ArQule's (ARQL) Japanese Partner Temporarily Suspends Tivantinib Trial

August 29, 2012 8:54 AM EDT Send to a Friend
ArQule, Inc. (Nasdaq: ARQL) disclosed this morning that it was informed by its Asian partner Kyowa Hakko Kirin that it has temporarily suspend patient enrollment in its ongoing Phase 3 ATTENTION trial on the recommendation of an independent Safety Review Committee in Japan after the reporting of suspected cases of interstitial lung disease in the study.

From the filing:
ArQule, Inc. (ArQule) has been informed by Kyowa Hakko Kirin Co., Ltd. (Kyowa), which has exclusive development rights to tivantinib in Japan and certain parts of Asia, of Kyowa’s decision to temporarily suspend patient enrollment in its ongoing Phase 3 ATTENTION (Asian Trial of Tivantinib plus Erlotinib for NSCLC without EGFR Mutation) trial. The ATTENTION trial investigates the use of tivantinib and erlotinib versus erlotinib and placebo in second line non-squamous non-small cell lung cancer (NSCLC). This trial is being conducted by Kyowa in Japan, South Korea and Taiwan.

Kyowa has taken this action following the recommendation of an independent Safety Review Committee (SRC) in Japan after the reporting of suspected cases of interstitial lung disease (ILD) 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.

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.


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

FDA

Add Your Comment