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.
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