BioInvent Announces Approval to start Phase I Trial for BI-505 in Multiple Myeloma
News Aug 12, 2009
BioInvent International AB has announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase I open dose-escalation study with its therapeutic cancer antibody BI-505 in patients with advanced Multiple Myeloma.
The Phase I study will investigate safety, pharmacokinetics, pharmacodynamics, and will aim to define the optimal biological dose of the antibody for phase 2 drug development. BioInvent will recruit approximately 40 patients with advanced Multiple Myeloma across 3 centres (possibly extending to 4) in the U.S. as part of the study.
BI-505 is a fully human antibody derived from BioInvent’s proprietary n-CoDeR® library and targets the adhesion molecular ICAM-1 leading to cell death. ICAM-1 is highly expressed in several tumors but is not widely expressed in normal tissue.
Preclinical results have demonstrated that the compound is more efficacious to fight tumors than existing drugs. BI-505 has been granted orphan drug designation in the U.S. and Europe for the indication of Multiple Myeloma.
Svein Mathisen, CEO of BioInvent, commented, “We are delighted that the FDA accepted our first IND, an important step in the development of the company as we further increase our presence in the U.S. BI-505 is our fourth product in clinical development. We believe that it has application in multiple myeloma patients resistant to other therapies, as in many cases expression of ICAM-1 in tumor cells is known to be up-regulated. This, together with strong pre-clinical results compared to the current marketed drug for the indication, suggests that BI-505 could address major unmet medical need, both in multiple myeloma and potentially other indications.”
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