Dublin, Ireland–( EMWNews – April 2, 2008) –

    AGI announces key findings of clinical PK study of arbaclofen (AGI-006)

Dublin, Ireland, 2 April 2008 – AGI Therapeutics plc (“AGI” or the “Company”)

(AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal

drug products, today announces the key findings of a clinical study to assess

the pharmacokinetic profile of arbaclofen (AGI-006), which is being developed

for the treatment of gastroparesis, a significant gastric condition amongst

diabetics.

The pharmacokinetic study was conducted in healthy human volunteers and compared

the drug exposure profile of arbaclofen, under both fasted and fed conditions,

following a single oral administration of a 5mg dose. Arbaclofen contains the

purified R-isomer form of the previously approved drug baclofen (which is an

equal mixture of the S- and R-isomers). In addition, this study compared the

drug exposure of arbaclofen (5mg), in terms of both the S- and R-isomer forms of

baclofen, with a single 10mg oral dose of Lioresal® (a marketed form of

racemic baclofen).

The key findings were:

     

(1)  There were no detectable S-isomer levels following arbaclofen 

     administration and thus no evidence of any interconversion of arbaclofen

     (R-isomer) to S-isomer in vivo.  The S-isomer is believed to partly 

     counteract the activity of the R-isomer, the critical isomer for the 

     beneficial effects of AGI-006 on gut function, and also contribute unwanted 

     side effects through its own actions and effects.



(2)  Following arbaclofen administration, approximately 80% of the administered

     dose was recovered in the urine in unchanged form.  The high recovery of

     unchanged R-isomer in the urine following arbaclofen administration 

     indicates there is no significant effect of hepatic metabolism on the 

     kinetics of arbaclofen.



(3)  There was comparable plasma exposure of R-isomer from 5mg of arbaclofen

     compared to 10 mg of Lioresal, confirming that the exposure to the R-isomer 

     is no greater following arbaclofen administration when compared with 

     equivalent doses of an approved and marketed form of racemic baclofen.



(4)  The rate of drug exposure (expressed as time to peak plasma concentration,

     or "Tmax") and the extent of drug exposure (expressed in terms of both peak

     plasma concentration, or "Cmax", and area under the plasma concentration 

     curve, or "AUC") following arbaclofen administration were only modestly 

     reduced by food.  This demonstrates that acceptable drug exposure can be 

     achieved with AGI-006 in situations where gastric emptying is delayed (in 

     this case food-induced), which is a key feature of the targeted 

     gastroparesis indication.

Commenting on the results Dr John Devane said “These findings have important

implications for the further clinical development of arbaclofen. We can now

proceed in the knowledge that there will be no exposure to the S-isomer

following administration of the purified R-isomer form contained in AGI-006. In

addition, confirmation that the in vivo exposure to the R-isomer following

arbaclofen administration is no greater than is seen with marketed racemic

baclofen will support our 505(b)2 NDA development strategy and the associated

cross-referencing of the pre-clinical and clinical safety history available on

racemic baclofen.”

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 the study

The pharmacokinetic study was a single-dose, open-label, randomized, three-way

crossover study in nine healthy subjects (4 males, 5 females). The treatments

were arbaclofen/AGI-006 (5mg) administered under fasting and fed conditions and

Lioresal® (10mg) administered under fasting conditions. Lioresal is an

FDA-approved form of racemic baclofen which is used to treat CNS disorders.

Blood samples were taken periodically up to 24 hours after each administration

and there was also a cumulative 24 hour collection of urine. Plasma and urine

concentrations of the R- and S-isomers of baclofen were measured using a

validated Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS)

method. All treatments in the study were well tolerated.

About arbaclofen (AGI-006)

Arbaclofen is our product candidate for the treatment of gastroparesis and for

dyspeptic conditions such as functional dyspepsia. Gastroparesis is a

significant GI disorder among diabetic patients and affects up to 20% of Type I

and 30% of Type II diabetics. Current drug therapy for gastroparesis is limited

and there is a significant market opportunity for new safe and effective

products. Arbaclofen is an oral dosage form of the predominant

pharmacologically active r-isomer of baclofen.

About gastroparesis

Gastroparesis is a gastric motility disorder where there is delayed gastric

emptying and the condition is usually chronic. The primary known cause of

gastroparesis is diabetes and the condition is frequently referred to as ‘

diabetic gastroparesis’. In diabetic patients (both Types I and II),

gastroparesis is caused by prolonged elevated serum glucose levels resulting in

vagal nerve damage, which in turn leads to impaired gastric motility and

emptying. Gastroparesis is estimated to affect up to 30% of Type I and 20% of

Type II diabetics. There are an estimated 2.5 million diabetic gastroparesis

patients in the US and 1.5 million in Europe, while the incidence is expected to

rise as the diabetic population continues to increases across the globe.

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