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Aslan pharmaceuticals announces first patient enrolled in phase 1 study of Varlitinib in japan

Clinical Trials

ASLAN Pharmaceuticals , a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types announced that they are initiating enrolment of the first patient in the phase 1 clinical trial for varlitinib (ASLAN001) in biliary tract cancer in Japan.

Varlitinib is a potent reversible small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs).The study is expected to enrol up to 36 Japanese patients. Designed in collaboration with Japanese medical experts, the open-label study is open to all patients with solid tumours and biliary tract cancer. The primary study objective is to characterise the safety and tolerability of varlitinib as monotherapy and in combination with capecitabine in Japanese patients with biliary tract cancer.

This will make possible for Japanese patients join the global study in varlitinib in biliary tract cancer. Enrolment is planned at two clinical sites in Japan. 

Dr Bertil Lindmark, Chief Medical Officer, ASLAN said: "Biliary tract cancer is an aggressive form of cancer with poor prognosis and no therapies have shown meaningful efficacy after first line chemotherapy. More commonly found in Asia, the number of biliary tract cancer patients has been steadily increasing over the years. “The first patient in in Japan is a significant milestone for ASLAN as we progress the clinical development of varlitinib

into pivotal stage, and potentially develop a targeted treatment for patients in Japan and Asia.” Varlitinib has received Orphan Drug Designation for biliary tract cancer and gastric cancer from the US Food and Drug Administration. 

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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.

About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals 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, enabling the Company to conduct and support regional clinical development programmes. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric c ancer and breast cancer. ASLAN has several compounds in late stage development: varlitinib (ASLAN001), a pan-HER inhibitor which has completed phase 2 studies in gastric and breast cancer, and is entering pivotal studies for biliary tract cancer; and ASLAN002 (partnered with BMS), a RON and cMET inhibitor in phase 2development for gastric and breast cancer. www.aslanpharma.com


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