Emails to & from Dr Brock of Great Ormond Street Hospital

Date: Thu, 05 Jan 2006 11:27:17 0000
From:”Penelope Brock”
Subject: Re: Bobby Wright

Dear Kevin,

The phase I study in Europe has closed to entry. No patients were
entered in the UK as we did not get MHRA or MREC approval inspite of an
extensive application process. We are awaiting the results from Europe
and will then use these to try to get MHRA approval for its randomised
use in the current phase III trial as planned in the UK.

Getting new medication through the authorities from an academic
centre has become very difficult indeed.I have been assured of full
support from the UKCCSG and the CRUK to prepare the application but am
expecting a hard and frustrating time ahead. I go to the UKCCSG
tomorrow to start negotiations. It could take a year.

With best wishes,

Penelope Brock

> KEVIN WRIGHT <> 29/08/2005 23:48:02 >

Dear Dr Brock,

Thanks for your reply. Would you be so kind as to forward the letter for parents to me? also, I have an information sheet for parent/guardian dated August 2002 that states that the third randomisation (R2) is immunotherapy versus none. Why is this taking so long? has there been a problem which has set this treatment back? are you hoping for phase 111 trials early in 2006? MSKCC have safely given over 5000 infusions of CF8 since 1996 with no serious side effects so the delay in the UK is perplexing to say the least. Thank you so very much for your time for us. The Wright family. Reply 10 days later-

Date: Wed, 07 Sep 2005 18:17:09 +0100 From: “Penelope Brock” <>
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To: Subject: Re: Bobby Wright Dear Mr Wright, I asked someone at the UKCCSG to forward the letter the day you wrote but it does not appear to have happened . I apologise for the delay. Attached is the letter which you should have been given at the time of starting the trial. The delay for the European group has been most unfortunate and it has been to do with producing enough antibody from the American clone for all the patients in the study. The first attempt by Bioinvent failed. Polymmun have now succeeded but had to change the methodology and produce the antibody in ovarian hamster cells. Due to this change we are now obliged to carry out a phase I bridging study before we can use the drug in a phase III study. The rules in Europe since May 1st 2004 have become very strict. It has been most frustrating for all of the countries involved. The centres who will run the phase I are awaiting final approval and then hopefully , depending on how many patients need to get the drug in phase I , which is regulated by the toxicity, the minimum is 3 per dose level, eg 9. As soon as this is complete we can start the ethics procedure for the phase III. I cannot say exactly how long it all will take. With best wishes, Dr Penelope Brock