The Swedish biotechnology company, BioInvent, has announced it has terminated a Phase I/ II trial of its lead drug BI-505 as a treatment in conjunction with high-dose therapy and stem cell transplantation (HDT-SCT) for newly diagnosed myeloma patients. This follows the verbal notice issued in November 2016 by the US Food and Drug Administration (FDA) to halt further dosing of patients in the trial after an adverse cardiopulmonary event had been reported. BI-505 is a fully human monoclonal antibody targeting intercellular adhesion molecule 1 (ICAM-1) which is highly expressed by myeloma cells. The primary aim of the trial was to determine the ability of BI-505 to deepen responses to HDT-SCT and improve progression-free survival. The company has previously terminated a Phase II trial of BI-505 for smouldering myeloma.

 

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