A phase II study of the investigational antibody BI-505 for patients with multiple myeloma (MM) was terminated after being put on a clinical hold last month following the discovery of the risk of adverse cardiopulmonary events.
The trial was 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.
BioInvent International – the drug’s manufacturer – is in talks with the U.S. Food and Drug Administration (FDA) about potentially developing the drug for use in other patient populations.
BI-505 received orphan drug designation as a treatment for MM from both the FDA and the European Medicines Agency.
Source: BioInvent International press release, December 12, 2016.