Shares of ArQule ($ARQL) plunged this morning after its Japanese partner on the closely-watched cancer drug tivantinib alerted the biotech that it temporarily suspended enrollment in its Phase III trial for non-small cell lung cancer after spotting signs of lung disease in patients.
Kyowa Hakko said it curtailed enrollment after a safety committee reported cases of interstitial lung disease, a condition afflicting the tissue and space around the air sacs in the lung, in the study. "The SRC has requested additional information and analyses regarding these cases of ILD which showed an imbalance between the arms of the trial," ArQule noted in an 8-K filed with the SEC. "During review of the additional information, treatment of patients already enrolled in the study is continuing pursuant to the protocol for the study. Updates on the status of this review and a determination regarding whether to restart patient enrollment will be provided as warranted."
ArQule--which saw its shares slide 22% this morning--and Daiichi Sankyo are engaged in an ambitious late-stage program for tivantinib. Interim results from their Phase III MARQUEE study are due in the second half of this year, after half of the planned patient deaths occur. A final analysis is due out next year.
Kyowa signed on in a regional pact covering Japan and parts of Asia, including South Korea, Taiwan and China.
- here's the 8-K
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