Swedish biotech BioInvent (STO:BINV) has been told by the FDA to stop dosing multiple myeloma patients in its Phase II test for BI-505 due to safety concerns.
In a brief update, the biotech said the full clinical hold was prompted by an “adverse cardiopulmonary event” in the study--although no further details were given as its exec team awaits a written confirmation of the halt.
The BI-505 test is being carried out by BioInvent with investigators at the University of Pennsylvania, and was geared up to assess the ability of BI-505 to see if it could prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation with high-dose melphalan.
“BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report,” the company said.
It is also working on BI-1206, in Phase I/II for non-Hodgkin’s lymphoma and chronic lymphatic leukemia, and has tie-ups with a number of academic centers and pharmas, including Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma.
BioInvent, listed on the Stockholm market, saw its shares plummet 22% on the news this morning.