A phase II study evaluating the investigational agent BI-505 for patients with multiple myeloma (MM) was placed on full clinical hold by the U.S. Food and Drug Administration (FDA) due to risk of adverse cardiopulmonary events. The trial is assessing whether treatment with BI-505 could deepen therapeutic response and prevent or delay relapse in patients undergoing autologous hematopoietic cell transplantation with high-dose melphalan.
A phase I trial of patients with relapsed/refractory MM indicated that BI-505 had good safety outcomes, as well as “signs of a positive effect against the disease,” according to the study results that were published in 2015 in Clinical Cancer Research. The FDA and European Medicines Agency previously granted orphan drug designation for BI-505.
Source: BioInvent International press release, November 9, 2016.