NEWTON, Mass., Nov. 5, 2015 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that 17 abstracts, including 5 oral presentations and 12 posters describing the activity of its oncology pipeline for the treatment of hematologic malignancies, have been selected for presentation at the 2015 American Society of Hematology (ASH) annual meeting taking place December 5-8, 2015 in Orlando, Florida. The abstracts, which represent both company and investigator-sponsored clinical and preclinical studies, describe data related to selinexor, Karyopharm's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE™) compound that inhibits exportin 1 (XPO1), as well as preclinical data on other pipeline programs, including a second generation SINE compound, KPT-8602, and PAK4 Allosteric Modulators (PAMs). Data from these abstracts will be updated in presentations and posters at ASH.
"The breadth of data to be presented on our oncology pipeline at ASH demonstrates the increasing level of effort we and our collaborators are deploying to leverage the mechanism for XPO1 inhibition across a wide range of hematologic malignancies," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Selinexor continues to demonstrate encouraging activity and tolerability in combination with other anti-cancer agents and our discovery efforts have generated new oncology pipeline candidates, including KPT-8602, a second generation SINE compound, and PAK4 Allosteric Modulators. We look forward to sharing this ample and growing body of data on our oncology pipeline at ASH."
Selinexor Clinical Presentations: | |
Title (oral): | Safety, Efficacy, and Determination of the Recommended Phase 2 Dose for the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) |
Author: | Christine Chen, Princess Margaret Cancer Center |
Abstract: | 258 |
Session: | 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: NHL – New Drugs |
Date/Time: | Sun, Dec 6, 12:00 - 1:30 pm |
Title (poster): | Phase 1 MMRC Trial of Selinexor, Carfilzomib (CFZ), and Dexamethasone (DEX) in Relapsed and Relapsed/Refractory Multiple Myeloma (RRMM) |
Author: | Andrzej J. Jakubowiak, The University of Chicago |
Abstract: | 4223 |
Session: | 653. Myeloma: Therapy, excluding Transplantation: Poster III |
Date/Time: | Mon, Dec 7, 6:00 - 8:00 pm |
Title (poster): | Selinexor, ARA-C and Idarubicin: An Effective and Tolerable Combination in Patients with Relapsed/Refractory AML: A Multicenter Phase II Study |
Author: | Walter Fiedler, MD, University Medical Center Hamburg-Eppendorf, Germany |
Abstract: | 3789 |
Session: | 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III |
Date/Time: | Mon, Dec 7, 6:00 - 8:00 pm |
Title (poster): | Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination with Fludarabine and Cytarabine in Pediatric Patients with Relapsed or Refractory AML |
Author: | Jeffrey E Rubnitz, MD, St. Jude Children's Research Hospital |
Abstract: | 1345 |
Session: | 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I |
Date/Time: | Sat, Dec 5. 5:30 - 7:30 pm |
Selinexor and SINE Preclinical Presentations: | |
Title (oral): | Recurrent mutations of the exportin 1 gene (XPO1) in primary mediastinal B-cell lymphoma: a LYSA study |
Author: | Fabrice Jardin, MD-PhD, INSERM, France |
Abstract: | 129 |
Session: | 622. Non-Hodgkin's Lymphoma |
Date/Time: | Sat, Dec 5, 4:00 – 5:30 pm (4:30 pm) |
Title (oral): | The Gain of the Short Arm of Chromosome 2 (2p+) Induces XPO1 Overexpression and Drug Resistance in Chronic Lymphocytic Leukemia |
Author: | Adrien Cosson, INSERM, France |
Abstract: | 492 |
Session: | 641. CLL |
Date/Time: | Mon, Dec 7, 7:00 – 8:30 am (8:15 am) |
Title (poster): | Selective Inhibitors of Nuclear Export (SINE) Compounds Suppress both HIV Replication and AIDS Related Lymphoma |
Author: | Dirk Daelemans, Rega Institute for Medical Research, Belgium |
Abstract: | 2751 |
Session: | 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
Title (poster): | Selinexor Is an Effective Cancer Treatment in Hypoxic Conditions and Synergizes with Proteasome Inhibitors to Treat Drug Resistant Multiple Myeloma |
Author: | Barbara Muz, Washington University in Saint Louis School of Medicine |
Abstract: | 3017 |
Session: | 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
Title (poster): | Combination Therapy of Selinexor with Bortezomib or Carfilzomib Overcomes Drug Resistance to Proteasome Inhibitors (PI) in Human Multiple Myeloma |
Author: | Joel G. Turner, H. Lee Moffitt Cancer Center |
Abstract: | 3048 |
Session: | 653. Myeloma: Therapy, excluding Transplantation: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
Title (poster): | Development of a Pharmacodynamic Assay for XPO1 Occupancy Using Fluorescence Cross Correlation Spectroscopy (FCCS) |
Author: | Marsha L. Crochiere, Karyopharm Therapeutics |
Abstract: | 2487 |
Session: | 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
Title (poster): | Selinexor, a Selective Inhibitor of Nuclear Export (SINE) Compound, Shows Synergistic Anti-Tumor Activity in Combination with Dexamethasone Characterized by Specific Pattern of Gene Expression in Multiple Myeloma (MM) |
Author: | Trinayan Kashyap, Karyopharm Therapeutics |
Abstract: | 3683 |
Session: | 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster III |
Date/Time: | Mon, Dec 7, 6:00 - 8:00 pm |
Title (poster): | XPO1 (Exportin-1) Is a Major Regulator of Human Erythroid Differentiation. Potential Clinical Applications to Decrease Ineffective Erythropoiesis of Beta-Thalassemia |
Author: | Guillem Flavia, IMAGINE INSTITUTE, France |
Abstract: | 2368 |
Session: | 501. Hematopoietic Stem and Progenitor Biology: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
KPT-8602 Preclinical Presentations | |
Title (oral): | Nuclear Export Inhibitor KPT-8602 Is Highly Active against Leukemic Blasts and Leukemia-Initiating Cells in Patient-Derived Xenograft Models of AML |
Author: | Julia Etchin, PhD, Dana Farber Cancer Institute |
Abstract: | 326 |
Session: | 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Drugs |
Date/Time: | Sun, Dec 6, 4:30 - 6:00 pm (4:45pm) |
Title (oral): | Next Generation XPO1 Inhibitor Shows Improved Efficacy and In Vivo Tolerability in Hematologic Malignancies |
Author: | Zachary A. Hing, The Ohio State University |
Abstract: | 317 |
Session: | 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Novel Targets and Therapeutics |
Date/Time: | Sun, Dec 6, 4:30 - 6:00 pm (5:30pm) |
Title (poster): | Next Generation XPO1 Inhibitor KPT-8602 for the Treatment of Drug-Resistant Multiple Myeloma |
Author: | Joel G. Turner, H. Lee Moffitt Cancer Center and Research Institute |
Abstract: | 1818 |
Session: | 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I |
Date/Time: | Sat, Dec 5, 5:30 - 7:30 pm |
PAK4 Allosteric Modulators Preclinical Presentations | |
Title (poster): | In vitro and in vivo anti-leukemic effects of PAK4 Allosteric Modulators in Acute Myeloid Leukemia: Promising Results Justifying Further Development |
Author: | Shaneice Mitchell, The Ohio State University |
Abstract: | 2471 |
Session: | 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster II |
Date/Time: | Sun, Dec 6, 6:00 - 8:00 pm |
Title (poster): | Dissecting Signaling Network Responses to PAK4 Allosteric Modulators (PAMs) in Cell Subsets within Primary Human Acute Myeloid Leukemia Samples |
Author: | Paul Brent Ferrell Jr., MD, Vanderbilt University Medical Center |
Abstract: | 3686 |
Session: | 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster III |
Date/Time: | Mon, Dec 7, 6:00 - 8:00 pm |
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. Over 1,200 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 four later-phase clinical trials of selinexor, including one in older patients with acute myeloid leukemia (SOPRA), one in patients with Richter's transformation (SIRRT), one in patients with diffuse large B-cell lymphoma (SADAL) and a single-arm trial of selinexor and lose-dose dexamethasone in patients with multiple myeloma (STORM). In solid tumors, Karyopharm plans to initiate a randomized, placebo-controlled Phase 2/3 trial of selinexor to treat liposarcoma during the fourth quarter 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.
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) and KPT-8602, or any other drug candidate, including PAK4 Allosteric Modulators 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 June 30, 2015, which is on file with the Securities and Exchange Commission (SEC) as of August 10, 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.