NATICK, MA, USA I July 31, 2013 I Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company focused on developing first-in-class nuclear transport modulators for the treatment of cancer and other major diseases, today announced the initiation of a Phase 1b clinical trial of its lead product candidate oral SINE Selinexor (KPT-330) in patients with advanced soft tissue or bone sarcomas. SINE compounds specifically and irreversibly inhibit the nuclear export protein Exportin 1 (XPO1 or CRM1), forcing the nuclear localization and activation of multiple tumor suppressor proteins. This XPO1 inhibition leads to selective killing of tumor cells, while sparing normal cells. Selinexor is the first oral SINE XPO1 antagonist to enter human clinical trials.
“The initiation of this Phase 1b trial of Selinexor is an important step forward in the clinical development of the drug candidate as we continue to make progress towards potential submission of regulatory filings related to its approval. It is crucial with oral drugs to determine the effect of food on absorption,” commented Karyopharm Founder, Chief Scientific Officer, and President of Research and Development, Sharon Shacham, Ph.D., M.B.A. “In addition, we anticipate that Selinexor tablets may be the formulation used in future studies so we look forward to data on that formulation.”
The Phase 1b trial is an open-label study of oral Selinexor in patients with several sarcoma types. The study is designed to assess the effects of food and formulation (capsules and tablets) on the absorption of oral Selinexor and to determine the anti-tumor activity, if any, of Selinexor in sarcoma patients whose disease has progressed on available therapies. The study will enroll up to 20 patients in the U.S. and Canada. The initiation of this study follows observations of preliminary evidence of anti-cancer activity of Selinexor in clinical trials, as reported at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study is being conducted in Toronto, Canada, and the United States. NPM Pharma Inc., (a Canadian company partly owned by Karyopharm) is overseeing the trial on behalf of Karyopharm.
More information about this Phase 1b trial is available at http://clinicaltrials.gov/show/NCT01896505
About Karyopharm
Karyopharm Therapeutics Inc. is a clinical-stage pharmaceutical company founded by Drs. Sharon Shacham and Michael Kauffman and has emerged as a leader in the new field of nuclear transport modulators. Karyopharm’s Selective Inhibitors of Nuclear Export (SINE) function by trapping multiple tumor suppressor proteins in the nucleus. Preliminary evidence of anti-tumor activity across multiple tumor types has been observed. Karyopharm’s lead SINE product candidate Selinexor (KPT-330) is in three Phase 1 clinical trials for advanced solid tumor and hematologic malignancies, including the Phase 1b Food-Effect clinical trial described above. The related SINE verdinexor (KPT-335) has completed a pivotal study as an oral treatment for dogs with Non-Hodgkin’s Lymphoma, one of the most common canine cancers. The Company is also testing SINEs in autoimmune, viral and dermatologic disorders. Karyopharm is located in Natick, Massachusetts.
SOURCE: Karyopharm
Post Views: 245
NATICK, MA, USA I July 31, 2013 I Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company focused on developing first-in-class nuclear transport modulators for the treatment of cancer and other major diseases, today announced the initiation of a Phase 1b clinical trial of its lead product candidate oral SINE Selinexor (KPT-330) in patients with advanced soft tissue or bone sarcomas. SINE compounds specifically and irreversibly inhibit the nuclear export protein Exportin 1 (XPO1 or CRM1), forcing the nuclear localization and activation of multiple tumor suppressor proteins. This XPO1 inhibition leads to selective killing of tumor cells, while sparing normal cells. Selinexor is the first oral SINE XPO1 antagonist to enter human clinical trials.
“The initiation of this Phase 1b trial of Selinexor is an important step forward in the clinical development of the drug candidate as we continue to make progress towards potential submission of regulatory filings related to its approval. It is crucial with oral drugs to determine the effect of food on absorption,” commented Karyopharm Founder, Chief Scientific Officer, and President of Research and Development, Sharon Shacham, Ph.D., M.B.A. “In addition, we anticipate that Selinexor tablets may be the formulation used in future studies so we look forward to data on that formulation.”
The Phase 1b trial is an open-label study of oral Selinexor in patients with several sarcoma types. The study is designed to assess the effects of food and formulation (capsules and tablets) on the absorption of oral Selinexor and to determine the anti-tumor activity, if any, of Selinexor in sarcoma patients whose disease has progressed on available therapies. The study will enroll up to 20 patients in the U.S. and Canada. The initiation of this study follows observations of preliminary evidence of anti-cancer activity of Selinexor in clinical trials, as reported at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study is being conducted in Toronto, Canada, and the United States. NPM Pharma Inc., (a Canadian company partly owned by Karyopharm) is overseeing the trial on behalf of Karyopharm.
More information about this Phase 1b trial is available at http://clinicaltrials.gov/show/NCT01896505
About Karyopharm
Karyopharm Therapeutics Inc. is a clinical-stage pharmaceutical company founded by Drs. Sharon Shacham and Michael Kauffman and has emerged as a leader in the new field of nuclear transport modulators. Karyopharm’s Selective Inhibitors of Nuclear Export (SINE) function by trapping multiple tumor suppressor proteins in the nucleus. Preliminary evidence of anti-tumor activity across multiple tumor types has been observed. Karyopharm’s lead SINE product candidate Selinexor (KPT-330) is in three Phase 1 clinical trials for advanced solid tumor and hematologic malignancies, including the Phase 1b Food-Effect clinical trial described above. The related SINE verdinexor (KPT-335) has completed a pivotal study as an oral treatment for dogs with Non-Hodgkin’s Lymphoma, one of the most common canine cancers. The Company is also testing SINEs in autoimmune, viral and dermatologic disorders. Karyopharm is located in Natick, Massachusetts.
SOURCE: Karyopharm
Post Views: 245
