Results from the trial earlier in the year showed that the drug lymphostat-B failed to produce good results and reduce lupus symptoms. The company decided to extend the trial to investigate the drug further.
In the extended 76-week study, the percentage of lupus patients who achieved the combined response rate selected as the primary efficacy endpoint was 46% at week 52 which increased to 56% at week 76, with no increase in infections or infectious events observed over time. The study showed that lymphostat-B exhibited durable biological activity and appeared safe and well tolerated.
“The data that have emerged from the 24-week extension of the phase II trial of lymphostat-B show continued improvement beyond the first 52 weeks of treatment,” said Daniel Wallace, clinical professor of medicine, David Geffen School of Medicine, UCLA.
Human Genome Sciences said it was preparing to initiate phase III trials before the end of 2006.