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February 4, 2014
08:09 EDTARQLArQule announces commencement of tivantinib Phase 3 trial
ArQule reported the announcement by its partner, Kyowa Hakko Kirin of the initiation of a Phase 3 clinical trial evaluating tivantinib in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy. The trial is a randomized, double-blind placebo-controlled study to compare progression-free survival in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study. Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.
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November 17, 2015
07:35 EDTARQLArQule reports enrollment of first patient in Phase 1 Proteus syndrome trial
ArQule and the National Human Genome Research Institute, or NHGRI, of the National Institutes of Health, or NIH, announced enrollment of the first patient in the phase 1 clinical trial for Proteus syndrome. This trial, with ARQ 092, an orally available, selective pan-AKT inhibitor, marks the first clinical trial in this rare disease. Proteus syndrome is characterized by overgrowth of the skeleton, skin, adipose tissue and central nervous system. Additionally, ArQule received orphan drug designation from the FDA for ARQ 092 in Proteus syndrome. This marks an important regulatory milestone and the first orphan drug designation for this population. Proteus syndrome impacts fewer than one in a million people worldwide.
November 11, 2015
09:44 EDTARQLArQule granted orphan status for Proteus Syndrome treatment
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