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news.Genmab, a Danish pharmaceutical company, has reported preliminary safety and efficacy data of daratumumab (HuMax-CD38) in multiple myeloma, from the first Phase I/II clinical study.
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Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity and is in clinical development for multiple myeloma.
This ongoing Phase I/II dose escalation study comprised 122 patients with multiple myeloma that is relapsed or refractory to at least two different prior treatments.
The primary objective of the study is to determine the safety profile of daratumumab and secondary objectives are to determine maximum tolerated dose and efficacy.
Genmab CEO Jan van de Winkel said they have not the preliminary data offers the first insight into the activity of daratumumab in multiple myeloma.
"We have not yet reached the maximum tolerated dose and therefore the study will continue to examine patients at higher doses and we look forward to announcing detailed safety and response data at a later date," Winkel added.