Navigation Links
Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
Date:6/22/2009

arting and look forward to continued involvement with this novel approach for the treatment of Fabry disease."

Amigal U.S. Registration Phase 3 Trial Design

The Phase 3 trial will evaluate the efficacy, safety and pharmacodynamics of Amigal in males and females with Fabry disease. This trial will consist of a six-month double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60 subjects who are naive to enzyme replacement therapy (ERT) or who have not received ERT for at least six months prior to the start of treatment with Amigal. The Amigal treatment arm dose and regimen will be 150 mg every other day.

The primary endpoint will be the change in the amount of kidney interstitial capillary GL-3 as measured in kidney biopsies using histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including glomerular filtration rate (GFR) and 24-hour urine protein).

Additionally, the FDA and Amicus reached agreement on an improved methodology for the histological evaluation of GL-3 in the kidney biopsies. An analysis of the Phase 2 and Phase 2 extension study biopsies using the improved methodology demonstrated that all of the evaluable baseline samples had detectable interstitial capillary GL-3 and that reductions were observed in 8 of the 9 responders.

According to Laura Barisoni, MD, Assistant Professor in Pathology and Medicine, Director, Nephropathology Service, Department of Pathology, New York University School of Medicine, "The Phase 2 data using the improved methodology for histological evaluation of GL-3 in kidney biopsies were very encouraging and provide added confidence in the planned Phase 3 study."

It is expected that approximately 30 clinical sites worldwide will participate in this tria
'/>"/>

SOURCE Amicus Therapeutics
Copyright©2009 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:3/27/2015)... 27, 2015  The quality function within the medical ... meet quality standards at every stage of the product ... leaders also have the challenge of balancing quality and ... who don,t effectively balance these priorities risk funding and ... failure and regulatory scrutiny. For the third ...
(Date:3/27/2015)... March 27, 2015 Levi & Korsinsky announces ... (NASDAQ: OHRP ) concerning possible violations of federal ... the Company in connection with its study of the ... http://zlk.9nl.com/ohr-pharmaceutical-ohrp or contact Joseph E. Levi, Esq. ... by telephone at (212) 363-7500, toll-free: (877) 363-5972. ...
(Date:3/27/2015)... WINNIPEG , March 27, 2015 /PRNewswire/ - Medicure ... Board of Directors has approved the grant of an ... management company employees and consultants of the Company pursuant ... 181,070 are set to expire on the tenth anniversary ... expire on the third anniversary of the date of ...
Breaking Medicine Technology:New Medical Device Quality Study Finds Regulatory Environment is Boosting Quality Spending, Especially for Large Companies 2
... Terumo Heart Inc., a wholly owned subsidiary of ... the worldwide expansion of its DuraHeart(TM) Left-Ventricular Assist System ... Arusoglu, MD and Michiel Morshuis, MD, cardiothoracic surgeons at ... Diabetes Center NRW, University Hospital of the Ruhr-University of ...
... select markets worldwideNATICK, Mass., May 19 Boston ... announced the launch of the platinum chromium TAXUS(R) ... worldwide. The TAXUS Element Stent features a ... stent applications and represents the Company,s third-generation drug-eluting ...
Cached Medicine Technology:Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 2Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 3Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System 4Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 2Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 3Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 4Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent 5
(Date:3/28/2015)... Servpro of Paso Robles , ... report about the link between mold and asthma. Mold ... to recent medical research, may even cause asthma in ... Protection Agency, people with sensitivity to mold or mold ... trigger asthma attacks for asthma sufferers. The EPA recommends ...
(Date:3/27/2015)... March 27, 2015 In her mid-forties and ... her from working, Monica K. arrived at JET Uniform ... department quiet, defensive and scared. The owners and staff at ... Services (EPSS) to offer jobs to challenged residents like ... and a willingness to begin with the end in mind,” ...
(Date:3/27/2015)... 27, 2015 Bleeding is one ... percutaneous coronary intervention (PCI), resulting in increased mortality, ... “risk-treatment paradox,” in which the highest-risk PCI patients ... treated less often with bleeding avoidance strategies than ... Mid America Heart Institute asked the question whether ...
(Date:3/27/2015)... NY (PRWEB) March 27, 2015 Ticket Down is ... Concert in 2015. After a phenomenal and highly successful ... "Nashville" will be going out on tour again in 2015 and ... tour gets underway on April 29th in New York City at ... at the Comerica Theatre on May 10th. , Fans of the ...
(Date:3/27/2015)... According to a recently published report series ... screw market in Europe is in decline due to ... segment. Price decreases are being seen across the entire ... the total European trauma device market, continued pricing pressure ... year after year. , “Such price drops are ...
Breaking Medicine News(10 mins):Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 2Health News:Water Damage Restoration Specialists Servpro of Paso Robles Release Report on Mold and Asthma 3Health News:Red Deer Uniforms Shop Celebrates 3rd Year Sewing Hope for the Challenged 2Health News:Red Deer Uniforms Shop Celebrates 3rd Year Sewing Hope for the Challenged 3Health News:Precision Medicine Improves Use of Bleeding Avoidance Strategies and Reduces Bleeding in Patients Undergoing Percutaneous Coronary Intervention 2Health News:Precision Medicine Improves Use of Bleeding Avoidance Strategies and Reduces Bleeding in Patients Undergoing Percutaneous Coronary Intervention 3Health News:Nashville Live in Concert Tickets in New York, Boston, Washington, DC, Chicago, Minneapolis, San Francisco, Los Angeles and Phoenix Now On Sale at TicketDown.com 2Health News:Titanium Trauma Treatment Devices in Europe Becoming More Affordable, Decreasing Market Value: Group Purchasing Further Eroding Selling Prices 2Health News:Titanium Trauma Treatment Devices in Europe Becoming More Affordable, Decreasing Market Value: Group Purchasing Further Eroding Selling Prices 3
... ... youth-enhancing procedures, dermatologists question the impact the silver screen’s ageless face has on mainstream ... Anaheim, ... especially for female actresses. Carla Gugino, an actress of Night at the Museum, ...
... ... Free App for House Health Care Act , ... Comprehending the over 2000 pages contained within HR 3200, the House Bill ... become almost 40% easier for Americans thanks to a cooperative effort between Hearthebill.org and ...
... NEWPORT BEACH, Calif., Dec. 28 With the New Year just ... resolutions. , , Lose weight., ... underlying theme of most New Year,s resolutions is health-related, many tend ... visits to the doctor. Even more so, we forgo the regular ...
... Scientists have created what appears to be a schizophrenic ... in complex reasoning and decisions about appropriate social behavior. ... Dec. 28 in PNAS, elucidate the critical balance between ... go awry in schizophrenia. They also provide the first ...
... show up, but they,re there, study finds , MONDAY, Dec. 28 ... over the long term, a new study finds. , "There appears ... statement by Dr. Johan Arnlov, an associate professor of cardiovascular epidemiology ... Dec. 28 in the journal Circulation . , That assessment ...
... , , , , , ... obese nation. It,s no surprise then, battling the bulge becomes a ... to about.com). Experts preach to win the weight war; individuals must ... foods they eat. This year, Matterhorn and Crystal Light offer two ...
Cached Medicine News:Health News:Dermatologists Dissect Hollywood's Ageless Face Obsession 2Health News:House Health Care Bill Becomes Up To 38% More Understandable 2Health News:Celebrate the New Year With a New You 2Health News:Schizophrenia mouse model should improve understanding and treatment of the disorder 2Health News:Study Debunks Notion of 'Healthy Obese' Man 2Health News:Study Debunks Notion of 'Healthy Obese' Man 3Health News:Make Your 2010 Resolution and Chill Out with Crystal Light Frozen Treats 2
All Day Comfort for the Lower Body...
All Purpose, General Procedure Apron...
The Buckle Apron has a 2" wide belt with a rugged side-release buck. The belt and buckle are adjustable to provide a snug and comfortable fit while still offering .50mm Pb protection....
Features four-way apron closure for super adjustability to fit staff of all shapes and sizes. Top left and right shoulder closures allow adjustment of armhole size and chest area of apron for close a...
Medicine Products: