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news.ArQule, a biotechnology company, has expanded its clinical development program for ARQ 197, an orally administered small molecule inhibitor of the c-Met receptor tyrosine kinase, with a new target indication, hepatocellular carcinoma.
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ArQule and Daiichi Sankyo have previously signed a license, co-development and co-commercialization agreement to co-develop ARQ 197 in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co has exclusive rights for development and commercialization.
In addition to hepatocellular carcinoma (HCC), ArQule has ongoing Phase II clinical trial programs in the following indications: microphthalmia transcription factor-associated tumors, non-small cell lung cancer and pancreatic adenocarcinoma.
Brian Schwartz, chief medical officer of ArQule, said: “Following the recent completion of a strategic review of clinical targets and commercial pathways, as well as discussions with key opinion leaders and our partner, Daiichi Sankyo, we have added HCC as the fourth indication in our clinical trial program for ARQ 197.
“We have dosed the first HCC patient in a pilot safety study with ARQ 197 as monotherapy. Pending its successful completion, we will move into a Phase II, single agent trial and also explore a Phase I-II combination therapy trial program with sorafenib.”