Multiple Asian Countries Involved; Takeda’s Second Phase 3 Oncology Study in China
SINGAPORE, Singapore I January 22, 2014 I Takeda Development Center Shanghai (TDC Shanghai) and Takeda Development Center Asia, Pte Ltd (TDC Asia) today announced that the TOURMALINE-MM1 global Phase 3 study has commenced in Asia for Takeda’s oral proteasome inhibitor, ixazomib (development code:MLN9708), in relapsed and/or refractory multiple myeloma (MM). Countries participating in the study include Australia, China, Japan, New Zealand, Singapore and South Korea. This will be the second Phase 3 oncology study conducted by Takeda in China. The addition of Asian sites to TOURMALINE-MM1 global trial further demonstrates Takeda’s commitment to the region.
Ixazomib is an investigational oral, proteasome inhibitor, which is being studied in multiple myeloma and other malignancies. It is the first oral proteasome inhibitor to enter Phase 3 clinical trials. As an investigational oral proteasome inhibitor, it constitutes a unique approach to targeted therapy. Inhibition of the proteasome prevents the degradation of numerous regulatory proteins, affecting multiple signaling cascades within the cell, inducing apoptosis.
Three ixazomib global Phase 3 trials are ongoing:
— TOURMALINE-MM1, investigating ixazomib in combination with lenalidomide and dexamethasone in R/R MM;
— TOURMALINE-MM2, investigating ixazomib in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM who are not eligible for transplantation; and
— TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory light chain amyloidosis (AL).
In the trials, the administration schedule for ixazomib is for one capsule (fixed dose), administered once a week. For additional information on the ongoing Phase 3 studies, please visit http://www.tourmalinetrials.com.
The International Myeloma Foundation (IMF) defines MM as “a cancer of cells in the bone marrow that affects production of red cells, white cells and stem cells and can damage bone. It is growing in numbers and affecting increasingly younger people”[1]. Multiple myeloma is the second most common hematologic malignancy. Worldwide there are approximately 86,000 new cases and more than 63,000 deaths annually[2].
Takeda is committed to developing new therapies which respond to unmet medical needs of patients so as to achieve its mission, “We strive towards better health for people worldwide through leading innovation in medicine.”
Note:
[1] http://myeloma.org
[2] Nikolaus Becker, Epidemiology of Multiple Myeloma in T. Moehler and H. Goldschmidt (eds.), Multiple Myeloma, Vol. 183, 2011, XXIV, pp25-35
About Takeda Development Center Shanghai
Based in Shanghai, China, Takeda Development Center Shanghai (TDC Shanghai) resides within the Shanghai-based Takeda (China) Holdings Co., Ltd., which is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. As one of the five development hubs, TDC Shanghai conducts high quality clinical development activities within the Asian region, with a focus on China for General Medicine, and across Asia for Oncology with Millennium: The Takeda Oncology Company. To learn more about these Takeda companies, visit www.takeda.com.
About Takeda Development Center Asia, Pte. Ltd.
Headquartered in Singapore, Takeda Development Center Asia, Pte. Ltd. (TDC Asia) is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Fully integrated into the global development organisation, TDC Asia serves as a regional hub for non-oncology clinical development. TDC Asia seeks to bring innovative products to people through a pipeline that includes compounds in development for metabolic and cardiovascular diseases, respiratory and immunology, central nervous system diseases, and other therapeutic areas.
SOURCE: Takeda Pharmaceutical Co
Post Views: 37
Multiple Asian Countries Involved; Takeda’s Second Phase 3 Oncology Study in China
SINGAPORE, Singapore I January 22, 2014 I Takeda Development Center Shanghai (TDC Shanghai) and Takeda Development Center Asia, Pte Ltd (TDC Asia) today announced that the TOURMALINE-MM1 global Phase 3 study has commenced in Asia for Takeda’s oral proteasome inhibitor, ixazomib (development code:MLN9708), in relapsed and/or refractory multiple myeloma (MM). Countries participating in the study include Australia, China, Japan, New Zealand, Singapore and South Korea. This will be the second Phase 3 oncology study conducted by Takeda in China. The addition of Asian sites to TOURMALINE-MM1 global trial further demonstrates Takeda’s commitment to the region.
Ixazomib is an investigational oral, proteasome inhibitor, which is being studied in multiple myeloma and other malignancies. It is the first oral proteasome inhibitor to enter Phase 3 clinical trials. As an investigational oral proteasome inhibitor, it constitutes a unique approach to targeted therapy. Inhibition of the proteasome prevents the degradation of numerous regulatory proteins, affecting multiple signaling cascades within the cell, inducing apoptosis.
Three ixazomib global Phase 3 trials are ongoing:
— TOURMALINE-MM1, investigating ixazomib in combination with lenalidomide and dexamethasone in R/R MM;
— TOURMALINE-MM2, investigating ixazomib in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM who are not eligible for transplantation; and
— TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory light chain amyloidosis (AL).
In the trials, the administration schedule for ixazomib is for one capsule (fixed dose), administered once a week. For additional information on the ongoing Phase 3 studies, please visit http://www.tourmalinetrials.com.
The International Myeloma Foundation (IMF) defines MM as “a cancer of cells in the bone marrow that affects production of red cells, white cells and stem cells and can damage bone. It is growing in numbers and affecting increasingly younger people”[1]. Multiple myeloma is the second most common hematologic malignancy. Worldwide there are approximately 86,000 new cases and more than 63,000 deaths annually[2].
Takeda is committed to developing new therapies which respond to unmet medical needs of patients so as to achieve its mission, “We strive towards better health for people worldwide through leading innovation in medicine.”
Note:
[1] http://myeloma.org
[2] Nikolaus Becker, Epidemiology of Multiple Myeloma in T. Moehler and H. Goldschmidt (eds.), Multiple Myeloma, Vol. 183, 2011, XXIV, pp25-35
About Takeda Development Center Shanghai
Based in Shanghai, China, Takeda Development Center Shanghai (TDC Shanghai) resides within the Shanghai-based Takeda (China) Holdings Co., Ltd., which is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. As one of the five development hubs, TDC Shanghai conducts high quality clinical development activities within the Asian region, with a focus on China for General Medicine, and across Asia for Oncology with Millennium: The Takeda Oncology Company. To learn more about these Takeda companies, visit www.takeda.com.
About Takeda Development Center Asia, Pte. Ltd.
Headquartered in Singapore, Takeda Development Center Asia, Pte. Ltd. (TDC Asia) is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Fully integrated into the global development organisation, TDC Asia serves as a regional hub for non-oncology clinical development. TDC Asia seeks to bring innovative products to people through a pipeline that includes compounds in development for metabolic and cardiovascular diseases, respiratory and immunology, central nervous system diseases, and other therapeutic areas.
SOURCE: Takeda Pharmaceutical Co
Post Views: 37
