All Currently Enrolled Patients with Stable Disease or Better Can Continue Receiving Selinexor
Company Has Amended Investigator’s Brochure and Informed Consent Documents as Requested by FDA
Company Expects Timelines for Both Ongoing and Planned Studies to Remain Materially Unchanged
NEWTON, MA, USA I March 10, 2017 I Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that it has received written notice from the U.S. Food and Drug Administration (FDA) that its clinical trials for selinexor (KPT-330) have been placed on partial clinical hold. While the partial clinical hold remains in effect, patients with stable disease or better may remain on selinexor therapy. No new patients may be enrolled until the partial clinical hold is lifted.
The FDA has indicated that the partial clinical hold is due to incomplete information in the existing version of the investigator’s brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with selinexor. At the FDA’s request, Karyopharm has amended the IB and updated the informed consent documents accordingly and has submitted such documents to the FDA as requested. The partial clinical hold is not the result of any patient death or any new information regarding the safety profile of selinexor. To date, more than 1,900 patients have been treated with selinexor in clinical trials across a variety of hematological and solid tumor malignancies.
As of Friday, March 10, 2017, Karyopharm had provided all requested materials to the FDA believed to be required to lift the partial clinical hold. By regulation, the FDA has 30 days from receipt of Karyopharm’s submission to notify the company whether the partial clinical hold is lifted. Karyopharm is working diligently with the FDA to seek the release of the partial clinical hold and resume enrollment in its selinexor clinical trials as expeditiously as possible. Karyopharm believes that its previously disclosed enrollment rates and timelines for its ongoing trials will remain materially unchanged.
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. To date, over 1,900 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017. Additional Phase 1, Phase 2 and Phase 3 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. Additional 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, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
SOURCE: Karyopharm Therapeutics
Post Views: 200
All Currently Enrolled Patients with Stable Disease or Better Can Continue Receiving Selinexor
Company Has Amended Investigator’s Brochure and Informed Consent Documents as Requested by FDA
Company Expects Timelines for Both Ongoing and Planned Studies to Remain Materially Unchanged
NEWTON, MA, USA I March 10, 2017 I Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that it has received written notice from the U.S. Food and Drug Administration (FDA) that its clinical trials for selinexor (KPT-330) have been placed on partial clinical hold. While the partial clinical hold remains in effect, patients with stable disease or better may remain on selinexor therapy. No new patients may be enrolled until the partial clinical hold is lifted.
The FDA has indicated that the partial clinical hold is due to incomplete information in the existing version of the investigator’s brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with selinexor. At the FDA’s request, Karyopharm has amended the IB and updated the informed consent documents accordingly and has submitted such documents to the FDA as requested. The partial clinical hold is not the result of any patient death or any new information regarding the safety profile of selinexor. To date, more than 1,900 patients have been treated with selinexor in clinical trials across a variety of hematological and solid tumor malignancies.
As of Friday, March 10, 2017, Karyopharm had provided all requested materials to the FDA believed to be required to lift the partial clinical hold. By regulation, the FDA has 30 days from receipt of Karyopharm’s submission to notify the company whether the partial clinical hold is lifted. Karyopharm is working diligently with the FDA to seek the release of the partial clinical hold and resume enrollment in its selinexor clinical trials as expeditiously as possible. Karyopharm believes that its previously disclosed enrollment rates and timelines for its ongoing trials will remain materially unchanged.
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. To date, over 1,900 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017. Additional Phase 1, Phase 2 and Phase 3 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. Additional 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, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
SOURCE: Karyopharm Therapeutics
Post Views: 200
