Navigation Links
Amicus Therapeutics Presents Positive Results From Phase 2 Extension Study of Amigal(TM) for Fabry Disease at ACMG 2009 Annual Meeting
Date:3/28/2009

Data provide support for expected Phase 3 program

CRANBURY, N.J., March 28 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) announced today positive results from its ongoing Phase 2 extension study of its investigational drug, Amigal(TM) (migalastat HCL) for Fabry disease. The results will be presented at the American College of Medical Genetics (ACMG) 2009 Annual Meeting in Tampa, FL.

Phase 2 Extension Study Overview:

Twenty-six subjects completed either 12 or 24 weeks of treatment during Phase 2 studies. Twenty-three of the 26 subjects continue to receive treatment in an ongoing extension study designed to evaluate the long term safety and efficacy of Amigal. Ten of the 23 subjects have been on treatment for at least 2 years and 4 subjects have been on treatment for more than 3 years.

Preliminary Results:

Treatment with Amigal was generally well-tolerated, with no drug-related serious adverse events. The most common adverse events were headache, arthralgia and diarrhea.

Subjects identified as responders to Amigal at the completion of the Phase 2 studies continued to maintain elevated levels of the target enzyme (a-Gal A), as measured in white blood cells, and reduced levels of the target substrate (kidney GL-3), as measured in urine.

A reduction of GL-3 levels was also observed in interstitial capillary cells from kidney biopsies. Previously reported Phase 2 results indicated that little to no GL-3 was detected in these cells in most subjects prior to treatment with Amigal. The new data were obtained from the retesting of biopsies using an improved methodology.

Preliminary results from the evaluation of modified doses and a new dosing regimen were also presented.

Derralynn
'/>"/>

SOURCE Amicus Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Amicus Therapeutics to Present at the Cowen and Company 29th Annual Healthcare Conference on March 17, 2009
2. Amicus Therapeutics Announces Change to Board of Directors
3. Amicus Therapeutics Announces Fourth Quarter and Full Year 2008 Financial Results
4. Amicus Therapeutics Announces Fourth Quarter and Year End 2008 Financial Results Release Date
5. Amicus Therapeutics Adds Sol J. Barer, Ph.D. to Board of Directors
6. Amicus Therapeutics to Present at Lazard Capital Markets Healthcare Conference
7. Amicus Therapeutics Announces Third Quarter 2008 Financial Results
8. Amicus Therapeutics Announces Third Quarter 2008 Results Release Date
9. Amicus Therapeutics to Present at the 2008 UBS Global Life Sciences Conference
10. Amicus Therapeutics Opens Research Facility in San Diego
11. Amicus Therapeutics to Present at the 2008 BioCentury NewsMakers in the Biotech Industry Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... LAS VEGAS , July 31, 2015 /PRNewswire/ ... pharmacists seek resources that help them drive positive ... as a vital source of patient care in ... Pharmacy,s annual tradeshow and conference, AmerisourceBergen announced ... strengthen its Pharmacy Services Administration Organization and help ...
(Date:7/30/2015)... ATLANTA , July 30, 2015 ... leaders to the 2015 AACC Annual Meeting & ... from July 26–30. The meeting showcased revolutionary ... improves the ability of healthcare providers to diagnose ... get effective medical treatment. As ...
(Date:7/30/2015)... , CA (PRWEB) , ... July 30, 2015 ... ... the successful completion of a field clinical study of its canine osteoarthritis stem ... together with Aratana Therapeutics (Kansas City, KS) and will be marketed in the ...
(Date:7/30/2015)... HIGHLIGHTS:Q2 2015 Results (all changes are against the ... $697 million compared to $701 million in the second ... changes in foreign currency exchange rates decreased sales by ... By business unit, organic sales growth was 6% in ... , Reported diluted EPS was $0.98 compared to ...
Breaking Biology Technology:AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 3Innovative Research on Cancer, Heart Disease, and Infectious Diseases Draws More than 17,500 Attendees to 2015 AACC Annual Meeting 2Innovative Research on Cancer, Heart Disease, and Infectious Diseases Draws More than 17,500 Attendees to 2015 AACC Annual Meeting 3Innovative Research on Cancer, Heart Disease, and Infectious Diseases Draws More than 17,500 Attendees to 2015 AACC Annual Meeting 4VetStem Biopharma Successfully Completes Large Milestone Efficacy Study for its Flagship Canine Osteoarthritis Stem Cell Product 2VetStem Biopharma Successfully Completes Large Milestone Efficacy Study for its Flagship Canine Osteoarthritis Stem Cell Product 3Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 2Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 3Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 4Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 5Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 6Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 7Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 8Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 9Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 10Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 11Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 12Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 13Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 14Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 15Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 16Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 17Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 18Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 19Sigma-Aldrich (NASDAQ - SIAL) Reports Q2 2015 Sales Of $697 Million And Adjusted Diluted EPS Of $1.01 20
... FRAZER, Pa. and PHILADELPHIA, Oct. 21 ,Cephalon, Inc. ... EURX ) today announced,receipt of a Paragraph ... an Abbreviated New Drug Application (ANDA) submitted to ... Pharmaceuticals, Inc.,requesting approval to market and sell a ...
... ARBOR, Mich., Oct. 21 Terumo Heart, Inc. ... Left Ventricular,Assist System (LVAS), marking an important early ... by Dr. Francis Pagani performed the five implants,at ... Arbor with three,of the surgeries performed off-pump., ...
... the Trial,s First Stage ... Objective Tumor Responses- -Patient ... Oct. 21 Peregrine,Pharmaceuticals, Inc. (Nasdaq: PPHM ), a clinical ... announced that updated preliminary data from the first,stage of its Phase ...
Cached Biology Technology:Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules 2Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules 3Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules 4Fifth DuraHeart(TM) U.S. Implant Marks Important Milestone in U.S. Pivotal Trial 2Peregrine Pharmaceuticals Reports Progress in Its Phase II Trial of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer 2Peregrine Pharmaceuticals Reports Progress in Its Phase II Trial of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer 3Peregrine Pharmaceuticals Reports Progress in Its Phase II Trial of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer 4
(Date:7/9/2015)... 2015 Research and ... the "Biometrics for Banking; Market & Technology ... to their offering. The adoption for ... growth and the forecast is that by 2020 ... companies involved in delivering biometric systems to the ...
(Date:7/8/2015)... Summary Pancreatic cancer is the 12th ... with a mortality rate of 10.9 deaths per 100,000 ... patients has highlighted a significant need for new and ... by the current market. A highly active pancreatic ... molecule types and mechanisms of action, which provides a ...
(Date:7/8/2015)... 8, 2015 The consumer products industry ... must have products such as wearables, smart wallets & other ... biometrics based devices continues to rapidly grow.  Biometrics & Wearable ... NXTD ), Google Inc. (NASDAQ: GOOG ), Apple Inc. ... GoPro, Inc. (NASDAQ: GPRO ) and Baidu Inc. (NASDAQ: ...
Breaking Biology News(10 mins):Global Banking Biometrics Market 2015-2020 - Market & Technology Analysis, Adoption Strategies and Forecasts 2Global Banking Biometrics Market 2015-2020 - Market & Technology Analysis, Adoption Strategies and Forecasts 3Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation 2Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation 3Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 2Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 3Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 4Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 5Consumers Flock to This Summer's Must Have Tech Gadgets as Latest Digital Wallets, Smart Technology & Wearable Products Continue to Grow in Popularity & Functionality 6
... in the United Kingdom and the Netherlands are ... progressively more resistant to antibiotics over the last ... more stringent rules on use of antibiotics in ... that broadly improves water quality in surrounding environments. ...
... 3, 2010) A scientific "Renaissance man" whose ... and polymer physics, Erez Lieberman-Aiden, graduate student at ... has been named the winner of the prestigious ... 2010 $30,000 Lemelson-MIT Collegiate Student Prize winners announced ...
... Blacksburg, Va. Poor air quality apparently affects the ... by Virginia Tech civil and environmental engineer Linsey Marr. ... race results, weather data, and air pollutant concentrations in seven ... top three male and female finishing times were compared with ...
Cached Biology News:MIT student inventor honored for transformative work in genomics and linguistics 2MIT student inventor honored for transformative work in genomics and linguistics 3Women more affected than men by air pollution when running marathons 2
... Now, for the first time, you ... faster and more efficiently without interferences. The ... to remove unwanted, multiple high-abundant proteins from ... with just one device. With this ...
... Chemicon Select Tissue Arrays are intended ... individual tissues were fixed in neutral buffered ... identification and diagnosis was performed by certified ... their paraffin blocks and relocated into a ...
... The Agilent Two-Color RNA Spike-In Kit contains ... anneal only to complementary control probes on ... The spike-ins serve as a positive microarray ... NOTE: This kit is a required ...
... the industry standard microarray image analysis software ... and analysis tools, visualizations, automation capabilities, performance ... included with every GenePix scanner, and it ... and all types of arrays. A wide ...
Biology Products: