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Amarin Ethyl-EPA (Miraxion) Study -

Huntington Study Group and the European Huntington’s Disease Network Announce Preliminary Results of Two Phase III Studies of Ethyl-EPA (Miraxion) for the Treatment of Huntington Disease

Rochester, New York and Ulm, Germany – April 25, 2007
The Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN) announce the preliminary results of two phase III studies of Ethyl-EPA (Miraxion), an omega-3 fatty acid, for people with Huntington´s Disease. These clinical trials were conducted in North America by the HSG, and in Europe by EHDN.

Please find the official press release of Amarin Neuroscience Ltd. on the Amarin web site. After accepting the disclaimer click on 'News & Press Releases' in the menu on the left hand side, the press release is posted on 24-Apr-2007. Information for study participants. Further information for investigators (login required).
Neither study showed a statistically significant differences in the pre-specified primary or secondary endpoints between patients receiving ethyl-EPA (one gram twice daily) or placebo for 6 months.
Huntington disease (HD) is an inherited disease affecting the brain that usually begins between the ages of 30 to 50, and includes motor, cognitive and behavioral symptoms and signs. About 30,000 people living in North America and approximately 38,000 people in Europe are directly affected by HD, and more than 300,000 people are immediately at risk for having inherited the altered gene that causes the disease. While there are medications to help relieve some disease symptoms, there are no treatments to slow the progression of this fatal illness.
Ethyl-EPA is an omega-3 fatty acid commonly found in fish oil. Research physicians at 41 North American sites of the HSG evaluated 316 research participants in the 6-month TREND-HD study. The primary outcome measure was Total Motor Score-4 (TMS-4), a subset of the Unified Huntington Disease Rating Scale, designed to assess the degree of motor impairment in people with Huntington disease. There was no significant benefit of ethyl-EPA on the TMS-4 nor were there any significant safety concerns.
In the European study, research physicians in 27 sites of the EHDN evaluated 290 research participants in a 6-month study. The primary outcome was also the TMS-4.  No significant benefit of ethyl-EPA on the TMS-4 was found nor was there evidence in the preliminary analysis of any major safety concern. In both studies, ethyl-EPA appeared to be well-tolerated.
Ira Shoulson, the HSG Principal Investigator said 'We are disappointed by the preliminary results of these studies but need to examine the findings in more detail.  We are grateful for the commitment of our research participants, and are proud of the high-quality data obtained in the trials. We remain committed to investigating experimental treatments that will make a difference in the lives of those affected by Huntington disease.'
Bernhard Landwehrmeyer, the EHDN Principal Investigator said 'The Ethyl-EPA trials in North America and Europe combined enrolled the largest number of research participants in any Huntington disease therapeutic trial to date and provided clear and unequivocal answers, although not the answers we hoped for. We are disappointed that no novel treatment option for patients affected with Huntington disease emerged from these large studies. Clearly there is a need for further analysis to understand why the results obtained differed from those of an earlier smaller study. EHDN will continue to support and conduct clinical studies and research projects that clarify conclusively what treatments benefit people affected by Huntington disease.'
In the coming weeks and months, the HSG and EHDN will conduct additional in-depth analyses and disseminate these results to research participants, investigators, the HD community, and the scientific community.  
The Huntington Study Group is a non-profit cooperative group of Huntington’s disease experts from medical centers in the United States, Canada, Europe and Australia who are dedicated to improving treatment for persons affected by Huntington’s disease. For more information, please visit our website.
The European Huntington’s Disease Network is an independent, non-profit network of clinicians, scientists and family members that aims to advance knowledge of Huntington's disease ("HD"). The EHDN supports scientific and clinical efforts to develop and test therapeutic interventions that will improve the quality of life of people with HD.  EHDN serves as a platform for clinicians, scientists and organizations for families affected by HD to collaborate in support of preclinical and clinical research on HD.

For further information, please contact:

Ira Shoulson, MD
Leslie Briner
University of Rochester
Phone: +1 585 273 4147        

Bernhard Landwehrmeyer, MD
Jamie Levey
European Huntington’s Disease Network
Phone: +49 731 500 63101