"We are very encouraged by the responses and durability demonstrated to-date with selinexor in combination with low-dose dexamethasone in patients with relapsed and refractory multiple myeloma and look forward to continuing to evaluate selinexor in this patient population," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Despite the approvals of a variety of new agents, myeloma remains a fatal disease with nearly all patients relapsing after all available therapies. Selinexor has demonstrated promising durability and early signs of potential synergy with some of the approved anti-myeloma agents. We look forward to presenting the data from STORM in the near future."
This open-label, single-arm Phase 2 study of selinexor in combination with low-dose dexamethasone will evaluate the safety and efficacy of a fixed dose of selinexor (80 mg) plus low dose dexamethasone (20 mg). Each compound will be given orally twice weekly to approximately 80 patients with multiple myeloma with quad-refractory multiple myeloma. In addition, patients will have received alkylating agents and glucocorticoids, and their myeloma must be refractory to their most recent therapy. Overall response rate (ORR) is the primary endpoint of the study and this endpoint has served as the basis for accelerated approvals in multiple myeloma for other agents. STORM was designed based on data from Karyopharm's Phase 1 study of selinexor in combination with low dose dexamethasone in relapsed/refractory multiple myeloma.
As of December 1, 2014, Phase 1/2 data from ten heavily pretreated myeloma patients (median of seven prior therapies), nine of whom were evaluable for response, demonstrated a 67% ORR (partial response or better) and an 89% clinical benefit rate (minimal response or better). The overall median duration of response, measuring time from response to progression, is approximately seven months.
"We are very excited and honored to partner with Karyopharm to help bring life-saving treatments to multiple myeloma patients who are most in need," said
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. With the initiation of the STORM study, Karyopharm has now commenced four 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). In solid tumors, Karyopharm plans to initiate a registration-directed randomized trial of single agent 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 Multiple Myeloma
Multiple myeloma is the second most common hematological malignancy (after non-Hodgkin's lymphoma), representing 1% of all cancers and 2% of all cancer deaths. Despite the increased effectiveness of a variety of agents, including the availability of several newly approved therapies including immunomodulatory agents, proteasome inhibitors and histone deacetylase (HDAC) inhibitors, nearly all patients will eventually relapse with their disease becoming drug-resistant. The
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
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
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Source: Karyopharm Therapeutics
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