FDA forces trou­bled Ad­vax­is to halt en­roll­ment on its PhI­II study for lead drug ax­al­imo­gene

A lit­tle more than a month af­ter Am­gen qui­et­ly walked away from its $65 mil­lion up­front to part­ner with Ad­vax­is $ADXS on ax­al­imo­gene filolis­bac, the biotech is re­port­ing that the FDA has slapped the pro­gram with a par­tial hold or­der­ing a stop to new en­roll­ment in the Phase III. And this isn’t the first time.

Ac­cord­ing to the com­pa­ny’s re­lease, reg­u­la­tors trig­gered the hold on their study for cer­vi­cal can­cer due to “re­quests for ad­di­tion­al in­for­ma­tion per­tain­ing to cer­tain AX­AL chem­istry, man­u­fac­tur­ing and con­trols (CMC) mat­ters.” No new safe­ty is­sues were iden­ti­fied, ac­cord­ing to the biotech.

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