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Hangzhou and Shaoxing, China, January 23, 2022 /PRNewswire/ — Ascletis Pharma Inc. (SEHK: 1672) today announced the dosing of the first patient in a Phase III registrational clinical trial of ASC40 in combination with bevacizumab in relapsed glioblastoma (rGBM) . ASC40 is an oral, selective inhibitor of fatty acid synthase (FASN), a key enzyme regulating de novo lipogenesis (DNL). ASC40 inhibits energy supply and perturbs the membrane phospholipid composition of tumor cells by blocking de novo lipogenesis.
The Phase III registration study (ClinicalTrials.gov identifier: NCT05118776) was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China To evaluate progression-free survival (PFS), overall survival (OS), and safety in patients with rGBM. Approximately 180 patients were randomized 1:1 to cohort 1 (once-daily oral ASC40 tablet + bevacizumab) and cohort 2 (once-daily matching placebo tablet + bevacizumab).Approximately 80% of these 180 rGBM patients are expected to be in the Phase III clinical trial December 2022.
A Phase II study in patients with rGBM completed in the United States demonstrated an objective response rate (ORR) of 65% with ASC40 plus bevacizumab, including 20% complete response (CR) and 20% partial response (PR) 45 %.
According to published data, in China, Glioblastoma (GBM) accounts for 57% of gliomas, with an incidence of approximately 2.85 to 4.56 cases per 100,000 people per year, which indicates approximately 40,000 to 64,000 new GBM cases…
The full story is available on Benzinga.com
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