Navigation Links
Edison Pharmaceuticals to Provide Expanded Access to EPI-743 for Mitochondrial Disease
Date:6/8/2011

MOUNTAIN VIEW, Calif., June 8, 2011 /PRNewswire/ -- Edison Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has allowed an Expanded Access program to provide EPI-743 to seriously ill patients diagnosed with inherited respiratory chain diseases of the mitochondria. Patients with genetically confirmed disease and patients who meet specific clinical criteria, absent genetic confirmation are both eligible.

As of June 1, 2011, 40 seriously ill subjects diagnosed with genetically confirmed inherited mitochondrial disease have been treated with EPI-743 worldwide for a cumulative exposure of over 7,436 days. No significant drug-related adverse events have been observed. Initial clinical, biomarker, and brain-imaging data are encouraging. The company cautions that the data obtained in these initial studies is preliminary and needs verification in controlled prospective trials. Edison and its clinical investigator team are working closely with FDA and the European Medicines Agency to expedite prospective phase 2B/3 clinical trials. EPI-743 has received orphan designation from FDA.

Clinical Trial Sites

United States

Clinical trial enrollment sites have been established in North America at Lucile Packard Children's Hospital– Stanford University Medical Center; Akron Children's Hospital; Columbia University; Seattle Children's Hospital; Medical University of South Carolina; Children's Hospital of Philadelphia; and University of California, Los Angeles.

Additional trial sites are being established in Europe, Japan, and in North America.

Treatment Information

Edison Pharmaceuticals

— EdisonPharma.com

United Mitochondrial Disease Foundation

— UMDF.org

Friedreich's Ataxia Research Alliance

— CureFA.org

MitoAction

— MitoAction.org

United States Food and Drug A
'/>"/>

SOURCE Edison Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Edison Pharmaceuticals Announces FDA Grants EPI-743 Orphan Drug Designation
2. Samsung Medison Pledges to Become a World-Class Medical Device Company
3. NOMAD by Aribex Receives Edison Best New Product Award
4. Quest Diagnostics Honored for Diagnostic Innovation at 2011 Edison Awards
5. Osteotechs Plexur M® Technology Wins Thomas Alva Edison Patent Award from the New Jersey Research and Development Council
6. Zargis Medical Strikes Gold at 2010 Edison Awards
7. Orthocare Innovations Compas and Smart Pyramid Recognized at Edison Best New Product Awards
8. Zargis Cardioscan Jointly Named as Finalist in 2010 Edison Best New Product Awards
9. Edison Pharma Hits Milestone as A0001 Enters Phase 1 Clinical Development
10. Topaz Pharmaceuticals Announces New Drug Application for the Treatment of Head Lice Accepted by FDA
11. Aeolus Pharmaceuticals, Inc. Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... , Jan. 14, 2014 HeartWare International, Inc ... of less invasive, miniaturized circulatory support technologies that are ... that it expects revenues for the fourth quarter of ... 2013 revenues to approximately $208 million. "Our ...
(Date:1/14/2014)... Jan. 14, 2014 The Brandeis Medical Center, led by Dr. ... a premier and affordable laser tattoo removal experience with the advanced ... is in providing high quality cosmetic services with cutting edge medical ... " Southern California has seen a dramatic increase ...
(Date:1/14/2014)... Va. , Jan. 14, 2014 Animal Emergency Critical Care, ... Leesburg, Virginia is the first in ... oxygen chamber. Dr. Susan M. Barnes , ... Dr. Barnes and husband, Dr. Cole Taylor , are avid ...
Breaking Medicine Technology:HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2
... ... ... ... ...
... ... ... ... ...
Cached Medicine Technology:ATS Medical Announces Fourth Quarter and Full Year 2009 Results 2ATS Medical Announces Fourth Quarter and Full Year 2009 Results 3ATS Medical Announces Fourth Quarter and Full Year 2009 Results 4ATS Medical Announces Fourth Quarter and Full Year 2009 Results 5ATS Medical Announces Fourth Quarter and Full Year 2009 Results 6ATS Medical Announces Fourth Quarter and Full Year 2009 Results 7ATS Medical Announces Fourth Quarter and Full Year 2009 Results 8ATS Medical Announces Fourth Quarter and Full Year 2009 Results 9ATS Medical Announces Fourth Quarter and Full Year 2009 Results 10ATS Medical Announces Fourth Quarter and Full Year 2009 Results 11ATS Medical Announces Fourth Quarter and Full Year 2009 Results 12ATS Medical Announces Fourth Quarter and Full Year 2009 Results 13ATS Medical Announces Fourth Quarter and Full Year 2009 Results 14ATS Medical Announces Fourth Quarter and Full Year 2009 Results 15ATS Medical Announces Fourth Quarter and Full Year 2009 Results 16ATS Medical Announces Fourth Quarter and Full Year 2009 Results 17ATS Medical Announces Fourth Quarter and Full Year 2009 Results 18ATS Medical Announces Fourth Quarter and Full Year 2009 Results 19ATS Medical Announces Fourth Quarter and Full Year 2009 Results 20ATS Medical Announces Fourth Quarter and Full Year 2009 Results 21WorldHeart Reports 2009 Financial Results 2WorldHeart Reports 2009 Financial Results 3WorldHeart Reports 2009 Financial Results 4WorldHeart Reports 2009 Financial Results 5WorldHeart Reports 2009 Financial Results 6WorldHeart Reports 2009 Financial Results 7WorldHeart Reports 2009 Financial Results 8
(Date:4/17/2014)... today in PLOS Pathogens , children who live ... can mount an immune response to infection with malaria ... of high fever and illness and partially control the ... may help researchers develop future interventions that prevent or ... Each year, approximately 200 million cases of malaria occur ...
(Date:4/17/2014)... the University of California, San Diego School of Medicine ... have suffered a recent major loss are more likely ... , The study is published in this month,s issue ... , Because compassionate behaviors are associated with better health ... insights into ways to improve the outcomes of individuals ...
(Date:4/17/2014)... In a review published in the April issue ... of The Feinstein Institute for Medical Research, says it,s ... community,s approach to treating sepsis, which kills ... , Sepsis occurs when molecules released into the bloodstream ... the body. Inflammation is necessary for maintaining good health ...
(Date:4/17/2014)... Northwestern University synthetic biology team has created a ... programmable therapeutics that could travel the body and ... , Engineering cell-based, biological devices that monitor and ... clinical synthetic biology. However, no existing technology enabled ... patient,s physiological state and respond in a customized ...
(Date:4/17/2014)... Doctors who treat patients with a severe ... face an agonizing treatment decision. , The drug ... help relieve shortness of breath. But some patients ... cause potentially fatal complications following transplantation. , "It,s ... medical director of Loyola University Medical Center,s LAM ...
Breaking Medicine News(10 mins):Health News:Study sheds light on how the immune system protects children from malaria 2Health News:The ilk of human kindness 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Building 'smart' cell-based therapies 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3
... also at all-time low, government report shows, , WEDNESDAY, Dec. ... States has reached almost 78 years, a record high, federal ... can expect to live to 80.4 years on average and ... U.S. Centers for Disease Control and Prevention. , But ...
... ORLEANS, Dec. 16 A new software program developed by ... facilities to calculate their staffing needs as it relates to ... healthcare facilities to calculate their mandatory nurse-to-patient staffing needs, comply ... report as to how it affects their bottom line. ...
... , SAN FRANCISCO, Dec. 16 Quantros, ... and professional services solutions for the healthcare industry, announces ... Quantros has named software industry veteran Michael Tulloch, MBA, ... from the company,s new Marlborough, MA office. , "The ...
... an amino acid typically found in red meats, fish, ... possibly increase the risk of developing Alzheimer,s disease, according ... published their findings, titled "Diet-induced hyperhomocysteinemia increases Amyloid-β formation ... in the journal Current Alzheimer Research . ...
... ... and Jackie Kirby have been chosen as the company’s Recruiters of the Year in ... year that Chris has received such honors and the first for Jackie. , ... (PRWEB) December 16, 2009 ...
... , CAMBRIDGE, Mass., Dec. 16 Sermo ( ... announced the results of a new Sermo Vitals Report titled ... examines physician dialog about diabetes over a one-year period and ... the therapies physicians discuss most frequently, the brands they prefer, ...
Cached Medicine News:Health News: Life Expectancy in U.S. Hits New High 2Health News: Life Expectancy in U.S. Hits New High 3Health News:United States Patent Office Allows CareRise Patent on 24/7 Staff-Census Software 2Health News:Safety and Quality Software Developer Quantros, Inc. Launches Healthcare IT Consulting Division 2Health News:Diet high in methionine could increase risk of Alzheimer's 2Health News:Medical Solutions is Proud to Announce Chris Wepfer and Jackie Kirby as the Company's Recruiter of the Year Recipients 2Health News:Medical Solutions is Proud to Announce Chris Wepfer and Jackie Kirby as the Company's Recruiter of the Year Recipients 3Health News:Sermo Vitals Report(TM) Quantifies One Year of Physician Conversation About Diabetes 2Health News:Sermo Vitals Report(TM) Quantifies One Year of Physician Conversation About Diabetes 3
The Sabre 2400 provides high power performance and key user features to meet today's demanding electrosurgical needs. It is an ideal general-purpose electrosurgical generator....
The ExcaliburPlus PC is the most powerful isolated ESU with 10,000 V PTP in spray coag....
Finesse II electrosurgical generator (100-120 VAC) utilizes a patented design that integrates the electrosurgical generator and smoke evacuation system into a single compact unit....
... 950, the first High Frequency Desiccator with Cut. ... half of the unit is a high frequency ... popular Aaron 900. The other half is a ... power and coag capabilities plenty of power ...
Medicine Products: