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news.Human Genome Sciences and GlaxoSmithKline have initiated dosing in one of two phase III trials of LymphoStat-B in patients with lupus.
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LymphoStat-B is being developed by the companies under a definitive development and commercialization agreement entered into in August 2006.
The program includes two phase III superiority trials to evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care, in the treatment of patients with active systemic lupus erythematosus (SLE).
HGS has initiated dosing in the first phase III trial in which the duration of therapy will be 76 weeks. The second phase III trial is expected to begin in the first half of 2007 and in which the duration will be 52 weeks.
The primary efficacy endpoint of both studies is the patient response rate at week 52. Important secondary endpoints will include the patient response rate at week 76, the SF-36 Health Survey physical component summary score, fatigue measures, and the percentage of patients with reduction from baseline in average prednisone dose at weeks 40 to 52.
The results of a phase II trial of LymphoStat-B in patients with active SLE show that LymphoStat-B produced statistically significant reductions in disease activity versus placebo.
It also exhibited clinically relevant biological activity, and appeared generally safe and well tolerated with frequency and severity of adverse events similar to placebo and no increase at higher doses.