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January
7th 2004. On
December 23, Celltech (NYSE:CLL) commenced dosing of patients in the
first of two phase III investigations of CDP870 in Crohn disease.
This study is called PRECISE-1 (Pegylated antibody fRagment
Evaluation In Crohn’s dIsease: Safety and Efficacy-1), with
PRECISE-2 slated for initiation later this month. This
international, phase III registration program, expected to enroll
more than 1,300 patients, will evaluate subcutaneous CDP870’s
utility for the induction and maintenance of clinical response in
patients with moderate to severe Crohn disease. The construct’s
ability to generate sustained therapeutic responses over a broad
population remains suspect.
CDP870
is a pegylated, anti-TNF-alpha monoclonal antibody fragment. TNF-alpha
is a cytokine (small hormone-like protein that transmits signals
between cells) important in immune responses and inflammation.
Amgen’s (NASDAQ: AMGN) Enbrel, Johnson & Johnson’s (NYSE:
JNJ) Remicade, and Abbott’s (NYSE: ABT) Humira are marketed TNF-alpha
inhibitors. Celltech shares have been under pressure since
mid-November when Pfizer’s (NYSE: PFE) request to re-negotiate the
terms of its collaboration with Celltech to develop CDP870 raised
further doubts about the viability of the program.
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