英国医薬品庁（ロンドンでの第 I 相試験）

今回の英国Phase I 施設での出来事で、開発会社、臨床試験受託会社の医療機関、動物実験施設、製造会社のいずれにも問題は見られなかったようだ。
“Cytokine Release Syndrome”という人間の体内で起こった免疫反応が原因なのか？

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■英国医薬品庁（MHRA：Medicines and Healthcare Products Regulatory Agency）→http://www.mhra.gov.uk

Press release Date: 05 Apr 2006 Time: 15:15 Subject: Clinical trial suspension report Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 The MHRA has today released its interim report into the adverse incidents which occurred on 13th March 2006 during the clinical trials of TGN1412 (see report below). It has found no evidence to suggest that there was any problem with the manufacturing of the product which was given to the trial volunteers – it appears not to have been contaminated, or to have contained anything other than the correct ingredients. Neither have we found anything in the way the trial was run which contributed to the adverse reactions experienced by the volunteers – it was run according to the agreed protocol, and the correct dose of the product was given to the patients. “There are still further tests planned and until these are complete we cannot be firm about our conclusions.  However, if these findings were to be confirmed, it would indicate that this product showed a pharmacological effect in man which was not seen in pre-clinical tests in animals at much higher doses.  The Secretary of State for Health has therefore agreed to establish a group of leading international experts in the field to examine the issue further. The Group will need to review the evidence from the TGN1412 case and consider what necessary changes to clinical trials may be required”, says MHRA Chief Executive Professor Kent Woods. Press conference held today at MHRA Head Office From l to r: Simon Gregor, Director of Communications; Professor Kent Woods, MHRA Chief Executive; Sara Coakley, Media Relations Manager. Notes to Editor 1.See also interim report. 2.Full copy of the clinical trial application available below. Download documents: Investigations into adverse incidents during clinical trials of TGN1412: interim report Latest findings on clinical trial suspension: press release TGN1412 clinical trial application: release of information cover note TGN1412 clinical trial: assessment report TGN1412 clinical trial: investigational medicinal product dossier TGN1412 clinical trial: investigator's brochure TGN1412 clinical trial: protocol

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