ASLAN Announces First Patient Enrolled In A Global Phase II/III Study For Varlitinib In Gastric Cancer
Singapore, 31 August 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 the enrolment of the first patient in a global phase 2/3 study investigating varlitinib as first line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients.
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.
The global phase 2/3 study is a double blind, randomised two-arm study that aims to determine the efficacy of varlitinib in combination with mFOLFOX6 (a combination chemotherapy regimen) in comparison to mFOLFOX6 alone in the first-line setting. The first part of the study will enrol 40 HER1/HER2 coexpressing patients who were not exposed to prior systemic therapy and will read out in 2018.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “Today’s news marks an important milestone for ASLAN as we treat the first patient in a further global late stage study of varlitinib, the second that we have initiated this year. Varlitinib has the potential to be an important first line therapeutic for metastatic or advance-stage gastric cancer patients who currently have very limited treatment options.”
Gastric cancer currently ranks fourth in cancer incidence worldwide[1] and is one of the most common types of cancer in Asia[2].
Varlitinib is also currently being investigated in a global pivotal trial in biliary tract cancer (BTC). Varlitinib has been awarded the Orphan Drug Designation (ODD) by the Korea MFDS for BTC. An ODD status was also granted by the US FDA for varlitinib in gastric cancer and cholangiocarcinoma.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4768187/
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000485/
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 the USA 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.
The global phase 2/3 study is a double blind, randomised two-arm study that aims to determine the efficacy of varlitinib in combination with mFOLFOX6 (a combination chemotherapy regimen) in comparison to mFOLFOX6 alone in the first-line setting. The first part of the study will enrol 40 HER1/HER2 coexpressing patients who were not exposed to prior systemic therapy and will read out in 2018.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “Today’s news marks an important milestone for ASLAN as we treat the first patient in a further global late stage study of varlitinib, the second that we have initiated this year. Varlitinib has the potential to be an important first line therapeutic for metastatic or advance-stage gastric cancer patients who currently have very limited treatment options.”
Gastric cancer currently ranks fourth in cancer incidence worldwide[1] and is one of the most common types of cancer in Asia[2].
Varlitinib is also currently being investigated in a global pivotal trial in biliary tract cancer (BTC). Varlitinib has been awarded the Orphan Drug Designation (ODD) by the Korea MFDS for BTC. An ODD status was also granted by the US FDA for varlitinib in gastric cancer and cholangiocarcinoma.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4768187/
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4000485/
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 the USA 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