Phase I antibody risks, trial safety examined.

Antibody therapies are the subject of discussion on both sides of the Atlantic this year. Britain and Germany are dealing with the serious fallout of a phase I trial this spring, and U.S. regulatory agencies are working to settle issues of dosing and treatment of antibody therapies in phase I trials. The phase I trial, using a drug developed by the German company TeGenero AG, is part of a new wave of immune system – altering antibodies being developed to treat cancer and other ailments. More than 20 other antibody therapies have either been approved for use in humans or are in late-stage clinical development, yet many scientists view these new agents as riskier than traditional antibody therapies, which do not bind to immune system targets. Despite their concern, several scientists said the problem in the British trial, which put six people in the hospital, was likely with the TeGenero drug itself rather than antibody therapies as a whole. But antibody therapy is still under federal scrutiny. Britain has temporarily restricted phase I trials of new antibodies, regardless of their target, as well as other immune system agents. “ I think the TGN outcome has always been a concern for anybody taking a novel therapy into clinical development, ” said Stephen M. Kelsey , M.D., senior group medical director of exploratory clinical development for Genentech BioOncology. “ If we are prepared to do clinical trials on human beings, then we are going to have to accept that there can always be unexpected safety outcomes, which may occur with varying degrees of frequency and varying degrees of severity. What these guys met, unfortunately, was the perfect storm of very severe and very frequent. ”