AMRN - Amarin to Commence Phase II Trial With AMR101 in Age Associated Memory Impairment
Thursday January 10, 6:30 am ET
LONDON, January 10 /PRNewswire-FirstCall/ -- Amarin Corporation plc (NASDAQ: AMRN - News) today announced that it has received the necessary regulatory and ethical approvals to commence a Phase IIa trial in Age Associated Memory Impairment (AAMI) with AMR101 (ultra-pure ethyl-EPA).
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The Phase IIa trial will be a randomized, double-blind, placebo-controlled study. The trial will enroll 96 patients with AAMI who will be randomized to receive 1, 2 or 4 grams of AMR101 or placebo twice daily over a six-week period. Efficacy will be assessed by a computerised battery of cognition tests designed by Cognitive Drug Research (CDR) Ltd, a world leader in the provision of innovative cognitive function assessment technology. The study is being conducted in the U.K. and patient recruitment is expected to commence shortly, with initial results expected in the second half of 2008.
Dr. Declan Doogan, Head of Research and Development at Amarin commented, "AMR101 has already demonstrated promising positive effects in classical preclinical models of memory and cognition. We are pleased to receive approval to commence this study with AMR101 and look forward to assessing its effects on AAMI, an area of growing medical concern in all developed nations with aging populations."
Amarin had previously announced positive results from a pre-clinical program in memory and cognition using AMR101, conducted in collaboration with Professor Marina Lynch, Department of Physiology, Institute of Neuroscience, Trinity College, Dublin.
About Age Associated Memory Impairment (AAMI)
AAMI is a recognized syndrome relating to memory changes associated with normal aging. AAMI is a common condition in individuals over 50 years of age. In the United States, it is estimated that approximately 40% of people aged 65 and above, or 16 million, have AAMI. It is characterized by gradual memory impairment (subjective memory decline and objective memory loss) with the absence of dementia. Individuals with AAMI have been shown to have a three-fold greater risk for development of dementia than individuals who do not meet AAMI criteria.
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