BioInvent International AB (OMXS:BINV) announce that the previously communicated positive results from a phase I trial of BI-505 is presented today at The International Myeloma Workshop in Kyoto, Japan. At the same meeting, preclinical data is also presented which demonstrate significantly enhanced efficacy when approved myeloma drugs are combined with BI-505. BI-505 is a human antibody directed against ICAM-1 and is developed for the treatment of multiple myeloma.
The results from the phase I study of BI-505 in patients with advanced multiple myeloma are presented by Associate Professor Markus Hansson at Lund University. The preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended treatment was available, 24 percent of the patients had stable disease for at least two months, indicating effect of BI-505.
At the same meeting, new preclinical data is also presented showing significantly enhanced anti-myeloma activity when the approved drugs Velcade® or Revlimid® is combined with BI-505 compared to single agent treatment. Combined treatment was evaluated in two different experimental models and the drugs were given in a similar way as to patients with myeloma. In one of the models enhanced survival was observed following combination therapy with BI-505, compared to single agent treatment with the approved drugs. In the second model, complete remission was observed in the majority of animals when combining BI-505 with Revlimid® or Velcade®.
Cristina Glad, CEO for BioInvent, commented: "We believe BI-505 has the potential to address a major unmet medical need in a broad population of patients with multiple myeloma. Based on the results from the phase I trial which are now presented at the international myeloma meeting, we have decided to continue our studies on BI-505 with a new smaller trial in patients with asymptomatic multiple myeloma (called "smoldering multiple myeloma"). The interesting preclinical studies showing enhanced anti-tumor effect when combining BI-505 with approved drugs, support to move forward with a clinical trial in which BI-505 is combined with another drug, representing a logic continuation of the clinical development process for our hitherto most advanced project."
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