ArQule shares jump on positive Phase II liver cancer data

Shares of ArQule ($ARQL) spiked more than 20 percent this morning after the biotech announced that its lead drug tivantinib achieved significant results in time-to-progression for patients suffering from a common variety of liver cancer. During the single-agent study, which enrolled 107 patients, investigators lowered the dose in use from 360 mg to 240 mg, which helped reduce the rate of neutropenia and anemia.

Investigators concluded that the treatment hit its primary endpoint, producing a statistically significant 56 percent improvement in time-to-progression in the intent-to-treat population.

"These findings represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC," said Dr. Brian Schwartz, chief medical officer of Woburn, MA-based ArQule. "Second line treatment for HCC remains a challenge, lacking an approved agent. We look forward to presenting complete data from this trial at a peer-reviewed forum later this year, including secondary endpoint, sub-group and biomarker analyses."

The data release is also good news for Daiichi Sankyo, which signed a regional licensing pact on the drug back in 2008. Kyowa Hakko has Asian rights to the drug. Tivantinib is also the subject of two late-stage studies for non-small cell lung cancer.

- here's the press release

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