January 17, 2012

ArQule advances drug candidate for liver cancer

Boston Business Journal by Julie M. Donnelly, Reporter
Date: Tuesday, January 17, 2012, 9:12am EST

ArQule Inc. (NASDAQ: ARQL) Said Tuesday that its experimental therapy for the most common form of liver cancer showed positive results in a Phase 2 trial. The Woburn, Mass. biotech said the drug target, tivantinib, when used alone, extended the cancer's time to progression by 56 percent. There are few approved treatments for liver cancer outside of traditional chemotherapy.

The 107 patients in the study either had continued to see their disease progress on currently approved treatments, or could not tolerate them.

The most common primary cancer of the liver, Hepatocellular carcinoma, (HCC) has risen to be the third leading cause of cancer-related death, the company said

“These findings represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC,” ArQule chief medical officer Dr. Brian Schwartz said in a statement. “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 company reported that side effects of the drug candidate include fatigue neutropenia and anemia. The company said the risk of neutropenia and anemia declined after lowering the dosage of tivantinib.

The company is also studying the potential therapy in two Phase 3 trials to treat non-small cell lung cancer.

The drug candidate is part of a 2008 partnership agreement between ArQule and Japanese drug maker Daiichi Sankyo, Co. Ltd. to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co. Ltd. has exclusive rights for development and commercialization of tivantinib.

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