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.
BioInvent and Penn launched recruitment for the study back in April, setting out to demonstrate its ability to deepen patients’ response to autologous stem cell transplantation with high-dose melphalan. The primary endpoint they were tracking was the proportion of patients achieving stringent complete response to therapy, with about 45 patients getting the antibody add-on and 45 going without.
After the first 100-day response, patients were to be followed for three years to gauge its efficacy for progression-free survival.
BioInvent says it plans to follow up with the agency on getting the hold lifted as expeditiously as possible.
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