Celltech Group plc announced that it has completed a safetytrial for its potential septic shock treatment, a tumor necrosisfactor antagonist, earning the British company a $3.17 millionmilestone payment from Bayer AG.
Celltech administered a recombinant antibody to TNF to 18healthy volunteers to study its safety profile, pharmacokineticsand immunogenicity. The Slough, England, company said thehumanized antibody was "very well-tolerated, had a long half-life and evoked no problematic immune responses," attributesit considers "beneficial for both acute and chronic therapy."
Celltech has a multicenter Phase II trial near completion in 40septic shock patients. This ascending dose, placebo-controlledstudy will be reported this summer and will support a largerPhase II efficacy and safety study in septic shock with theCDP571 compound.
Also set to start in the second half of 1993 are clinical trials inrheumatoid arthritis and inflammatory bowel disease.
With results of the Phase I study, Celltech has met its firstclinical milestone in its alliance with the German parentcompany of Miles Inc. Miles is undertaking Phase III clinicalstudies with its murine monoclonal antibody against TNF calledBAY X1351.
"The clinical results clearly show important additional benefitsof novel 'human' antibodies compared with murine," said DavidBloxham, Celltech director of research. "This aspect opens manyexciting avenues for future clinical research."
In a $47.8 million deal last May, Bayer licensed Celltech'shumanized compound and will be responsible for its clinicaldevelopment after the Phase I trial completion. Celltechretained marketing rights in certain European countries andBayer obtained exclusive rights in the rest of the world.Celltech will also receive royalties on Bayer's sales.
Bayer said last spring it anticipates filing for marketingapproval in 1995 or 1996. -- Nancy Garcia
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