ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, in September 2015, announced the 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.
Earlier studies have shown ASLAN001 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.
Carl Firth, Founder and Chief Executive Officer, ASLAN Pharmaceuticals, speaks with The Biotechnician about the significance of receiving approval from the Taiwan and Singapore government to conduct phase 2, and the future of tackling the rare and deadly disease- Cholangiocarcinoma.
The Biotechnician-Why is the regulatory approval from Taiwan and Singapore so important for this phase?
Carl Firth-With the encouraging data in cholangiocarcinoma we have seen in our previous studies, we are keen to progress this into larger and more focused studies to determine the benefit that ASLAN001 could provide to patients with cholangiocarcinoma. Given that there are no approved targeted therapies for this disease, the level of unmet need is high. Our study was approved very quickly in Singapore and Taiwan, in less than one month, allowing us to start our phase 2 study ahead of schedule.
The Biotechnician-What is the future of this study and when do you think it will make it to the market?
Carl Firth-In this study, we are initially recruiting 25 patients. In parallel, we will be having discussions with regulatory authorities in the US and in Asia to determine what additional data they will require for them to grant marketing approval. In the past, regulators have approved drugs for rare tumour types with as few as 25-50 patients, so if we similar responses in our new study as we saw in our earlier studies, it may be possible to secure accelerated approval for the drug.