With over 540 patients, the combined U.S., Canadian and European trials form one
of the largest therapeutic programs ever conducted in HD.
Amarin Completes Target Patient Enrollment in North American
Phase III Trial of MiraxionT in Huntington's Disease -
http://www.amarincorp.com/pressrelease.cfm?id=147 and HDSA's website
LONDON, United Kingdom, June 29, 2006 -- Amarin Corporation plc (NASDAQ: AMRN)
today announced that it has successfully achieved target patient enrollment in
the North American Phase III clinical trial of Miraxion in Huntington's disease
(HD).
The target of three hundred randomized patients with HD in the TREND study,
which is being conducted by the Huntington Study Group (HSG) at 42 neurology
centers in the U.S. and Canada, has been met. The trial is evaluating the
effects of Miraxion compared to placebo using the Total Motor Score-4 (TMS-4)
subscale of the Unified Huntington's Disease Rating Scale (UHDRS).
It is hoped that patients treated with Miraxion at a dose of 2 grams per day (1
gram twice daily) for 6 months will demonstrate significant improvements in
their motor functioning as measured by TMS-4. Motor dysfunction is a prominent
and progressively deteriorating feature of HD, an ultimately fatal genetic
disease causing uncontrolled movements, loss of intellectual faculties,
emotional disturbances, psychosis and dementia. Currently, there are limited
treatment options for HD patients. There is no specifically approved treatment
in the US to prevent the symptoms of HD or to delay its progression. Earlier
studies of Miraxion showed encouraging improvements in motor function in HD
patients.
Rick Stewart, Chief Executive Officer of Amarin, commented; "Enrolling 300
individuals in this U.S. and Canadian Phase III trial is an enormous achievement
for Amarin. With over 540 patients, the combined U.S., Canadian and European
trials form one of the largest therapeutic programs ever conducted in HD. The
support and involvement of the HSG has been instrumental to our success in
meeting our enrollment target for such a large trial within nine months. We look
forward to completing the treatment phase of this trial by year end and eagerly
await its clinical result."
Miraxion has Orphan Drug designation in both the U.S. and Europe and has
Fast-Track designation from the FDA for review of the New Drug Application for
HD. The Phase III trials are being conducted under a Special Protocol Assessment
(SPA), a process under which the FDA provides evaluation and guidance on
clinical trial protocols for Phase III trials involving designated Orphan Drugs.
The Huntington Study Group (www.huntington-study-group.org), based at the
University of Rochester, is a non-profit group of leading physicians and other
health care providers from medical centres in the U.S., Canada, Europe and
Australia, experienced in the care of HD patients and dedicated to clinical
research in HD.
"The European Phase III clinical trial of Miraxion in HD was initiated three
months after the U.S. study and remains on schedule for full patient enrollment
by late summer," concluded Mr. Stewart.
[Non-text portions of this message have been removed]