MHRA suspends clinical trial following adverse reactions
Following the admission of six participants to intensive care, the Medicines and Healthcare products Regulatory Agency (MHRA) has suspended a phase I clinical trial of a biologic product under development for the treatment of chronic inflammatory conditions - such as multiple sclerosis and rheumatoid arthritis - and leukaemia.
Following the admission of six participants to intensive care, the Medicines and Healthcare products Regulatory Agency (MHRA) has suspended a phase I clinical trial of a biologic product under development for the treatment of chronic inflammatory conditions - such as multiple sclerosis and rheumatoid arthritis - and leukaemia.
Eight men took part in the trial - which was being conducted by contract research organisation Parexel for biopharmaceutical company TeGenero, of Wuerzburg, Germany - with six receiving the product and two receiving placebo. Approved by the MHRA and the local ethics committee, the trial marked the first time the drug, TGN 1412, an immunomodulatory humanised agonistic anti-CD28 monoclonal antibody, had been introduced into humans.
"The drug was developed in accordance with all regulatory and clinical guidelines and standards," said Dr Thomas Hanke, chief scientific officer, TeGenero. "In preclinical studies, TGN1412 has been shown to be safe and the reactions which occurred in these volunteers were completely unexpected. Our first concern right now is for the patients and families and that they get all treatment possible."
"Such an adverse reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Professor Herman Scholtz, md and head of clinical pharmacology at Parexel. "We did everything possible to get the volunteers treated as quickly as possible."
The MHRA has notified other European regulatory bodies of the events and will be sending inspectors to the site of the trial - Northwick Park Hospital, London, - as part of its investigations, which it is conducting with the North West London Strategic Health Authority, the UK Department of Health and the Metropolitan Police.
"Our immediate priority has been to ensure that no further patients are harmed," said Professor Kent Woods, ceo of the MHRA. "We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."