23 September 2015 | News | By BioSpectrum Bureau
Aslan recieves Singapore, Taiwan nod for Ph II trial of bile duct cancer drug
ASLAN001 (varlitinib) is in trial for second-line cholangiocarcinoma, an aggressive form of bile duct cancer
Singapore: Singapore based ASLAN Pharmaceuticals, a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, has recieved simultaneous approval of its clinical trial applications (CTA) in Singapore and Taiwan to conduct a phase 2 study to assess the efficacy of ASLAN001 (varlitinib) in second-line cholangiocarcinoma, an aggressive form of bile duct cancer with no approved therapy and a very poor prognosis.
ASLAN001 has been demostrated to be efficacious as both monotherapy and in combination with chemotherapy in cholangiocarcinoma. This phase 2 study will further evaluate its efficacy in a larger group of patients. ASLAN001 received orphan drug designation from the US FDA in August 2015.
"We are very pleased to see the fast response of the Singapore Health Services Authority and the Taiwan Food and Drug Administration, allowing us to run a study in this patient population where there is such significant unmet need," said Dr Mark McHale, chief Operating Officer, ASLAN Pharmaceuticals.
"This will be the first systematic test of the efficacy of our pan-HER inhibitor, ASLAN001, in cholangiocarcinoma, and builds on the recent collaborations we have established in Singapore with the National Cancer Centre of Singapore and in Taiwan with ACT Genomics to understand this disease better," he said.