Two UK industry bodies have formed a taskforce to provide input to the investigation in the UK of early-stage clinical trial design, convened after six men suffered serious side effects in a Phase I trial at a North London hospital.
The volunteers in the study received the drug, TeGenero’s TGN1412, at a dedicated clinical unit run by Parexel at Northwick Park Hospital in North London. They suffered almost immediate adverse reactions, leading to multiple organ failure, which caused them to be hospitalised.
And this prompted the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) to start the investigation last month to “consider what necessary changes to clinical trials may be required.”
The probe is led by Prof Gordon Duff, professor of molecular medicine at Sheffield University. It will look specifically at how trials should be designed and overseen for biological molecules with novel mechanisms of action, especially those targeted at the immune system and those with highly species-specific action. It is due to deliver a verdict in July.
An earlier MHRA investigation found that the most likely cause of the adverse events was an unexpected effect of the drug that could not have been predicted in laboratory testing, rather than a result of deviation from the agreed trial protocol or a manufacturing error.
However, two experts, cited by the BBC yesterday, have suggested that the effect should have been predictable using different tests than those employed by TeGenero – with the backing of regulators – because TGN1412’s mode of action is different from other antibodies that have gone through clinical testing in the past. The drug is a new class of monoclonal antibody which has a stimulatory mode of action.
The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) said yesterday the taskforce would be co-chaired by Dr David Chiswell and Sir Colin Dollery and include industry experts in fields such as immunology, biopharmaceutical development and clinical trials.
David Chiswell is chairman of the BIA and was a founder of Cambridge Antibody Technology, set to be acquired by AstraZeneca for $1.3 billion. He also holds board positions at Sosei, Arrow Therapeutics and Daniolabs. Sir Colin is a senior R&D consultant for GlaxoSmithKline and has particular expertise in taking drugs from preclinical development into early studies in man.