British pharmaceutical industry organizations say they are generally pleased with draft recommendations by a scientific expert panel for tighter rules governing phase 1 trials of “novel and potentially higher risk drugs…such as monoclonal antibodies.”
The UK government convened the panel earlier this year when six volunteers experienced very serious adverse effects from TGN1412, a T cell–targeting ‘super monoclonal antibody’ with an agonist activity developed by TeGenero of Würzburg, Germany (Nat. Biotechnol.24, 475–476 2006).
In an interim report released on July 25, 2006, the panel said that in higher risk studies “the first dose in man should be given to one person only, leaving sufficient time for any adverse reaction to develop before further administration or administration to additional people.”
The experts urged drug developers to inform regulators earlier about elevated risks and suggested enrolling people with the targeted disease rather than healthy volunteers into phase 1 trials of higher risk drug candidates “particularly if the drug is expected to affect the immune system.”
The recommendations generally echoed those published a day earlier by a joint task force of the Association of the British Pharmaceutical Industry and the UK BioIndustry Association, both based in London, including the proposal to set starting doses in first-in-man trials of biologicals below a point at which no biological effect is expected.
The industry task force, however, limited some of its advice to “novel agents stimulating the immune system,” excluding from extra scrutiny agents with inhibitory effects. Such agents, the task force writes, “are widely used” and “rarely have acute adverse effects.”
The expert panel is due to issue its final report in November.