8th Oct 2007 07:00
AGI Therapeutics plc08 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 ongastrointestinal drug products, today announces the presentation of Phase IIclinical results of Rezular, AGI's arverapamil (AGI-003) product, at theAmerican College of Gastroenterology Scientific Meeting being held inPhiladelphia. Professor Eamonn Quigley, the principal investigator for the study will presentthe data as an oral presentation at 8.30a.m. on Wednesday Oct 17, 2007. Rezularis 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 torandomise and dose patients. Rezular (AGI's arverapamil (AGI-003) product) is a single enantiomer of racemicverapamil, a drug that has been administered to patients for 35 years. Rezularrepresents a new first-in-class compound for IBS-D. It has a unique triplemechanism of action combining affinity at L-type calcium channels with 5-HT2band melatonin (MT1) receptor binding. In the Phase II study Rezular provided a significant therapeutic benefit overplacebo in terms of patient global impression of IBS symptoms (19.4%) and reliefof pain/discomfort (13.1%). In addition, patients on Rezular had significantimprovement and obvious dose-response in various secondary end-points includingthe Bristol stool scale and an IBS-specific quality of life survey. Patientstreated with Rezular tolerated all doses of the compound well with side effectstypical 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 communityis timely given that patient randomisation in ARDIS-1 commenced on October 2nd.It is important that the gastroenterology community has the opportunity to notonly see the robust therapeutic profile of Rezular but also to understand theunique mechanism of action that this compound offers. IBS is a complex conditionand by harnessing a number of complementary activities into a single agent AGI'scompound has significant therapeutic benefit and minimises the potential safetyrisks from the more traditional highly potent single mechanism drugs." Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7269 7182Deborah Scott/Lara Mott Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey Piper Jaffray Limited Tel: +44 (0) 20 3142 8700Neil MackisonWill Carnwath Davy Tel: +353 (1) 614 8761John 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 containsarverapamil, a single enantiomer moiety of the racemic drug verapamil. Unlikethe currently available commercial forms of racemic verapamil (a mixture of twoenantiomers), Rezular shows a dominant activity in treating the symptoms ofIBS-D without the traditional cardiovascular actions of the racemic drug. Theefficacy and safety of Rezular in IBS patients has already been established in aPhase II trial, the preliminary results of which were reported by the Company in2006. About ARDIS ARDIS represents AGI's Phase III programme for Rezular (AGI-003) in thetreatment of IBS-D and consists of three pivotal studies. ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel group, PhaseIII 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 12weeks 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 randomise1,200 patients into ARDIS-1. ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted inIBS-D patients upon completion of ARDIS-1. ARDIS-3 is an open-label safety study designed to capture 1 year extended safetyin approximately 100 patients on continuous Rezular therapy. About IBS-D Irritable bowel syndrome (IBS) is a functional disorder that comprises a clusterof gastrointestinal symptoms which are likely to be life long and which affectbetween 10% and 20% of the population in developed markets. IBS remains themost common diagnosis made by gastroenterologists and can lead to a substantialreduction in patients' quality of life, accompanied by considerablesocio-economic and psychological consequences. Altered intestinal motility is amajor component of IBS and patients are diagnosed and sub-typed according totheir predominant symptom of bowel disturbance. Diarrhoea-predominant irritablebowel 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 fewsafe and effective therapeutic options available to these patients. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (GI)diseases and disorders. AGI's common shares are listed on the AlternativeInvestment Market of the London Stock Exchange (AIM) and on the Irish EnterpriseExchange of the Irish Stock Market (IEX) as AGI. The Company has a portfolio of product candidates derived from its KnownMolecular Entity (KME) approach to drug re-profiling and development. KME is are-profiling methodology used by the Company to identify existing therapeuticdrugs which typically have been marketed for a number of years, have establishedsafety profiles and can be developed for new clinical indications or withimproved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) anddiarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). TheCompany is targeting areas of the GI therapeutic drug products market for itsproduct candidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has five active clinical stage product candidates which are eitherisomers or new drug delivery formulations of existing approved drugs, and whichhave established safety and tolerability profiles in their currently approvedclinical indications. For further information please see www.agitherapeutics.com Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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