The results showed a statistically significant difference in the primary endpoint of reducing the incidence of patient-recorded diarrhoea (response defined as less than 4 bowel movements per day). This was observed at the higher of two doses of AGI-004 when compared with placebo. The robust response for the higher dose of AGI-004 was further supported by a statistically significant difference in the secondary endpoint of patient recorded severity of diarrhoea, while positive trends were observed in the other secondary measurement of reduction in the use of rescue anti-diarrhoeal medications. Non-significant benefit in the primary endpoint was also observed with the lower dose and, when diarrhoea was rated by the physician using the National Cancer Institute (NCI) grading system, both doses demonstrated positive improvements. Similarly, positive trends were also observed for the higher dose in the co-primary endpoint of reducing the number of bowel movements per day.

While some benefit was seen with the lower dose in treating individual symptoms, the overall results are consistent with a dose response effect. In addition to the full cycle results described above, an analysis of acute (first day of chemotherapy) data, confirmed the robust control of diarrhoea at the higher dose. AGI-004 treatment was well tolerated across both doses and there were no drug-related serious adverse events.

Commenting on the results of the study, Dr. John Devane, CEO, said ''We are pleased with the outcome of this study which we believe supports the continued development of AGI-004 as a novel anti-diarrhoeal agent. CID is a common and debilitating side effect which affects many patients undergoing chemotherapy. Although designed as an exploratory study, we observed a strong signal of efficacy for AGI-004 across multiple measurements of diarrhoea, in particular with the higher dose used in the study. The development of AGI-004 in a convenient transdermal patch, which can reduce the occurrence of diarrhoea in chemotherapy patients, offers a significant therapeutic advantage over current standard of care.''

Contact Information:

AGI Therapeutics plc. Tel: +353 1 449 3254 David Kelly, Chief Financial Officer

FD - UK Tel: +44 (0) 20 7269 7205 Jonathan Birt/John Dineen

FD - Ireland Tel: +353 1 663 3607 Niamh Lyons

Piper Jaffray Limited Tel: +44 (0) 20 3142 8700 Neil Mackison Will Carnwath

Davy Tel: +353 1 614 8761 John Frain

For further information please see http://www.agitherapeutics.com.

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