3rd Oct 2007 08:45
AGI Therapeutics plc03 October 2007 AGI announces first patient dosed in Phase III trial of AGI-003, branded as RezularTM, in IBS-D Dublin, Ireland, October 3rd 2007 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces that the first patient in itspivotal Phase III study of AGI-003 (ARDIS) has been dosed. In conjunction withthis important milestone, AGI has branded AGI-003 as 'RezularTM' as it continuesto advance this product into the next phase of its development. As reported previously, ARDIS-1 is a Phase III trial in 1,200 patients (men andwomen) which is being conducted under an IND with the FDA. The study design hasbeen agreed with the FDA and if successful will be the first of 2 pivotalefficacy trials required for approval. ARDIS-1 is being conducted in over 130sites, with a majority of these in the USA. Patient enrolment is expected to continue into Q1 2008 and preliminaryindications of efficacy are expected in the second half of 2008. Patients who complete the 12 weeks of double blind treatment in ARDIS-1 areeligible to enrol into ARDIS-3, an open label safety study designed to provideone year safety data on up to 100 patients. Commenting, Dr. John Devane, CEO, said "Today's announcement of dosing the first patient in our pivotal Phase III trialis another major milestone for AGI. We believe ARDIS will confirm thetherapeutic benefit of Rezular in IBS-D, a major unmet medical need. We lookforward to keeping both our shareholders and the medical community informed onthe continuing success of this important product as it progresses towardsregulatory approval." 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 Notes to Editors: About RezularTM (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:
Potentially Ai