), 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
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
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
ArQule currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the pharmaceutical industry include
Lannett Company, Inc
). While Salix Pharma and Endocyte carry a Zacks Rank #1 (Strong
Buy), Lannett is a Zacks Rank #2 (Buy) stock.
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