NEWTON, Mass., May 13, 2015 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that four abstracts describing the activity of selinexor (KPT-330), the company's lead drug candidate in development for hematological malignancies and solid tumors, have been selected for presentation at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29 to June 2, 2015 in Chicago. The abstracts, which represent both company and investigator-sponsored clinical studies, describe data related to selinexor, Karyopharm's first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound that inhibits exportin 1 (XPO1). Data to be presented include Phase 2 clinical updates in both gynecologic cancers and recurrent glioblastoma, as well as Phase 1b clinical data in advanced sarcomas and Phase 1 clinical data in Asian patients with advanced solid and hematological cancers.
"We are encouraged by the activity observed to date with selinexor in solid tumors, including the single-agent data to be presented at ASCO demonstrating durable anti-cancer activity and disease control in excess of three months across a broad range of heavily pretreated tumor-types including ovarian and endometrial cancers and advanced sarcomas," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We are also particularly excited about the clear demonstration of brain penetration and anti-tumor activity of single-agent selinexor in relapsed or refractory glioblastomas."
The following abstracts describe the potential role of single-agent selinexor across a variety of solid tumor cancers and the data will be further updated in the presentations at ASCO:
|Poster Title:||Phase I study of the safety and tolerability of the Exportin 1 (XPO1) inhibitor Selinexor (SXR) in Asian patients (pts) with advanced solid cancers.|
|Author:||Tan, National University Cancer Institute, Singapore (NCIS)|
|Session:||Developmental Therapeutics and Translational Research|
|Date/Time:||Saturday, May 30, 8:00 AM – 11:30 AM|
|Poster Title:||Preliminary phase II results of selinexor, an oral selective inhibitor of nuclear export in patients with heavily pretreated gynecological cancers.|
|Author:||Vergote, University Hospital Leuven|
|Date/Time:||Saturday, May 30, 1:15 PM – 4:45 PM|
|Poster Title:||A phase 1b study with selinexor, a first in class selective inhibitor of nuclear export (SINE) in patients with advanced sarcomas: An efficacy analysis|
|Author:||Gounder, Memorial Sloan Kettering Cancer Center|
|Date/Time:||Sunday, May 31, 8:00 AM – 11:30 AM|
|Poster Title:||A phase 2 study on efficacy, safety and intratumoral pharmacokinetics of oral selinexor (KPT-330) in patients with recurrent glioblastoma (GBM).|
|Session:||Central Nervous System Tumors|
|Date/Time:||Monday, June 1, 1:15 PM – 4:45 PM|
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, 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 750 patients have been treated with selinexor in company-sponsored Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Karyopharm has initiated three registration-directed clinical trials of selinexor, including one in older patients with acute myeloid leukemia (SOPRA), one in patients with Richter's transformation (SIRRT) and one in patients with diffuse large B-cell lymphoma (SADAL). Karyopharm plans to initiate a single-arm trial of selinexor in multiple myeloma in the first half of 2015 that is also intended to be registration-directed. In solid tumors, Karyopharm plans to initiate a registration-directed trial of selinexor to treat liposarcoma during the second half of 2015. 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 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 activity against a variety of different human cancers, SINE™ compounds have also shown biological activity in models of cancer, 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 PAK4 inhibitor, 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, 2015, which is on file with the Securities and Exchange Commission (SEC) as of May 11, 2015, 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.