Research & Development
Senhwa Biosciences wins US FDA's approval for Silmitasertib's IND for the treatment of basal cell carcinoma
1 November 2018 -

Oncology company Senhwa Biosciences Inc (TPEx:6492) reported on Wednesday the receipt of the US FDA's approval for its IND application for its new drug Silmitasertib (CX-4945) for the treatment of basal cell carcinoma (BCC), the most common type of skin cancer, under the US FDA's draft guidance for clinical trial designs.

The company said Silmitasertib is a first-in-class small molecule drug that targets Casein kinase 2 (CK2), a protein involved in the DNA repair mechanism of cancer cells. Silmitasertib has achieved clinical benefit as a single-agent CK2 inhibitor, resulting in stable diseases and allowing extended duration of treatment in several patients as well as has shown synergistically improving the efficacy of anticancer treatments in combination with with DNA-damaging agents.

Currently, Silmitasertib is in a Phase 2 randomised trial for cholangiocarcinoma and has proven to be safe and well-tolerated in human. Currently clinical trial of Silmitasertib for medulloblastoma (MB) is under preparation and the trial is sponsored by Pediatric Brain Tumor Consortium (PBTC, US).

The global sales of the first targeted drug approved by US FDA for metastatic or locally advanced BCC, Erivedge (vismodegib), has generated the sales revenue of USD253m in 2017 (according to GlobalData) and is expected to peak at USD533m by 2022 (forecasted by Coven & Co's). The global business opportunities of BCC are predicted to grow at a compound growth rate of 9.2% from 2017 to 2025, according to the analysis of Transparency Market Research.

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