SAEs the only similarity between the BIA 10-2474 trial and 'elephant man' study, says MHRA
Biotrial stopped the Phase I trial of BIA 10-2474 last week, prompting observers such as Sky News and the Telegraph to liken the incident to a UK trial that was suspended in 2006.
But any similarities to the earlier TGN1412 trial - later dubbed the "elephant man" study - are circumstantial says the MHRA, which told us the programmes had nothing in common in terms of protocols or in how they were conducted.
This is in keeping with information provided by French authorities so far.
According to Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) the “trial was approved last June 26…and received a favorable opinion from the Comité de Protection des Personnes Ouest VI [an independent review panel] on July 3, 2015.”
The Agency said the six injured volunteers had received “multiple” high doses of BIA 10-2474, which is a painkiller being developed by Portugal-based drugmaker Bial-Portela & Ca.
It also said no serious adverse events (SAEs) occurred during single-dose phases of the study.
This is in marked contrast with the TGN1412 trial in which the administration of a single dose of the drug – an antibody being trialled for autoimmune disorders by TeGenero Immuno Therapeutics – caused multiple organ failure in six volunteers.
Regulations
The other key difference between the BIA 10-2474 and TGN1412 studies is that all the volunteers in the latter programme eventually recovered.
Earlier today ANSM confirmed that one of the men hospitalised in the BIA 10-2474 trial had died. The other five men are being treated at University hospital in Rennes.
A report on the TGN1412 study prompted the UK to introduce a voluntary accreditation scheme for early phase research. It also moved the EMA to adopt new guidelines on the preclinical testing and rejig the rules on first-in-man studies.
Whether the BIA 10-2474 tragedy is followed by a similar reassessment remains to be seen.
TGN1412 reborn
The “elephant man” study was not the end of the road for TGN 1412. The drug was bought by Russia’s TheraMab and renamed TAB08.
TAB08 is being tested as a treatment for autoimmune disorders and – according to an article in the British Medical Journal (BMJ) – is due to enter Phase II trials having shown promise in a Phase I study carried out in London last year.
