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news.A pivotal phase III trial into UCB Pharmaceuticals' Cimzia showed that one 400mg injection of the drug every four weeks was effective in maintaining control of the signs and symptoms of Crohn's disease following induction therapy.
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The research, presented this week at the annual meeting of the American College of Gastroenterology, found that a significantly higher proportion of patients who responded to an induction regimen of 400 mg Cimzia at weeks zero, two and six, were able to maintain clinical response and achieve remission by week 26 when given a single injection every four weeks, compared to those treated with placebo.
A regulatory submission for the treatment of Crohn’s disease is planned in the US during the first quarter of 2006.
“As there is considerable unmet need in the treatment of Crohn’s disease, it is important that the research community continue to explore new therapies,” said Dr William Sandborn, professor of medicine, Mayo Clinic College of Medicine, Rochester, MN, PRECiSE study investigator. “These data are exciting because it shows that Cimzia holds significant promise in meeting many of these needs.”
Cimzia is a biologic agent that has been designed to inhibit the production of tumor necrosis factor alpha (TNF-alpha), a protein involved in the inflammation process associated with Crohn’s disease.