Tri­al ob­servers say ‘game over’ for XBiotech's failed PhI­II can­cer study, the lat­est in a long line of set­backs

There’s more bad news to re­port for XBiotech $XBIT.

A few weeks af­ter Eu­ro­pean reg­u­la­tors snubbed the com­pa­ny’s ap­pli­ca­tion to start mar­ket­ing its du­bi­ous can­cer drug Xilonix, the Austin-based biotech is back with the news that it’s halt­ing a Phase III colon can­cer study af­ter out­side ex­perts con­clud­ed it wasn’t work­ing.

Their con­clu­sion:

The IDMC had no safe­ty con­cerns from the un­blind­ed analy­sis. How­ev­er, the com­mit­tee rec­om­mend­ed the ear­ly ter­mi­na­tion of the study since the find­ings were not suf­fi­cient to meet ef­fi­ca­cy or the thresh­old for con­tin­u­a­tion, which in­volved a prospec­tive­ly de­fined ac­cep­tance bound­ary for the in­ter­im analy­sis of less than or equal to p = 0.08.

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