ASLAN Announces First Patient Enrolled In Global Pivotal Treetopp Study For Varlitinib In Biliary Tract Cancer
Singapore, 29 June 2017 – ASLAN Pharmaceuticals (ASLAN, 6497.TT), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced that it has enrolled its first patient in the TreeTopp study, a global pivotal trial investigating varlitinib in biliary tract cancer.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor and is currently being developed across multiple indications including biliary tract, gastric, metastatic breast and metastatic colorectal cancers. Currently, there are no approved therapies for the treatment of biliary tract cancer, and the TreeTopp (Treatment Opportunity with varlitinib in biliary tract cancer) study may enable accelerated approval by the US FDA.
The global, pivotal double-blind, randomised two-arm study aims to determine the safety and efficacy of varlitinib in combination with capecitabine for the treatment of biliary tract cancer, and will enrol approximately 120 patients, who have failed first line therapy, from 60 sites worldwide. The primary endpoint of the study will be Objective Response Rate.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “The enrolment of the first patient into the TreeTopp study is a milestone for ASLAN as we work to develop a targeted therapy that treats biliary tract cancer, a disease that is an aggressive form of cancer with poor prognosis. We are making very good progress in the development of varlitinib as a potential treatment for tumour types for which current treatment options are limited. TreeTopp is a pivotal study that we have initiated this year and will provide important data to support our registration filings.”
Varlitinib has been awarded Orphan Drug Designation (ODD) by the US FDA for cholangiocarcinoma. It also received the ODD designation from the Korea FDA for biliary tract cancer.
ENDS
Media contacts
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a potent small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The type I RTK family consists of four distinct but closely related receptors: epidermal growth factor receptor (EGFR, ErbB1, HER1), epidermal growth factor receptor 2 (HER2, ErbB2), epidermal growth factor receptor 3 (HER3, ErbB3), and epidermal growth factor receptor 4 (HER4, ErbB4). Varlitinib is a potent, reversible, small molecule inhibitor of EGFR, HER2 and HER4. In a large variety of cancers, the overexpression and/or constitutive activation of EGFR and HER2 are often observed and frequently correlate with poor clinical prognosis. Therefore, by inhibiting the activation of the HER receptors via varlitinib, effects such as shrinkage of the tumour and longer survival can be anticipated. Varlitinib is currently being studied in biliary tract, breast and gastric cancers. Varlitinib has been granted orphan drug status in United States for cholangiocarcinoma and gastric cancer and was awarded orphan drug status for the treatment of advanced biliary tract cancer after first line systemic therapy by the Korean MFDS.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (6497.TT) is an oncology focused biotechnology company developing a portfolio of immunotherapies and targeted drugs, focusing on Asia prevalent tumour types. Led by a highly experienced management team with global pharmaceutical expertise, ASLAN is headquartered in Singapore with a platform that reaches across the region via its offices in Taiwan, China and Australia. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and colorectal cancer, and has two global pivotal studies in biliary tract cancer and gastric cancer underway. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. www.aslanpharma.com
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor and is currently being developed across multiple indications including biliary tract, gastric, metastatic breast and metastatic colorectal cancers. Currently, there are no approved therapies for the treatment of biliary tract cancer, and the TreeTopp (Treatment Opportunity with varlitinib in biliary tract cancer) study may enable accelerated approval by the US FDA.
The global, pivotal double-blind, randomised two-arm study aims to determine the safety and efficacy of varlitinib in combination with capecitabine for the treatment of biliary tract cancer, and will enrol approximately 120 patients, who have failed first line therapy, from 60 sites worldwide. The primary endpoint of the study will be Objective Response Rate.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “The enrolment of the first patient into the TreeTopp study is a milestone for ASLAN as we work to develop a targeted therapy that treats biliary tract cancer, a disease that is an aggressive form of cancer with poor prognosis. We are making very good progress in the development of varlitinib as a potential treatment for tumour types for which current treatment options are limited. TreeTopp is a pivotal study that we have initiated this year and will provide important data to support our registration filings.”
Varlitinib has been awarded Orphan Drug Designation (ODD) by the US FDA for cholangiocarcinoma. It also received the ODD designation from the Korea FDA for biliary tract cancer.
ENDS
Media contacts
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a potent small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The type I RTK family consists of four distinct but closely related receptors: epidermal growth factor receptor (EGFR, ErbB1, HER1), epidermal growth factor receptor 2 (HER2, ErbB2), epidermal growth factor receptor 3 (HER3, ErbB3), and epidermal growth factor receptor 4 (HER4, ErbB4). Varlitinib is a potent, reversible, small molecule inhibitor of EGFR, HER2 and HER4. In a large variety of cancers, the overexpression and/or constitutive activation of EGFR and HER2 are often observed and frequently correlate with poor clinical prognosis. Therefore, by inhibiting the activation of the HER receptors via varlitinib, effects such as shrinkage of the tumour and longer survival can be anticipated. Varlitinib is currently being studied in biliary tract, breast and gastric cancers. Varlitinib has been granted orphan drug status in United States for cholangiocarcinoma and gastric cancer and was awarded orphan drug status for the treatment of advanced biliary tract cancer after first line systemic therapy by the Korean MFDS.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (6497.TT) is an oncology focused biotechnology company developing a portfolio of immunotherapies and targeted drugs, focusing on Asia prevalent tumour types. Led by a highly experienced management team with global pharmaceutical expertise, ASLAN is headquartered in Singapore with a platform that reaches across the region via its offices in Taiwan, China and Australia. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and colorectal cancer, and has two global pivotal studies in biliary tract cancer and gastric cancer underway. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. www.aslanpharma.com