ArQule (ARQL), a clinical-stage biotechnology company, recently announced that its partner Kyowa Hakko Kirin Co., Ltd. has initiated a phase III trial on tivantinib (ARQ 197) in Japan.
As per the agreement signed in Dec 2008, ArQule and Daiichi Sankyo Co., Ltd. have the license to co-develop and commercialize tivantinib in the U.S., Europe, South America and the rest of the world while Kyowa Hakko Kirin has exclusive rights for development and commercialization in Japan, China, South Korea and Taiwan.
The trial is being conducted among patients suffering from c-Met diagnostic-high inoperable hepatocellular carcinoma (HCC) who were previously treated with sorafenib therapy.
The phase III trial (n=160) will be a randomized double-blind placebo-controlled, evaluating progression-free survival (PFS) in patients treated with tivantinib as compared to those treated with placebo.
We note that ArQule is also evaluating tivantinib for the treatment of HCC (liver cancer) in the METIV-HCC trial in collaboration with Daiichi Sankyo Co., Ltd. The primary endpoint of the study is overall survival while the secondary endpoint is progression free survival.
In Sep 2013, ArQule announced that the Data Monitoring Committee (:DMC) of the METIV-HCC trial recommended that the study dosage should be brought down from 240 mg twice daily to 120 mg twice daily after a higher incidence of neutropenia was observed in the patient population in the phase III trial compared to the phase II trial.
The recent analysis from the study showed that the incidence of neutropenia was reduced in patients treated with 120 mg tivantinib tablets, administered twice daily.
ArQule currently does not have any marketed product in its portfolio and tivantinib is its most advanced stage candidate. Hence, we expect investor focus on futher updates on the phase III results.
ArQule currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical industry include Salix Pharmaceuticals (SLXP), Endocyte, Inc. (ECYT) and Lannett Company, Inc. (LCI). While Salix Pharma and Endocyte carry a Zacks Rank #1 (Strong Buy), Lannett is a Zacks Rank #2 (Buy) stock.