Navigation Links
Amicus Therapeutics Announces Second Quarter 2009 Financial Results
Date:8/5/2009

is year.

As previously announced, the Phase 3 trial will evaluate the efficacy, safety, and pharmacodynamics of Amigal in males and females with Fabry disease. The 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 eight of the nine responders.

It is expected that approximately 30 clinical sites worldwide will participate in this trial.

Plicera(TM) (afegostat tartrate) for the treatment of Gaucher Disease

A Phase 2 clinical trial of the Company's investigational drug Plicera is ongoing. This 6-month study is designed to evaluate safety, dosing, and preliminary efficacy, as measured by the standard endpoints in Gaucher disease. The Company expects to report the results early in the fourth quarter of 2009.

Amicus continues to work closely with its partner, Shire HGT, to prepare for Phase 3 development
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10 11 12

Related biology technology :

1. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotech & Medtech 2007 Conference
2. Amicus Therapeutics Announces Third Quarter 2007 Financial Results
3. Meredith Martin Addy Named Chair of AIPLAs Amicus Committee
4. Amicus Therapeutics to Present at the Lazard Capital Markets Fourth Annual Healthcare Conference
5. Amicus Therapeutics to Host R&D Day
6. Amicus Therapeutics Announces Positive Results From Phase 2 Clinical Trials of Amigal(TM) for Fabry Disease
7. Amicus Therapeutics Announces Fourth Quarter and Full Year 2007 Financial Results & Program Advancements
8. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
9. Amicus Therapeutics to Present at the BIO CEO & Investor Conference 2008
10. Amicus Therapeutics Presents Positive Data from Phase 2 Clinical Trial of Plicera(TM) for Gaucher Disease
11. Amicus Therapeutics to Present at the Morgan Stanley Global Healthcare Unplugged Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... , Dec. 18, 2014 Egenix, Inc. is pleased ... elected Chairman of the Board, to succeed Donald Fresne ... but will continue as a member of the Board.  In ... added to the company over almost twenty years, the Board ... Board of Directors has established a Search Committee to find ...
(Date:12/17/2014)... The Activated Carbon Manufacturing ... why IBISWorld updated its original industry research report. ... an intensified focus on environmental policy. Over the five ... for power plants and a range of other industrial ... Analyst Sarah Kahn, “a range of downstream industrial sectors ...
(Date:12/17/2014)... Houston, TX (PRWEB) December 17, 2014 ... marketing and administration for Stoller Group. In this position, ... Stoller Group, on administrative matters, develop marketing strategy and ... and services. , “Achim has tremendous knowledge and ... president of Stoller Group. “His experience and innovative thinking ...
(Date:12/17/2014)... This report is a professional and ... an overview analysis, the report introduces quartz tubing ... industry overview, policy analysis, and news analysis, etc. ... witnessed rapid development with key manufacturers increasing their ... mentions quartz tubing upstream raw materials and equipment, ...
Breaking Biology Technology:Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 2Activated Carbon Manufacturing in the US Industry Market Research Report Has Been Updated from IBISWorld 3Achim Noack Joins Stoller Group as Global Vice President of Marketing and Administration 22020 Quartz Tubing Market: Global Development & Forecasts Analysis Now at DeepResearchReports.com 2
... Dec. 3 Today, the International Society,for Stem Cell ... researchers, released new guidelines for the responsible,development of safe ... article that summarizes the Guidelines for the Clinical Translation,of ... the December issue of Cell,Stem Cell, the official affiliated ...
... Alternext US: NBS), which is pioneering the pre-disease collection,processing and ... announced that it has completed an above market financing for ... unit with each unit,consisting of one share of common stock ... $1.75 per share. , ...
... The William Lehman Injury Research,Center (WLIRC), ... the, University of Miami /Jackson Medical Center,s ... Advanced Technology Research Center (TATRC); the Army,Trauma ... (ATA) and,Qualcomm, through its Wireless Reach(TM) initiative, ...
Cached Biology Technology:The International Society for Stem Cell Research Releases New Guidelines to Shape Future of Stem Cell Therapy 2The International Society for Stem Cell Research Releases New Guidelines to Shape Future of Stem Cell Therapy 3The International Society for Stem Cell Research Releases New Guidelines to Shape Future of Stem Cell Therapy 4NeoStem Completes $500,000 Private Placement With Strategic Investor 2NeoStem Completes $500,000 Private Placement With Strategic Investor 3Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami 2Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami 3Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami 4Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami 5Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami 6
(Date:12/19/2014)... DUBLIN , Dec. 18, 2014 Research and ... addition of the "Micro Market Monitor: North America ... http://photos.prnewswire.com/prnh/20130307/600769 ... grow at a CAGR of 3.6% from 2014 to ... in this market, Canada is ...
(Date:12/17/2014)... YORK , Dec. 15, 2014  HITLAB ... Good Clinical Practices (GCP) audit to confirm its ... (FDA) regulations. This accomplishment enables HITLAB to conduct ... utilizing the highest principles for patient safety and ... improve global healthcare access, quality, and delivery with ...
(Date:12/11/2014)... , Dec. 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/twhjll/biometrics_market ) has announced ... the APAC Region 2015-2019"  report to their offering. ... this market is advances in technology. With continuous ... biometric solutions to the latest standard that meets ...
Breaking Biology News(10 mins):Micro Market Monitor: North America Perimeter Security Systems Market (Intrusion Detection Sensor, Video Surveillance, Communication/Alarm and Notification, Access Control System) 2Micro Market Monitor: North America Perimeter Security Systems Market (Intrusion Detection Sensor, Video Surveillance, Communication/Alarm and Notification, Access Control System) 3HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2
... persist by depositing their genetic information (DNA) in the ... This prevents antiviral drugs from eliminating these viruses. But ... damaging the infected cell in the liver. In the ... the scientists report that now new therapeutic possibilities are ...
... temperature of our planet increases. This is particularly important ... (ectothermic), including insects. Their body temperature is ultimately determined ... to the speed and efficiency of their vital biological ... or frequency of extreme temperature conditions that have the ...
... by a Wits University scientist has overturned a long-standing ... distinct species in the course of evolution), suggesting that ... than was previously thought. Unlike humans and most ... genes in fact some plants, called polyploids, can ...
Cached Biology News:Degradation of viral DNA in the cell nucleus is opening up new treatment 2Extreme weather decides distribution of insects 2Extreme weather decides distribution of insects 3
...
Anti 4-hydroxy-2-hexenal (4-HHE) Monoclonal Antibody (HNEJ-2)...
... immunostaining ,This solution has effect on enhancing ... clearer signal than the one obtained by ... of secondary antibody used and exposure time ... have images with high S/N ratio and ...
Anti-human VEGFR-2/KDR (Protein-A Purified) Polyclonal Antibody...
Biology Products: