"We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
The phase I study will investigate safety, pharmacokinetics and pharmacodynamics and will aim to define the optimal dose of the antibody for upcoming clinical phase II development. The study will involve 30 - 40 patients. The patients will be treated with intravenous doses of BI-505 every other week for a 28-day period with the possibility of extending the treatment until the condition deteriorates again. The study will be conducted at clinics in the US and will be overseen by renowned multiple myeloma experts.
Last year the US Food & Drug Administration (FDA) approved BioInvent's application to conduct a clinical trial with BI-505 in the US. BI-505 has also been granted orphan drug designation in the US and Europe for multiple myeloma.
BI-505 is a human antibody derived from BioInvent's proprietary n-CoDeR® library based on its ability to bind to a tumour-associated receptor (the adhesion molecule ICAM-1) and induce programmed cell death (apoptosis) in tumour cells. Preclinical studies have shown that the substance also activates the body's own (Fc:Fc gamma receptor dependent) anti-tumour mechanisms and fights cancer more effectively than existing drugs.
Svein Mathisen, CEO of BioInvent, commented: "We are delighted that the clinical studies of BI-505 have started. We believe that BI-505 can address a major unmet medical need and be an important treatment alternative for multiple myeloma."
Source
BioInvent International AB
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