Ascletis begins Phase III trial into bevacizumab for treatment of recurrent glioblastoma
pharmafile | January 24, 2022 | News story | Sales and Marketing |Â Â Â
Ascletis Pharma has announced the dosing of the first patient in the Phase III registration clinical trial of ASC40, combined with bevacizumab, for the treatment of recurrent glioblastoma (rGBM). ASC40 is an oral, selective inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis (DNL).
The Phase III trial is a randomised, double-blind, placebo-controlled, multi-center clinical trial in China to evaluate progression-free survival (PFS), overall survival (OS), and safety of patients with rGBM. Around 180 patients will be 1:1 randomised to Cohort 1 (oral ASC40 tablet once daily + Bevacizumab) and Cohort 2 (matching placebo tablet once daily + Bevacizumab). Approximately 80% of such 180 patients with rGBM in the Phase III clinical trial are expected to be randomised and enrolled by the end of December 2022.
Glioblastoa (GBM) represents 57% of gliomas and has an incidence rate of approximately 2.85 to 4.56 per 100,000 population per year, indicating roughly 40,000 to 64,000 new cases of GBM per year. Over 90% GBM patients will relapse after surgery, radiation, and chemotherapies.
“I am pleased that the first patient has been successfully dosed in the Phase III clinical trial of ASC40 combined with bevacizumab for treatment of recurrent glioblastoma. As the first clinical trial targeting tumour lipid metabolism in China, we are looking forward to the results of the trial,” said Dr Wenbin Li, Vice Chairman and Secretary General of Glioma Committee of Chinese Cancer Association, Director of the Comprehensive Tumor Treatment Center, Beijing Tiantan Hospital, Capital Medical University.
Lina Adams
