Massachusetts biotech ArQule ($ARQL) is soldiering on in a Phase III trial of tivantinib, getting word from its data monitoring committee that the drug is doing fine despite a dosing reduction that once threatened to derail its development. The news stoked hopes that the company can finally get its liver cancer treatment across the goal line and sent shares up nearly 30%.
In the fall, ArQule and partner Daiichi Sankyo announced plans to halve doses of tivantinib in the Phase III study after cases of neutropenia raised safety concerns, tanking ArQule's shares and casting further doubt on a long-troubled drug. However, after a review of the data, investigators say the dosing fix has reduced neutropenia incidence without significantly changing patients' plasma exposure to tivantinib, ArQule said, recommending the company keep rolling with its study.
ArQule is developing tivantinib for hepatocellular carcinoma, its latest target in a checkered effort to find a home for the drug. The company previously took a shot at treating colorectal cancer by combining its drug with Eli Lilly ($LLY) and Bristol-Myers Squibb's ($BMY) Erbitux, but that effort flunked Phase II last year. Before that, the company pulled the plug on a 1,000-patient Phase III trial in non-small cell lung cancer when data monitors projected there was no way tivantinib was going to meet its primary endpoint of improving overall survival.
Through it all, the company's shares have peaked and valleyed with each new bit of news, reaching $2.80 on Friday, their highest mark since the spring.
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