Navigation Links
GSK and Amicus Therapeutics Enter Exclusive Worldwide Agreement to Develop and Commercialize Amigal™ for Fabry Disease
Date:10/29/2010

n.  Treatment with migalastat HCl has been generally well-tolerated, with no drug-related serious adverse events. The most common adverse events were headache, arthralgia and diarrhea.

A Phase 3 study (Study 011) commenced in the second quarter of 2009 and treatment of the first patient began in the fourth quarter of 2009.  This ongoing study is a 6-month, randomized, double-blind trial comparing migalastat HCl to placebo in 60 subjects in approximately 40 investigational sites worldwide. The surrogate primary endpoint is the change in the amount of kidney interstitial capillary GL-3. Subjects being enrolled are Fabry patients who have never received enzyme replacement therapy (ERT), or who have not received ERT for at least 6 months, and who have a mutation responsive to migalastat HCl.

GSK and Amicus today provided an update to the enrollment timeline for Study 011.  Enrollment is now expected to be completed in the first quarter of 2011 and preliminary results are expected to be announced in the second half of 2011.

Furthermore, a separate Phase 3 study (Study 012) is expected to commence before year end.  The study will be an 18-month, randomized, open-label study comparing migalastat HCl to ERT in approximately 60 subjects. The primary outcome of efficacy will be renal function as measured by glomerular filtration rate (GFR).

About Fabry DiseaseFabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A).  The role of alpha-Gal A within the body is to break down a complex lipid called globotriaosylceramide (GL-3).  Reduced or absent levels of alpha-Gal A activity leads to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin. This accumulation of GL-3 is believed to cause the various symptoms of Fabry disease, including pain, kidney failure, and increased risk of hear
'/>"/>

SOURCE Amicus Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
2. Amicus Therapeutics Announces Plans to Present Phase 1 Data for AT2220 for Pompe Disease
3. Amicus Therapeutics Announces Positive Results From Two Phase 1 Clinical Studies of AT2220 for Pompe Disease
4. Amicus Therapeutics to Present at the 26th Annual JPMorgan Healthcare Conference
5. Amicus Therapeutics Presents Data from Clinical Ex Vivo Response Study and Phase 1 Studies of AT2220
6. Amicus Therapeutics Begins Phase 2 Clinical Trial of AT2220 in Pompe Disease
7. Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease
8. Amicus Therapeutics Announces Second Quarter 2008 Financial Results
9. Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009
10. Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease
11. Amicus Therapeutics Announces Issuance of New Plicera(TM) Composition of Matter Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2015)... and BOSTON , May 29, 2015 ... development, custom automation, and contract manufacturing, and Vaxxas ... needle-free drug delivery technology, have been named winners of ... Nanopatch Jet Coating Instrument , an advanced technology ... product development.  The award was announced last evening at ...
(Date:5/29/2015)... May 29, 2015 /CNW/ - Covalon Technologies Ltd. (the ... technologies company, is delighted to announce its financial ... 2015, which includes revenue for three months of ... $264,340. Revenue from advanced wound care product sales for ... increased 24% to $1,742,672 compared to $1,400,065 for ...
(Date:5/29/2015)... VANCOUVER, British Columbia and ... DelMar Pharmaceuticals, Inc. (OTCQX: ... focused on developing and commercializing proven cancer therapies ... data at the American Association of Cancer ... on the potential for its lead product ...
Breaking Medicine Technology:Invetech And Vaxxas Named Recipients Of The 2015 Good Design Award For Development Of Nanopatch Jet Coating Instrument For Needle-Free Drug Delivery 2Invetech And Vaxxas Named Recipients Of The 2015 Good Design Award For Development Of Nanopatch Jet Coating Instrument For Needle-Free Drug Delivery 3Covalon Announces Strong Second Quarter Results 2Covalon Announces Strong Second Quarter Results 3DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 2DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 3DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 4DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 5
... U.S. Food and Drug Administration (FDA) has accepted for ... of Keppra XR(TM) (levetiracetam) in the, adjunctive ... ATLANTA, Jan. 16 UCB announced today that ... XR(TM) (levetiracetam) extended-,release tablets in the adjunctive treatment of ...
... rate from,cancer now is lower in older adolescents and ... because of a lack of access to clinical trials,nationally ... by pediatric,oncologists at Children,s Hospital of Pittsburgh of UPMC., ... with cancer have,improved dramatically over the last 30 years, ...
Cached Medicine Technology:Keppra XR(TM) Extended-Release Tablets Filed with the FDA 2Keppra XR(TM) Extended-Release Tablets Filed with the FDA 3Keppra XR(TM) Extended-Release Tablets Filed with the FDA 4Children's Hospital Cancer Study Finds Adolescents and Young Adults Don't Get Same Access to Cutting-Edge Treatment as Younger Patients 2Children's Hospital Cancer Study Finds Adolescents and Young Adults Don't Get Same Access to Cutting-Edge Treatment as Younger Patients 3
(Date:5/30/2015)... 30, 2015 Boston Scientific Corp. ... punitive and compensatory damages to a transvaginal mesh ... complications following implantation of the company’s Pinnacle and ... on May 28th in Delaware Superior Court, the ... after the jury found that the implants were ...
(Date:5/30/2015)... 2015 Nicole Blodgett, Vice President ... Associate (DIA) designation to further her expertise in ... designed for insurance advisors, health care professionals, and ... and expertise associated with the risk and the ... is only the latest accomplishment in Nicole's journey ...
(Date:5/30/2015)... (PRWEB) May 30, 2015 Wixom, Michigan: Proof. Pest ... services, has added a new twist to its robust line ... organic services are used for general pest management. ... Allan Draper, proof.’s Wixom Branch Manager. “The average person cringes ... pride in dealing with problems that most people don’t even ...
(Date:5/30/2015)... This year the National Lung Health Education ... one of the most diverse perspectives with speakers and ... diagnose, treat and manage patients with COPD. , "The ... is Interaction with Multidisciplinary Healthcare Professionals who represent various ... with COPD," said Brian W. Carlin, MD, FCCP, FAARC, ...
(Date:5/30/2015)... 30, 2015 The IRS released an ... announcing that, “criminals used taxpayer-specific data acquired from non-IRS ... 100,000 tax accounts through IRS’ “Get Transcript” application. This ... street address.” , “You don’t even have to ... think it was only a matter of time, especially ...
Breaking Medicine News(10 mins):Health News:Boston Scientific Transvaginal Mesh Lawsuit Trial Ends With $100 Million Verdict 2Health News:Boston Scientific Transvaginal Mesh Lawsuit Trial Ends With $100 Million Verdict 3Health News:Boston Scientific Transvaginal Mesh Lawsuit Trial Ends With $100 Million Verdict 4Health News:Secura Consultants Expands Disability Insurance Expertise 2Health News:Proof. Pest Control-Now Offering 100% Organic Pest Control in Southeast Michigan 2Health News:Pulmonary Horizons 2nd Annual COPD Conference Miami Hilton Downtown, July 17-19, 2015 Patient Centered Cross-Continuum Education to Improve the Care of Patients with COPD 2Health News:Pulmonary Horizons 2nd Annual COPD Conference Miami Hilton Downtown, July 17-19, 2015 Patient Centered Cross-Continuum Education to Improve the Care of Patients with COPD 3Health News:IRS Attack Exemplifies the Compounding Dangers of Stolen Personal Data 2Health News:IRS Attack Exemplifies the Compounding Dangers of Stolen Personal Data 3Health News:IRS Attack Exemplifies the Compounding Dangers of Stolen Personal Data 4Health News:IRS Attack Exemplifies the Compounding Dangers of Stolen Personal Data 5
... /PRNewswire-FirstCall/ - CRH Medical Corporation announced today that through ... has been adopted by more than 90% of the ... 2008. The Company believes this provides clear evidence of ... of the consistency of its training methodology. The sharing ...
... A new survey from global market research firm Synovate shows that less ... six months. Of those, only 10% received it at a pharmacy and ... ... (PRWEB) February 24, 2009 -- According to a new survey by leading ...
... Together Leading Cardiovascular ExpertsLAS VEGAS, Feb. 24 ... award-winning company engaged in pioneering highly advanced ... the Company will be showcasing its compelling ... communications products at CardioCareLive, an online-only conference ...
... health plans to adopt the same payment rules as ... Business Group on Health (MBGH) released the results of ... on their knowledge and intentions to improve the safety ... for "never events" - serious and costly preventable hospital ...
... Pioneer in Bid to Raise $1.5 MillionHOUSTON , Feb. 24 ... reach its goal of raising $1.5 million through the ... Heart Association,s Go Red For Women movement. Heart disease is ... United States, with nearly 2,400 Americans dying of the disease ...
... after,TM sessions , , TUESDAY, Feb. 24 (HealthDay News) ... stress and improve their ability to learn, suggests ... meditation (TM) on stress reactivity and brain functioning. ... Washington, D.C., area, underwent physiological and psychological tests ...
Cached Medicine News:Health News:CRH provides Partnership Program update 2Health News:New survey: Flu Shot Still not Catching on, Especially at Retail Clinics 2Health News:Noninvasive Medical Technologies to Exhibit at CardioCareLive - A Premier Cardiometabolic Conference 2Health News:Noninvasive Medical Technologies to Exhibit at CardioCareLive - A Premier Cardiometabolic Conference 3Health News:Employers Support Non-Payment for Hospital-Acquired Infections 2Health News:Employers Support Non-Payment for Hospital-Acquired Infections 3Health News:Photos: Jiffy Lube(R) Halfway Home in Drive to Fight Heart Disease with Maintenance Partners for Life Campaign 2Health News:Photos: Jiffy Lube(R) Halfway Home in Drive to Fight Heart Disease with Maintenance Partners for Life Campaign 3Health News:Photos: Jiffy Lube(R) Halfway Home in Drive to Fight Heart Disease with Maintenance Partners for Life Campaign 4Health News:Photos: Jiffy Lube(R) Halfway Home in Drive to Fight Heart Disease with Maintenance Partners for Life Campaign 5Health News:Meditation May Boost College Students' Learning 2
... Timesh 1.6 Titanium Cranial Fixation Systems ... benefits specifically requested by surgeons and ... cranioplasty implants may be either shaped ... procedure warrants, a pre-measured, cut, bent ...
... LeibingerTitanium Microplus System is a ... skeletal fixation armamentarium. It may ... vault, nasal, zygomatic and orbital ... especially where increased strength over ...
... Sofwire Cable System, designed ... including sublaminar interspinous fixation, ... surgery, sternotomy closure. Consists ... a complete set of ...
Demineralized bone matrix dispensed in a jar. Fibers will be free of foreign matter. Glycerol 70-88% by weight. Calcium content less than 8%....
Medicine Products: