Dublin, Ireland,5th February 2008
AGI announces first patient dosed in Phase II trial
of AGI-004 in chemotherapy-induced diarrhoea
AGI Therapeutics plc ("AGI" or the "Company") (AIM,
IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal
drug products, today announces that the first patient has been dosed in
its Phase II study of AGI-004 in the treatment of chemotherapy-induced
diarrhoea (CID).
The current standard of care for CID patients usually involves multiple oral daily doses of an opioid agent such as loperamide. However, many patients who receive loperamide continue to experience significant and debilitating diarrhoea which may require reduction, delay or even withdrawal of chemotherapy. AGI-004 is a controlled release transdermal patch containing the nicotinic antagonist mecamylamine. The patch involves a new anti-diarrhoeal mechanism via selective blockade of enteric nicotinic acetylcholine receptors (nAChR) and offers a significant advantage to current CID therapy via its convenient, once-daily transdermal form.
AGI previously reported data demonstrating a statistically significant improvement in stool consistency in patients with functional diarrhoea. The Phase II study is a randomised, double-blind, placebo-controlled evaluation of AGI-004 in cancer patients experiencing National Cancer Institute (NCI) grade 1 or 2 CID.
Dr. John Devane, CEO of AGI, commented; "We believe AGI-004 has the potential to address a significant need for a more effective anti-diarrhoeal therapy for patients undergoing chemotherapy and are very encouraged by the initiation of dosing in this study population. We are pleased to see continued progress of our product pipeline and, in addition to the pivotal Phase III programme for RezularTM in IBS-D, we look forward to further developments in our Phase II programmes during the course of 2008.
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Deborah Scott/Lara Mott
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Aisling Garvey
Tel: +353 1 663 3607
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
Notes to Editors:
About AGI-004 and chemotherapy-induced diarrheoa (CID)
AGI-004 is a controlled release transdermal patch containing mecamylamine designed for once-daily administration. AGI-004 is the subject of a number of pending patent applications, the first of which was recently granted in the European patent office (EP 1603544).
Previously, AGI reported the results of a Phase II clinical study in patients with functional diarrhoea. This study was designed to investigate the anti-diarrhoeal profile of AGI-004 and identify clinical signals which would inform further clinical development. Data from this pilot study demonstrated that AGI-004 has a beneficial effect on certain diarrhoea-related symptoms, particularly stool consistency. Based on these clinical data, the mechanism of action of AGI-004 and the pathophysiology of certain non-functional diarrhoea conditions, the Company determined that AGI-004 may be effective in treating diarrhoea-related symptoms in conditions such as chemotherapy-induced diarrhoea (CID).
CID is a prevalent and severe toxicity associated with cancer chemotherapy treatment and occurs in up to 50% of patients receiving chemotherapy and can affect up to 80% of patients receiving certain chemotherapy regimens. CID may range from troublesome (grade 1) to life-threatening (grade 4). CID can negatively impact a patient's health to the point that they are unable to tolerate their prescribed chemotherapy, commonly leading to delay or reduction in treatment which may diminish the effect of treatment. Loperamide is the current drug of choice for the management of mild to moderate CID, but is limited in terms of its effectiveness and dosing flexibility, and there are currently 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 on certain nAChR sub-types which are the predominant form found on enteric neurons, where nAChR is known to regulate a range of gut functions, including modulation of secretory and motility effects. AGI-004 is formulated in a proprietary controlled 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 cancer patients who are experiencing grade 1 or 2 CID. Patients will be randomly allocated to active treatment or placebo. Treatment will be initiated 24 hours prior to chemotherapy. Patients will continue to self-administer AGI-004 or placebo patches once daily during and after chemotherapy for the duration of the cycle. Patients will be allowed free access to loperamide or other appropriate medications on a rescue basis for the duration of any active episodes of diarrhoea. Treatment with AGI-004 or placebo will be for two consecutive cycles of chemotherapy. The dose of mecamylamine will be escalated over the two cycles.
About AGI
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 the 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, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. 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 six 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. These product candidates are all in clinical development, including five Phase II trials.
AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.
Statements contained within this press release may contain forward-looking comments that 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.