Delay to the ATTeST trial
As some people will be aware, there has been a delay in recruiting people onto the ATTeST trial of the EryDex system, which was due to start at Nottingham earlier this year.
All the organisational issues involved in setting up the trial centre which we reported last year have been resolved and a Clinical Research Fellow, Dr Jeyanthi Rangaraj, appointed. Some 20 families have been in contact with the team and 16 children identified for initial screening, which was due to start in January.
However the US Food and Drug Agency has put a temporary stop on recruitment to the trial allowing only patients already enrolled to continue treatment. The reason for this was that some samples taken prior to infusion into patients were found on testing to be contaminated by some bacteria.
To be clear, it was only samples for testing that were involved, and only a few of these. There is no suggestion that any of the participants could be affected, and indeed children already on the trial are being allowed to continue. However, until the issue is fully understood and resolved, the authorities have insisted that all new recruitment be suspended.
The trial organisers have cooperated fully with the authorities. They have investigated thoroughly and reported back with proposals to modify the sampling procedures. However, they are still waiting for permission to proceed with recruitment.
We understand and share the frustration that many families will feel. While the outcome of any clinical trial can never be known beforehand, we are all very keen to know whether or not this treatment really can improve the neurological symptoms of A-T effectively and safely.
The A-T Society’s chief executive William Davis said: “It needs no saying that the safety of participants in the trial must be our number one priority. However there is no suggestion that the Erydex System itself is affected or that there is any risk to those using it. As time is of the essence for people living with AT, we would urge the authorities to come to a rapid conclusion and, we very much hope, let the trial proceed as planned.”
If you have any further questions about the trial, please contact the A-T Society on 01582 760733 or email email@example.com.