ASLAN Announces First Patient Enrolled In Phase l Study Of Varlitinib In Japan
Singapore, 13 February 2017 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today 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.
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.