Navigation Links
Amarin Announces Completion of Comprehensive Data Analysis From Phase III Huntington's Disease Program
Date:11/19/2007

LONDON, November 19 /PRNewswire-FirstCall/ -- Amarin Corporation plc (NASDAQ: AMRN) ("Amarin" or "Company") today announced that management has met with the U.S. Food and Drug Administration (FDA) following the completion of a comprehensive data review from its large-scale Phase III studies of Miraxion to treat Huntington's disease (HD). The FDA indicated that one additional Phase III trial demonstrating robust results, in conjunction with the confirmatory evidence from the existing clinical data, may be sufficient clinical data to support a New Drug Application.

Rick Stewart, Chief Executive Officer of Amarin, commented "We are pleased with the results of the comprehensive clinical data review and are encouraged by the outcome of our recent dialogue with the FDA. We are now in discussions with the Huntington Study Group to determine the optimal design of such a single Phase III trial. We are also considering whether Amarin will conduct this study itself or seek a collaborative partner with which to advance Miraxion in Huntington's disease."

Since the most recent update on Miraxion to treat HD on August 1, 2007, the Company has continued a comprehensive analysis of all clinical data with its advisors. This additional analysis supports the preliminary findings, suggesting a clinical benefit from a longer treatment period for Miraxion.

Positive 12-month results from U.S. Phase III Trial (TREND-HD)

The TREND-HD trial, conducted by the Huntington Study Group in the U.S. and Canada in 316 patients, was a 6-month, double-blind placebo controlled study followed by a further 6-month extension period where all patients received 2 grams per day of Miraxion. The primary endpoint was the 6-month change in
'/>"/>

SOURCE Amarin Corporation Plc
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
2. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
3. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
4. HEI, Inc. Announces Sale of RFID Division Assets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
8. Brooke Franchise Corporation Announces Selected July Results
9. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
11. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2008)...Aug. 29 /PRNewswire-USNewswire/ -- The Holiday,Sta...aul suburb of Eagan,will reduce the price of E85 b...m 11 a.m. until 1 p.m. The promotion is timed to o...d the fleet of flexible fuel vehicles,General Moto... There is a,15 gallon limit per flexible fuel vehi...
(Date:8/29/2008)... caused chromosomal change that raises odds for ma...9 (HealthDay News) -- Some Japanese survivors of t...d Nagasaki experienced key genetic changes that ma...er, new research indicates. , Papillary thyroid...genetic mutation involving the so-called BRAF gene...
(Date:8/29/2008)..., Aug. 29 /PRNewswire/ -- In response to recent ne...ic wasting disease (CWD),members of the deer farm..., With hunting season fast approaching, the tragi...r on a Kent County farm understandably has,created...er farmers across,the great state of Michigan. The...
(Date:8/29/2008)...Opens Market to More Than 30 European Countries, ...nc. announced today,that it has successfully compl... and the Medical Device Directive (for most Europe...oveted CE Mark -- or Conformite Europeene Mark,-- ... expands Hoana,s,patient safety reach to include m...
Breaking Medicine News(10 mins):Health News:An 'Unconventional' Fuel at an Unbelievable Price: Minnesota Station Cuts Cost of E85 by $1 Per Gallon 2Health News:Some Hiroshima Survivors at Thyroid Cancer Risk 2Health News:Some Hiroshima Survivors at Thyroid Cancer Risk 3Health News:Deer Farm Industry in Michigan Issues Statement on the Recent Chronic Wasting Disease Case Identified on a Kent County Deer Farm 2Health News:Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market 2Health News:Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market 3Health News:Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market 4
...the Journal of the American Medical Association's ...erly women who have not received// up to the mark ...in delayed diagnoses, as compared to the younger l...te Medical Center of Orange County, Calif., and co...
...ssage and if sound bytes from the Food and Drink F...pular brands// have been doing their bit to reduce...e FDF books speak about a whopping ?1.5 billion wo... the fat portion cut-off for the good health of po...
...h causes most genital warts, is also held responsi...istics claim that over 2,800 women are diagnosed w...to it each year in the UK. A vaccine named Gardsil...ved effective in protecting humans from the most d...
...vidence to show that a couple of weeks of regular ...the risk of onset of pneumonia// and other lung di... in cardiac patients. The study conducted at Univ...erlands was done on 279 heart patients requiring ...
Other Medicine News:
(Date:8/26/2008)...- Cambridge Research &,Instrumentatio...(TM) EX In,Vivo Imaging System. The new system inc...nd becomes the entry-level instrument of choice fo...www.newscom.com/cgi-bin/prnh/20080826/NETU054 ), ...ent of CRi,s unique,solid-state tunable optics tha...
(Date:8/25/2008)...tion and Treatment Strategies--, PHILADELPHIA, Au...iscovered gene mutations that are the main cause o...uroblastoma. In addition, the researchers found,th...igh-risk forms of,non-inherited neuroblastoma, the...y enables us to offer the first genetic tests to f...
(Date:8/22/2008)...Trial Sponsored by Medical Research Council, LEXI...devus,Pharmaceuticals, Inc. (Nasdaq: IDEV ) annou...l MDP 301, a Phase III clinical trial of PRO 2000,...he prevention of HIV and other,sexually transmitte...,Kingdom,s Medical Research Council (MRC) and cond...
(Date:8/21/2008)... /PRNewswire-USNewswire/ -- Dangerous disease,ofte...he lab. To remedy,that, researchers at Kansas Stat...ime from days down to hours., Sanjeev Narayanan, ...icrobiologist, both in the department of diagnosti... DNA spotted microarray to seek out the,specific g...
Breaking Medicine Technology:CRi Announces New Maestro(TM) EX In Vivo Imaging System with Improved Performance and an Affordable Price 2Gene That Causes Childhood Cancer Neuroblastoma Is Found 2Gene That Causes Childhood Cancer Neuroblastoma Is Found 3Gene That Causes Childhood Cancer Neuroblastoma Is Found 4Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000 2Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000 3Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000 4Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000 5Rapid Test for Pathogens Developed By K-State Researchers Could Be Used to Detect Diseases Used By Bioterrorists 2Cellular decision on the computer 23898 1Cellular decision on the computer 23898 2Huntingtons disease 3A catching it early 4006 1New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 1New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 2New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 3New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 4New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 5New studies predict record land grab as demand soars for new sources of food energy and wood fiber 4003 6Aspire IRB Announces the Launch of an Automated Web Portal System 23895 1Aspire IRB Announces the Launch of an Automated Web Portal System 23895 2
...GUARDIA (COMO), Italy--(BUSINESS WIRE)--Apr 23, 20... today reported that,its lead product, Defibrotide...the World Congress of Nephrology 2007 being held i...On Monday, April 23, 2007, Cinara Echart, Ph.D., M...m, will present a poster,entitled "Defibrotide Mod...
...S, Texas and NUTLEY, N.J., April 23, 2007 /PRNewsw...ed that if a renal anemia,treatment administered o...stration of epoetin alfa, hemodialysis centers may... $44,000 per year per 100,patients. These data, fr...anagement in hemodialysis patients, were presented...
Other Medicine Technology:Gentium's Defibrotide Highlighted in Poster Presentation at World,Congress of Nephrology 2Gentium's Defibrotide Highlighted in Poster Presentation at World,Congress of Nephrology 3Prospective Model Outlined Potential Time and Cost Savings of,Once-Monthly Anemia Treatment 2Prospective Model Outlined Potential Time and Cost Savings of,Once-Monthly Anemia Treatment 3
...ce the finest surgical-quality loupes available a...for innovative optical design, combining superior ...g optimum performance with maximum comfort, SheerV...essionals worldwide. All SheerVision loupes come c...
...ce the finest surgical-quality loupes available a...for innovative optical design, combining superior ... optimum performance with maximum comfort, SheerVi...ssionals worldwide. Make both a professional and a...
...ce the finest surgical-quality loupes available a...for innovative optical design, combining superior ... optimum performance with maximum comfort, SheerVi...ssionals worldwide. All SheerVision loupes come co...
...ion manufactures its signature line of award-winni...ightweight, yet durable titanium frame. These next...on razor-sharp clarity, an ultra-lightweight desi...-fog, and scratch resistance. With SheerVision fl...
Medicine Products: