations and induced meaningful single-agent activity in patients with ovarian and endometrial cancers.
|Title:||Results of a Phase 2 Trial of Selinexor, an Oral Selective Inhibitor of Nuclear Export (SINE) in 114 Patients with Gynaecological Cancers|
|Author:||Vergote, Katholieke Universiteit Leuven, Belgium|
|Date/Time:||Friday, October 7, 2016 2:00-3:30 PM CET|
|Title:||Circulating Tumor Cell Number Predicts Time to Progression (TTP) in Patients with Heavily Pretreated Gynecological Cancers Treated with Selinexor (SEL)|
|Date/Time:||Saturday, October 8, 2016 1:00-2:00 PM CET|
|Title:||RAS/AKT Pathway Mutations as Predictive Biomarkers in Patients with Colorectal Cancer Treated with the Exportin 1 (XPO1) Inhibitor Selinexor (SEL) – Inhibition of Nuclear-Cytoplasmic Translocation of p27 as a Mechanism of Anti-Tumour Activity|
|Author:||Heong, National University Hospital, Singapore|
|Date/Time:||Monday, October 10, 2016 1:00-2:00 PM CET|
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. Over 1,500 patients have been treated with selinexor in company and investigator-sponsored Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Selinexor is being evaluated in several later-phase clinical trials, including one in older patients with acute myeloid leukemia (SOPRA), one in patients with diffuse large B-cell lymphoma (SADAL), one in patients with liposarcoma (SEAL) and a single-arm trial of selinexor and low-dose dexamethasone in patients with multiple myeloma (STORM). Additional Phase 1 and Phase 2 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 was founded by Dr. Sharon Shacham and is located in Newton, Massachusetts. For more information, please visit www.karyopharm.com.
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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on May 9, 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.
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