Navigation Links
Amicus Therapeutics Announces FDA Agreement to Commence Phase 2 Study of AT2220 Co-administered with Enzyme Replacement Therapy for Pompe Disease
Date:3/8/2011

CRANBURY, N.J., March 8, 2011 /PRNewswire/ -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the AT2220 (1-deoxynojirimycin HCI) Investigational New Drug Application (IND).  AT2220 is a pharmacological chaperone in development as a treatment for Pompe disease.  Based on data provided by Amicus, the FDA agreed with the Company's proposal to resume clinical development of AT2220, starting with a new Phase 2 study designed to evaluate the use of AT2220 when co-administered with enzyme replacement therapy (ERT) in subjects with Pompe disease.  The Company expects to commence this study in the first half of 2011 and to report preliminary results in the second half of 2011.

Co-administration of Pharmacological Chaperones with ERTAmicus previously reported promising preclinical data demonstrating that the co-administration of a pharmacological chaperone with ERT has the potential to address key limitations of ERT. The addition of a pharmacological chaperone has been shown to prevent the loss of activity of ERT in the circulation, increase tissue uptake, and increase substrate reduction in multiple disease-relevant tissues. Preclinical proof of concept has been established for Fabry disease and Pompe disease.

About AT2220Data from Phase 1 studies in 72 healthy volunteers demonstrated that AT2220 was generally safe and well tolerated at all doses evaluated with no drug-related serious adverse events. Based on these data and encouraging safety data from preclinical studies, Amicus initiated a Phase 2 clinical trial of AT2220 as a monotherapy treatment in adults with Pompe disease.  The protocol involved initial treatment with a high dose of AT2220.  Two patients enrolled in the trial experienced adverse events categorized as serious and probably related to treat
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Amicus Therapeutics Initiates Phase 2 Clinical Trial Evaluating Amigal™ Co-administered with Enzyme Replacement Therapy
2. Amicus Therapeutics to Present at the 29th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2011
3. Amicus Therapeutics Awarded $500,000 Grant from The Michael J. Fox Foundation for Development of Next-Generation Pharmacological Chaperone to Treat Parkinsons Disease
4. Amicus Therapeutics Announces Third Quarter 2010 Financial Results
5. GSK and Amicus Therapeutics Enter Exclusive Worldwide Agreement to Develop and Commercialize Amigal™ for Fabry Disease
6. Amicus Therapeutics to Host Conference Call and Webcast to Discuss Exclusive Worldwide Agreement with GSK to Develop and Commercialize Amigal™ for Fabry Disease
7. Amicus Therapeutics to Host Its Second Quarter 2010 Financial Results Conference Call and Webcast on August 5, 2010
8. Amicus CEO Represents BIO on Rare Diseases at U.S. Senate Committee on Health, Education, Labor and Pensions Bipartisan Hearing
9. Alzheimers Drug Discovery Foundation Funds Amicus Therapeutics To Advance Pharmacological Chaperone Technology
10. Fenwal Receives FDA Clearance for Amicus(R) Separator With Wireless Connectivity
11. Amicus Therapeutics to Host its First Quarter 2010 Financial Results Conference Call and Webcast on May 6, 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2014)... Del. , Aug. 28, 2014  Rigrodsky & Long, P.A.: ... of Lannett Company, Inc. (NYSE: LCI )? , ... September 10, 2013 and July 16, 2014, inclusive? , ... , Do you want to discuss your rights? ... Special Assistant United States Attorney, Timothy J. MacFall , announces ...
(Date:8/28/2014)... 28, 2014 Reportlinker.com announces that a ... catalogue: Germany Aesthetic Lasers and Energy ... http://www.reportlinker.com/p02343442/Germany-Aesthetic-Lasers-and-Energy-Devices-Market-Outlook-to-2020.html Germany Aesthetic Lasers ... Summary GlobalData,s new report, "Germany Aesthetic Lasers ... key market data on the Germany Aesthetic Lasers ...
(Date:8/28/2014)... 2014 Pharmatech initiated enrollment for its ... game-changing method for matching cancer patients to cancer ... target specific cancers, disease staging, and genetic mutations ... cancer, in the first place. The challenge that ... not be well known to the patient or ...
Breaking Medicine Technology:Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Lannett Company, Inc. 2Rigrodsky & Long, P.A. Announces A Securities Fraud Class Action Lawsuit Has Been Filed Against Lannett Company, Inc. 3Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 2Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 3Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 4Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 5Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 6Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 7Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 8Germany Aesthetic Lasers and Energy Devices Market Outlook to 2020 9Enrollment in Pharmatech's Revolutionary AccessPPM Program Launches 2
... 2012 SERVE-HF, the largest study to investigate ... and outcomes of patients with stable heart failure, has enrolled ... Ltd., is the largest of its kind. This milestone brings ... to its target of approximately 1,250 participants. Principal ...
... N.J., May 18, 2012  Watson Pharmaceuticals, Inc. (NYSE: ... announced today that Paul Bisaro, Watson,s President and Chief ... the Company,s business at the Sanford C. Bernstein 28th ... at 4:00PM Eastern Time at the Waldorf-Astoria Hotel in ...
Cached Medicine Technology:Landmark Sleep Apnea, Heart Failure Study Recruits 1,000th Participant 2Landmark Sleep Apnea, Heart Failure Study Recruits 1,000th Participant 3Watson to Present at the Sanford C. Bernstein 28th Annual Strategic Decisions Conference 2
(Date:8/28/2014)... August 29, 2014 Recently, iFitDress.com, the ... new selection of chic bridesmaid dresses . Included ... items. In addition, all of them are provided at ... , iFitDress.com insists on offering fast and reliable delivery ... what they order in a short time. As is ...
(Date:8/28/2014)... August 28, 2014 Blood's Thicker Than Water ... money and family ties in the heart of the city. ... – a story about how disrespect caused two families to ... many streets. , The Yayo Boyz and the M.O.B. Boyz ... speechless and local onlookers in a silent terror. "Guerrilla," AKA ...
(Date:8/28/2014)... FL (PRWEB) August 28, 2014 Millennium ... use affecting users in the workplace. A recent ... Dependence (NCADD) states that drug abuse is costing ... who use or are addicted to drugs affect their ... activities carry over into the workplace, causing expensive problems ...
(Date:8/28/2014)... government plans its exit strategy from the war, now may ... providing health care to veterans, says a Perspective piece in ... simply go on doing more of the same is to ... cost and population structure pose in the longer run," said ... Clinical Practice, and David Auerbach, from the RAND Corporation, in ...
(Date:8/28/2014)... 2014 The Governor of Yucatán, Rolando ... at a press conference; this event is organized by ... of Economy through the National Microenterprise Financing Program ( ... to the 5th at the Convention Center Yucatan Siglo ... a great responsibility for Yucatan to host the 17th ...
Breaking Medicine News(10 mins):Health News:New Selection of Chic Bridesmaid Dresses Available at iFitDress.com 2Health News:Raymond E. Blake Releases Blood's Thicker Than Water, Based on a True Story 2Health News:Drug Use Causes Problems in the Workplace 2Health News:A VA exit strategy 2Health News:Governor of the State of Yucatan presents the 17th Microcredit Summit 2Health News:Governor of the State of Yucatan presents the 17th Microcredit Summit 3
... COSTA MESA, Calif., Jan. 21 Talk About ... of a $300,000 multi-year grant from the Newport Beach ... of this generous contribution, TACA will launch three new ... program, the addition of an in house advocate to ...
... Nu Skin Enterprises, Inc. (NYSE: NUS ) today ... financial results prior to the market opening on Friday, Feb. ... a conference call with the investment community later that same ... participants can expect to hear management review past results and ...
... uninsuredsteeply rising insurance premiumsemployers cutting healthcare benefits. , ... Diagnoses, and Dollars: Facing the Ever-Expanding Market for ... America,s healthcare industry to task and challenges readers ... Provocative, timely, and comprehensively researched, this book analyzes ...
... Alliance Tech ( http://alliancetech.com ), the leader ... that Carestream Health, Inc., used the company,s ... lead opportunities with attendees at the Radiological ... in Chicago in early December. (Logo: ...
... critical for physicians to understand potential risks when communicating with ... national insurer of physician and surgeon medical liability with 44,000 ... telemedicine liability risks. , ... Napa, ...
... Tenn., Jan. 21 Healthcare Management Systems,Inc.(R) (HMS) announced ... supply a full suite of financial solutions for the ... system will provide much needed,integration for the 26-bed hospital ... also include technology to get them closer to an ...
Cached Medicine News:Health News:Talk About Curing Autism Receives $300,000 Grant From Pacific Life Foundation to Provide Services for Families Affected by Autism in Orange County 2Health News:Alliance Tech's RFID Technology Enhances Carestream Health's Capability to Connect with Key Prospects at RSNA 2Health News:Alliance Tech's RFID Technology Enhances Carestream Health's Capability to Connect with Key Prospects at RSNA 3Health News:The Doctors Company Provides Tips for Physicians to Minimize Risk While Practicing Medicine by Phone or E-mail 2Health News:The Doctors Company Provides Tips for Physicians to Minimize Risk While Practicing Medicine by Phone or E-mail 3Health News:The Doctors Company Provides Tips for Physicians to Minimize Risk While Practicing Medicine by Phone or E-mail 4Health News:Yalobusha General Hospital Selects HMS to Provide Information Technology Infrastructure 2
Inquire...
300 L, Racked, Filtered, Pre-sterilized, 96 tips/rack Recommended for 250 and 300 L pipettes....
... Aerosol barrier tips eliminate false signals ... designed and tested, Promega Barrier Tips ... with amplified nucleic acids (PCR(a)), radioactive ... forensic and serological specimens. , ,Promega ...
Diamond Filter Tips play a critical role in preventing aerosol-borne contamination. Also available sterilized (no need to autoclave) and certified free of detectable RNase, DNase, DNA, RNA, and prote...
Medicine Products: