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news.Genmab A/S and Medarex have obtained encouraging safety and efficacy data from a phase I/II trial using their co-developed fully human antibody to treat patients suffering from an unspecified autoimmune disease. Results show that the treatment achieved statistical significance after eight weeks.
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In the trial, 57% of patients who completed the study achieved a 50% or more reduction, compared with baseline, in the primary endpoint measure of disease activity one week after final dosing, at week eight. In the highest dose group (8/4mg/kg) all seven patients saw a 50% or more reduction in disease activity.
At the timepoint of one week after the initial dose, 14 patients were seen to achieve a 50% or more reduction in disease activity with five out of seven patients in the highest dose group seeing this level of disease improvement.
In a pooled analysis of all dose groups after eight weeks, a statistically significant mean reduction in disease activity of 56% was seen.
Neither serious adverse event reported (one event of syncope and one event of acute myocardial infarction) were determined by the investigator to be related to the fully human antibody, HuMax-Inflam/MDX-018. No dose limiting toxicity was reported after administration of doses up to 8mg/kg, and it is believed that the maximum tolerated dose was not reached.