5th Feb 2008 07:00
AGI Therapeutics plc05 February 2008 AGI announces first patient dosed in Phase II trial of AGI-004 in chemotherapy-induced diarrhoea Dublin, Ireland, February 5th 2008 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces that the first patient has beendosed in its Phase II study of AGI-004 in the treatment of chemotherapy-induceddiarrhoea (CID). The current standard of care for CID patients usually involves multiple oraldaily doses of an opioid agent such as loperamide. However, many patients whoreceive loperamide continue to experience significant and debilitating diarrhoeawhich may require reduction, delay or even withdrawal of chemotherapy. AGI-004is a controlled release transdermal patch containing the nicotinic antagonistmecamylamine. The patch involves a new anti-diarrhoeal mechanism via selectiveblockade of enteric nicotinic acetylcholine receptors (nAChR) and offers asignificant advantage to current CID therapy via its convenient, once-dailytransdermal form. AGI previously reported data demonstrating a statistically significantimprovement in stool consistency in patients with functional diarrhoea. ThePhase II study is a randomised, double-blind, placebo-controlled evaluation ofAGI-004 in cancer patients experiencing National Cancer Institute (NCI) grade 1or 2 CID. Dr. John Devane, CEO of AGI, commented; "We believe AGI-004 has the potential toaddress a significant need for a more effective anti-diarrhoeal therapy forpatients undergoing chemotherapy and are very encouraged by the initiation ofdosing in this study population. We are pleased to see continued progress ofour product pipeline and, in addition to the pivotal Phase III programme forRezularTM in IBS-D, we look forward to further developments in our Phase IIprogrammes during the course of 2008." 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 AGI-004 and chemotherapy-induced diarrheoa (CID) AGI-004 is a controlled release transdermal patch containing mecamylaminedesigned for once-daily administration. AGI-004 is the subject of a number ofpending patent applications, the first of which was recently granted in theEuropean patent office (EP 1603544). Previously, AGI reported the results of a Phase II clinical study in patientswith functional diarrhoea. This study was designed to investigate theanti-diarrhoeal profile of AGI-004 and identify clinical signals which wouldinform further clinical development. Data from this pilot study demonstratedthat AGI-004 has a beneficial effect on certain diarrhoea-related symptoms,particularly stool consistency. Based on these clinical data, the mechanism ofaction of AGI-004 and the pathophysiology of certain non-functional diarrhoeaconditions, the Company determined that AGI-004 may be effective in treatingdiarrhoea-related symptoms in conditions such as chemotherapy-induced diarrhoea(CID). CID is a prevalent and severe toxicity associated with cancer chemotherapytreatment and occurs in up to 50% of patients receiving chemotherapy and canaffect up to 80% of patients receiving certain chemotherapy regimens. CID mayrange from troublesome (grade 1) to life-threatening (grade 4). CID cannegatively impact a patient's health to the point that they are unable totolerate their prescribed chemotherapy, commonly leading to delay or reductionin treatment which may diminish the effect of treatment. Loperamide is thecurrent drug of choice for the management of mild to moderate CID, but islimited in terms of its effectiveness and dosing flexibility, and there arecurrently few effective alternative therapies available. AGI-004, a low-dose controlled release form of mecamylamine, is a potent,non-competitive specific antagonist at nicotinic Acetylcholine receptors(nAChR). More specifically, AGI-004 has been shown to be selectively active oncertain nAChR sub-types which are the predominant form found on enteric neurons,where nAChR is known to regulate a range of gut functions, including modulationof secretory and motility effects. AGI-004 is formulated in a proprietarycontrolled release transdermal patch which can be administered one-daily. The current Phase II study is a randomised, prospective, multi-centre,double-blind, placebo-controlled, balanced, parallel-group trial in cancerpatients who are experiencing grade 1 or 2 CID. Patients will be randomlyallocated to active treatment or placebo. Treatment will be initiated 24 hoursprior to chemotherapy. Patients will continue to self-administer AGI-004 orplacebo patches once daily during and after chemotherapy for the duration of thecycle. Patients will be allowed free access to loperamide or other appropriatemedications on a rescue basis for the duration of any active episodes ofdiarrhoea. Treatment with AGI-004 or placebo will be for two consecutive cyclesof chemotherapy. The dose of mecamylamine will be escalated over the two cycles. 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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