SOURCE: AGI Therapeutics plc

October 08, 2007 04:28 ET

AGI Therapeutics plc announces Research Update

Dublin, Ireland--(Marketwire - October 8, 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™(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.


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.

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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.

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