Car­dio event forces FDA to halt a Penn PhII study for mul­ti­ple myelo­ma

Just a few months af­ter be­gin­ning a Phase II clin­i­cal tri­al of a new mul­ti­ple myelo­ma drug, in­ves­ti­ga­tors at the Uni­ver­si­ty of Penn­syl­va­nia have been put on a full clin­i­cal hold by the FDA. The hold was an­nounced by BioIn­vent STO:BINV, a Swedish biotech which was spon­sor­ing the Penn in­ves­ti­ga­tors’ work on the study.

Reg­u­la­tors have called up BioIn­vent with a warn­ing that a pa­tient tak­ing the an­ti­body BI-505 — which tar­gets ICAM-1, a pro­tein on the sur­face of can­cer cells — has ex­pe­ri­enced an ad­verse car­diopul­monary event in the study, forc­ing the hold, ac­cord­ing to a terse state­ment. In a full clin­i­cal hold, in­ves­ti­ga­tors are pre­vent­ed from any fur­ther dos­ing un­til the agency hits the green light to al­low them to pro­ceed.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.