Navigation Links
Amicus Therapeutics Announces Fourth Quarter and Full Year 2008 Financial Results
Date:2/5/2009

ical trial comparing Amigal to placebo based on a surrogate primary endpoint of the change in the amount of kidney GL-3, the substrate that accumulates in the cells of Fabry patients. Amicus is continuing discussions with the FDA through a Special Protocol Assessment (SPA) procedure that it commenced in the fourth quarter of 2008 to finalize how the primary endpoint will be measured. The Company is expecting to finalize the protocol in the second quarter of this year.

Based on discussions with the European Medicines Agency (EMEA) in the fourth quarter of 2008, the Company plans to initiate a separate clinical trial designed to evaluate the safety and efficacy of Amigal versus enzyme replacement therapy (ERT) in Fabry patients. Amicus and its partner Shire Human Genetic Therapies, Inc. (Shire HGT) plan additional discussions with the EMEA to finalize the design of this study.

In parallel with the Phase 3 regulatory discussions, 23 of the original 26 patients from the Phase 2 studies continue to be treated in a voluntary extension study to characterize the long-term safety and efficacy of Amigal and to evaluate additional doses and dose regimens. Amicus expects data from this extension study to be available in the first quarter of 2009.

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

During the fourth quarter, Amicus also focused on executing its ongoing Phase 2 clinical trial of Plicera in Gaucher disease. This 6-month study is designed to evaluate safety and to demonstrate trends of efficacy, as measured by the standard endpoints in Gaucher disease. Amicus previously reported that target enrollment is expected to be surpassed in the study and the Company expects the results to be available in the third quarter of 2009.

Amicus will continue to work closely with its partner, Shire HGT, to prepare for Phase 3 development of Plicera p
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related biology technology :

1. Amicus Therapeutics Announces Fourth Quarter and Year End 2008 Financial Results Release Date
2. Amicus Therapeutics Adds Sol J. Barer, Ph.D. to Board of Directors
3. Amicus Therapeutics to Present at Lazard Capital Markets Healthcare Conference
4. Amicus Therapeutics Announces Third Quarter 2008 Financial Results
5. Amicus Therapeutics Announces Third Quarter 2008 Results Release Date
6. Amicus Therapeutics to Present at the 2008 UBS Global Life Sciences Conference
7. Amicus Therapeutics Opens Research Facility in San Diego
8. Amicus Therapeutics to Present at the 2008 BioCentury NewsMakers in the Biotech Industry Conference
9. Amicus Therapeutics Announces Second Quarter 2008 Results Release Date
10. Amicus Therapeutics Announces First Quarter 2008 Financial Results
11. Amicus Therapeutics to Present at the Morgan Stanley Global Healthcare Unplugged Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Due to a misstatement posted by the ... Cell Technology Center, LLC ( ASCTC ) was reported as ... that might benefit ALS patients. Because of ASCTC's exclusive ... technologies and therapeutic applications, FRC listed ASCTC as one of ... who wish not to support research that requires the death ...
(Date:8/28/2014)... City, Ca. (PRWEB) August 28, 2014 ... E3 rating for an alcohol-based hand sanitizer, asks food ... harvest by comparing the hand sanitizer they’re currently using ... Spray . Hand hygiene is critical to fighting cross-contamination ... environment. Best Sanitizers believes there are key criteria ...
(Date:8/28/2014)... The ability for organizations to attract top ... individuals to perform at the highest of levels, are ... to compete in this post–recession era. The pharmaceutical ... the sector increasingly focuses on the importance of employee-fit ... real results on the organization's development and the innovation ...
(Date:8/28/2014)... new work by a Florida State University research team ... take your temperature, emit white light, and convert photon ... looks like a butterfly. , Biwu Ma, associate professor ... the FAMU-FSU College of Engineering, created the molecule in ... to discover that his creation has many other unique ...
Breaking Biology Technology:The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 2The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 3Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 2Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 3Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 2Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 3Novel 'butterfly' molecule could build new sensors, photoenergy conversion devices 2
... as humans and, just like us, bacteria have their own ... at the Society for General Microbiology,s spring meeting. Uncovering the ... keep industrial microbes at peak performance. Professor van der ... have spent the last three years working out the molecular ...
... conversion of sunlight to electricity could brighten the ... National Laboratory (Berkeley Lab) have found a new ... place in semiconductor thin-films. This new route to ... continues to plague conventional solid-state solar cells. ...
... ... bj-diagnostik, under its brand “DNA-Planet”, introduces a newly structured offer for ... the exact analysis necessary to solve the genetic kinship relation in ... based on the facts of each individual case. In addition, DNA-Planet ...
Cached Biology Technology:New path to solar energy via solid-state photovoltaics 2New path to solar energy via solid-state photovoltaics 3DNA-Planet Launches New Service for Customer-Individual Indirect DNA Paternity Testing and Kinship Analysis 2DNA-Planet Launches New Service for Customer-Individual Indirect DNA Paternity Testing and Kinship Analysis 3DNA-Planet Launches New Service for Customer-Individual Indirect DNA Paternity Testing and Kinship Analysis 4
(Date:8/28/2014)... 25 million kilometres of new roads will be built ... into Earth,s last wildernesses, where they bring an influx ... Now, an ambitious study has created a ,global roadmap, ... to balance the competing demands of development and environmental ... layer that estimates that natural importance of ecosystems and ...
(Date:8/28/2014)... the world to Global Warming, has called for atmospheric ... He says that Carbon Capture, combined with limits on ... global warming getting out of control over the next ... the call during his presentation to the International Carbon ... to discuss Carbon Capture and Storage. , He ...
(Date:8/28/2014)... Biologists at Ludwig-Maximilians-Universitaet (LMU) in Munich have assigned ... genus of predatory arthropods. These animals lived in ... than related forms found in Jurassic strata. ... their shallow marine habitat and were fossilized some ... other denizens of the Silurian seas although ...
Breaking Biology News(10 mins):Study shows where on the planet new roads should and should not go 2Study shows where on the planet new roads should and should not go 3Global warming pioneer calls for CO2 to be taken from atmosphere and stored underground 2Paleontology: Oldest representative of a weird arthropod group 2
... of Biological Sciences (AIBS) and the National Evolutionary ... and workshop for educators at the National Association ... The special symposium, which has become a ... classroom teachers with an opportunity to hear directly ...
... Research and Forestry Applications (CREAF), in the celebration of ... of international experts to discuss the environmental future of ... The work of both days is summarized in the ... Sustainability, which you will find bellow. Targeted to governments ...
... in age-related macular degeneration, the most common cause of ... today in the Lancet , adds to the ... (AMD), which the researchers believe should ultimately lead to ... people aged 80 years or older are affected by ...
Cached Biology News:Illuminating biology: An evolutionary perspective 2Illuminating biology: An evolutionary perspective 3Illuminating biology: An evolutionary perspective 4Barcelona Declaration 2008: Challenges and Pathways to Earth Sustainability 2Barcelona Declaration 2008: Challenges and Pathways to Earth Sustainability 3Barcelona Declaration 2008: Challenges and Pathways to Earth Sustainability 4Genetic finding implicates innate immune system in major cause of blindness 2
...
Mouse monoclonal [CIG 3A11/5] to Cig2 (rating: *****) ( Abpromise for all tested applications)....
Rabbit polyclonal to CAMK 1D beta ( Abpromise for all tested applications). entrezGeneID: 57118 SwissProtID: Q5SQQ7...
Goat polyclonal to HNF4 ( Abpromise for all tested applications). Antigen: Synthetic peptide: RLSKTLVDMDMADY (Human) N terminal. Entrez GeneID: 3172 Swiss Protein ID: P41235...
Biology Products: