Research-based pharmaceutical company BioInvent International has treated the first patient in a Phase II study of BI-505 in smoldering multiple myeloma.
Patients with asymptomatic myeloma (smoldering multiple myeloma) who have not developed symptoms of disease, where the condition can be detected only in laboratory tests, will participate in the study.
The current study involves up to 10 patients and evaluates disease activity following treatment with BI-505.
Secondary objectives include safety, pharmacokinetics and assessment of biomarkers.
BioInvent CEO Cristina Glad said BI-505 marks BioInvent's capability to initiate in-house clinical projects using the company's FIRST technology and biological expertise.
"The first clinical study of BI-505 achieved our goals. The candidate drug was well tolerated and indicated therapeutic effect, since seven of a total of 29 patients with advanced multiple myeloma demonstrated stable disease for at least two months," Glad said.
"The start of this Phase II study is another important step forward for BI-505 and we believe that BI-505 has the potential to address a major unmet need in a broad population of patients."
Human antibody BI-505, which specifically binds to the ICAM-1 adhesion protein, was developed for the treatment of multiple myeloma.