AGI AGI

RNS Number:2314F
AGI Therapeutics plc
08 October 2007


 AGI's Rezular(TM)Phase II clinical data to be presented at American College of
                      Gastroenterology Scientific Meeting

                   -- 8.30a.m., Wednesday October 17, 2007 --

Dublin, Ireland, October 8th 2007 - AGI Therapeutics plc ("AGI" or the
"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on
gastrointestinal drug products, today announces the presentation of Phase II
clinical results of Rezular, AGI's arverapamil (AGI-003) product, at the
American College of Gastroenterology Scientific Meeting being held in
Philadelphia.

Professor Eamonn Quigley, the principal investigator for the study will present
the data as an oral presentation at 8.30a.m. on Wednesday Oct 17, 2007. Rezular
is currently in Phase III clinical development for IBS-D and its first efficacy/
safety study (ARDIS-1), which plans to treat 1200 patients, has begun to
randomise and dose patients.

Rezular (AGI's arverapamil (AGI-003) product) is a single enantiomer of racemic
verapamil, a drug that has been administered to patients for 35 years. Rezular
represents a new first-in-class compound for IBS-D. It has a unique triple
mechanism of action combining affinity at L-type calcium channels with 5-HT2b
and melatonin (MT1) receptor binding.

In the Phase II study Rezular provided a significant therapeutic benefit over
placebo in terms of patient global impression of IBS symptoms (19.4%) and relief
of pain/discomfort (13.1%). In addition, patients on Rezular had significant
improvement and obvious dose-response in various secondary end-points including
the Bristol stool scale and an IBS-specific quality of life survey. Patients
treated with Rezular tolerated all doses of the compound well with side effects
typical of racemic verapamil and no serious adverse effects occurring.

Commenting, Dr. John Devane, CEO of AGI, said

"The presentation of our Phase II data to the wider gastroenterology community
is timely given that patient randomisation in ARDIS-1 commenced on October 2nd.
It is important that the gastroenterology community has the opportunity to not
only see the robust therapeutic profile of Rezular but also to understand the
unique mechanism of action that this compound offers. IBS is a complex condition
and by harnessing a number of complementary activities into a single agent AGI's
compound has significant therapeutic benefit and minimises the potential safety
risks from the more traditional highly potent single mechanism drugs."


Contact Information:

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

Financial Dynamics - UK                             Tel: +44 (0) 20 7269 7182
Deborah Scott/Lara Mott

Financial Dynamics - Ireland                        Tel: +353 1 663 3607
Aisling Garvey

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

Davy                                                Tel: +353 (1) 614 8761
John Frain



Notes to Editors:

About Rezular(TM)(AGI-003)

Rezular (AGI-003) is an orally administered triple-action intestinal regulator,
a first-in-class mechanism for the treatment of IBS-D. Rezular contains
arverapamil, a single enantiomer moiety of the racemic drug verapamil. Unlike
the currently available commercial forms of racemic verapamil (a mixture of two
enantiomers), Rezular shows a dominant activity in treating the symptoms of
IBS-D without the traditional cardiovascular actions of the racemic drug. The
efficacy and safety of Rezular in IBS patients has already been established in a
Phase II trial, the preliminary results of which were reported by the Company in
2006.

About ARDIS

ARDIS represents AGI's Phase III programme for Rezular (AGI-003) in the
treatment of IBS-D and consists of three pivotal studies.

ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel group, Phase
III study in IBS-D patients (both men and women). There are four treatment arms
(placebo and three dose levels of Rezular) and patients will be treated for 12
weeks of double-blind therapy. At the end of double-blind therapy in ARDIS-1,
patients will become eligible to enrol into ARDIS-3. It is planned to randomise
1,200 patients into ARDIS-1.

ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted in
IBS-D patients upon completion of ARDIS-1.

ARDIS-3 is an open-label safety study designed to capture 1 year extended safety
in approximately 100 patients on continuous Rezular  therapy.

About IBS-D

Irritable bowel syndrome (IBS) is a functional disorder that comprises a cluster
of gastrointestinal symptoms which are likely to be life long and which affect
between 10% and 20% of the population in developed markets.  IBS remains the
most common diagnosis made by gastroenterologists and can lead to a substantial
reduction in patients' quality of life, accompanied by considerable
socio-economic and psychological consequences. Altered intestinal motility is a
major component of IBS and patients are diagnosed and sub-typed according to
their predominant symptom of bowel disturbance.  Diarrhoea-predominant irritable
bowel syndrome (IBS-D) is estimated to occur in one-third of all IBS patients.
IBS-D represents a significant unmet medical need as there are currently few
safe and effective therapeutic options available to these patients.

About AGI Therapeutics plc

AGI is a speciality pharmaceutical company which is focused on the development
and commercialisation of differentiated drug products for gastrointestinal (GI)
diseases and disorders. AGI's common shares are listed on the Alternative
Investment Market of the London Stock Exchange (AIM) and on the Irish Enterprise
Exchange of the Irish Stock Market (IEX) as AGI.

The Company has a portfolio of product candidates derived from its Known
Molecular Entity (KME) approach to drug re-profiling and development. KME is a
re-profiling methodology used by the Company to identify existing therapeutic
drugs which typically have been marketed for a number of years, have established
safety profiles and can be developed for new clinical indications or with
improved profiles in their existing clinical indications. In this way, the
Company seeks to reduce the risk, time and cost of new product development as
compared to the development of new chemical entities.

AGI is developing a range of product candidates to treat a variety of prevalent
GI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,
gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) and
diarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). The
Company is targeting areas of the GI therapeutic drug products market for its
product candidates where there are currently unmet medical needs or where the
effectiveness of existing drug therapies can be further improved.

The Company has five active clinical stage product candidates which are either
isomers or new drug delivery formulations of existing approved drugs, and which
have established safety and tolerability profiles in their currently approved
clinical indications.

For further information please see www.agitherapeutics.com

Statements contained within this press release may contain forward-looking
comments which involve risks and uncertainties that may cause actual results to
vary from those contained in the forward-looking statements. In some cases, you
can identify such forward-looking statements by terminology such as 'may', '
will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', '
estimates', 'predicts', 'potential', or 'continue'. Predictions and
forward-looking references in this press release are subject to the satisfactory
progress of research which is, by nature, unpredictable. Forward projections
reflect management's best estimates based on information available at the time
of issue.


                      This information is provided by RNS
            The company news service from the London Stock Exchange
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