- Presentations Include Clinical Data on Activity of Selinexor (KPT-330) in Diffuse Large B-cell Lymphoma and Acute Myeloid Leukemia -
- An Oral Presentation to Highlight the Durability of Responses to Single-Agent Selinexor in DLBCL and a Late-Breaking Poster to Describe Responses to Selinexor in Combination with Chemotherapy in AML -
NEWTON, Mass., May 21, 2015 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that two 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 20th Congress of the European Hematology Association (EHA) 2015 Annual Meeting taking place June 11 - 14, 2015 in Vienna, Austria. Presentations include an oral presentation describing updated survival data from an ongoing company-sponsored Phase 1b clinical trial of single-agent selinexor in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL) and a late-breaking poster describing preliminary Phase 2 results from an ongoing investigator-sponsored clinical trial of selinexor in combination with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML).
"We are excited by these promising data to be presented at EHA, which continue to demonstrate the vast potential of selinexor across hematologic malignancies," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "The long-term survival benefit demonstrated with selinexor in DLBCL and the preliminary data suggesting that selinexor can be combined with chemotherapy in relapsed/refractory AML provide further evidence of selinexor's broad and durable activity, both as a single agent and in combination therapy."
The following abstracts describe the potential role of selinexor, Karyopharm's first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound in DLBCL and advanced AML. These data will be further updated in the presentations at EHA:
- An oral presentation with updated data from an ongoing Phase 1 clinical trial demonstrating that objective responses achieved with selinexor in this trial are durable and correlate with improved overall survival and progression free survival compared with patients who achieved stable or progressive disease, suggesting that these responses are associated with clinical benefit.
Title: Patients with Heavily Pretreated Diffuse Large B-Cell Lymphoma (DLBCL) who Respond to Oral Selinexor Therapy Show Prolonged Survival: Updated Phase 1 Results
|Author:||Kuruvilla, Princess Margaret Hospital, Toronto, Canada|
|Session:||Optimization and innovation in treating aggressive lymphomas|
|Date/Time:||Saturday, June 13, 4:45 PM - 5:00 PM|
- A late-breaking poster presentation of preliminary data from an ongoing Phase 2 clinical trial demonstrating that selinexor in combination with standard doses of Ara-C and idarubicin is a potentially effective strategy for treating patients with AML that was relapsed or refractory after at least one line of chemotherapy, without unexpected toxicities. An overall response rate of 53% (eight) was achieved based on fifteen evaluable patients and 67% (six) of those patients went on to receive either stem cell transplant or donor lymphocyte infusion. This represents the first presentation of clinical results of selinexor in combination with chemotherapy.
Title: Preliminary Phase II Results of Ara-C And Idarubicin in Combination with Selective Inhibitor of Nuclear Export (Sine) Compound Selinexor (KPT-330) in Patients with Relapsed or Refractory AML
|Author:||Fiedler, Department of Internal Medicine II and Clinic (Oncology Center), University Medical Center Hamburg|
|Session:||Acute myeloid leukemia - Clinical 4|
|Date/Time:||Saturday, June 13, 5:15 PM - 6:45 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 900 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. Karyopharm has initiated three registration-directed clinical trials of single-agent 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.