17/03/08 - St George's Hospital Trial Judgement

[Nemotoday]

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17/03/08 - St George's Hospital Trial Judgement


The Board of Daval International Limited decided, in 2004, to terminate the first full-scale clinical trial of AIMSPRO at St George's Hospital, London. The Company had drawn on a broad range of Medical and Pharmaceutical opinion to form this important decision, which was necessitated by the sub-standard handling of trial medication at the hospital's pharmacy, with the possible risk to patient safety and data integrity. A complaint against the responsible hospital pharmacist was then lodged by Daval with the Royal Pharmaceutical Society of Great Britain.

The allegations of misconduct against the pharmacist were considered by the Investigating Committee on 4th March 2008 and it's judgement fully vindicates Daval's action in discontinuing this study, which was a two year placebo-controlled, double blind study of AIMSPRO as a potential palliative medication for Secondary Progressive Multiple Sclerosis.

The Committee reasoned that there were a number of factors and areas of responsibility which contributed to the failure of the clinical trial and that the pharmacist had failed to take control of his responsibilities by ensuring that appropriate standard operating procedures were in place.

Although this matter has taken some time to be resolved, Daval is pleased that the accusations which have been circulated by malicious and irresponsible parties since 2004, regarding the Company's motives in terminating the trial, have been satisfactorily quashed. As regards future human studies, Daval's interests are somewhat protected by the tighter Clinical Trial regulations in the United States, Europe and Australia that are now in force. It is re-stated that the company's over-riding priority, as it passes through the development phase of AIMSPRO, a complex biological medication, will be that of patient safety.

Daval adheres to the Code of Practice of the ABPI, of which it is a member.

Daval International Limited

17 March 2008