Dublin, Ireland--(Marketwire - October 8, 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 on
gastrointestinal drug products, today announces the presentation of Phase
II clinical results of Rezular, AGI's arverapamil (AGI-003) product, at
the American College of Gastroenterology Scientific Meeting being held in
Philadelphia.
Professor Eamonn Quigley, the principal investigator for the study will
present the data as an oral presentation at 8.30a.m. on Wednesday Oct 17,
2007. Rezular is 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 to randomise and dose patients.
Rezular (AGI's arverapamil (AGI-003) product) is a single enantiomer of
racemic verapamil, a drug that has been administered to patients for 35
years. Rezular represents a new first-in-class compound for IBS-D. It has
a unique triple mechanism of action combining affinity at L-type calcium
channels with 5-HT2b and melatonin (MT1) receptor binding.
In the Phase II study Rezular provided a significant therapeutic benefit
over placebo in terms of patient global impression of IBS symptoms
(19.4%) and relief of pain/discomfort (13.1%). In addition, patients on
Rezular had significant improvement and obvious dose-response in various
secondary end-points including the Bristol stool scale and an IBS-
specific quality of life survey. Patients treated with Rezular tolerated
all doses of the compound well with side effects typical 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
community is timely given that patient randomisation in ARDIS-1 commenced
on October 2nd. It is important that the gastroenterology community has
the opportunity to not only see the robust therapeutic profile of Rezular
but also to understand the unique mechanism of action that this compound
offers. IBS is a complex condition and by harnessing a number of
complementary activities into a single agent AGI's compound has
significant therapeutic benefit and minimises the potential safety
risks from the more traditional highly potent single mechanism drugs."
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 Rezular™(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
contains arverapamil, a single enantiomer moiety of the racemic drug
verapamil. Unlike the currently available commercial forms of racemic
verapamil (a mixture of two enantiomers), Rezular shows a dominant
activity in treating the symptoms of IBS-D without the traditional
cardiovascular actions of the racemic drug. The efficacy and safety of
Rezular in IBS patients has already been established in a Phase II trial,
the preliminary results of which were reported by the Company in 2006.
About ARDIS
ARDIS represents AGI's Phase III programme for Rezular (AGI-003) in the
treatment of IBS-D and consists of three pivotal studies.
ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel
group, Phase III 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 12 weeks 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 randomise 1,200 patients into
ARDIS-1.
ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted
in IBS-D patients upon completion of ARDIS-1.
ARDIS-3 is an open-label safety study designed to capture 1 year extended
safety in approximately 100 patients on continuous Rezular therapy.
About IBS-D
Irritable bowel syndrome (IBS) is a functional disorder that comprises a
cluster of gastrointestinal symptoms which are likely to be life long and
which affect between 10% and 20% of the population in developed markets.
IBS remains the most common diagnosis made by gastroenterologists and can
lead to a substantial reduction in patients' quality of life, accompanied
by considerable socio-economic and psychological consequences. Altered
intestinal motility is a major component of IBS and patients are
diagnosed and sub-typed according to their predominant symptom of bowel
disturbance. Diarrhoea-predominant irritable bowel 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 few safe and
effective therapeutic options available to these patients.
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
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