Navigation Links
AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)
Date:10/3/2008

AMSTERDAM, October 3 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that it intends to incorporate additional data into the Marketing Authorization Application (MAA) for Glybera(R) for Lipoprotein Lipase Deficiency (LPLD), a seriously debilitating and potentially lethal disease.

The data obtained so far from two phase II clinical studies (22 patients in total) demonstrate that Glybera(R) is well-tolerated (no drug-related severe adverse events and no dose-limiting toxicity). Positive effects were shown on fat (triglyceride) metabolism, resulting in an almost complete disappearance of pancreatitis during both the immediate 12-week study observation period and the long-term follow-up (up to 3 years post-injection), as well as the disappearance or reduction of fat accumulations in skin or retina. All patients reported gain of energy and in the two patients that had diabetes, a reduction of insulin resistance was observed, leading to a reduction of their diabetic medication.

In consultation with the Rapporteur countries, Germany and the United Kingdom, of the European Medicines Agency (EMEA) and Health Canada, AMT has decided to expand the clinical experience and to augment the Marketing Authorization Application (MAA) with an additional 16-patient study that will investigate the broader impact of this gene therapy on additional aspects of lipid metabolism. Preparations for this study to be conducted in Canada will start immediately. Submission of the MAA to the EMEA is foreseen in the second half of 2009. In line with the guidance given in the half year financial report, the Company's cash position allows the completion of this study to be done with existing financial resources.

AMT has developed Glybera(R) as a cure for patients with the rare genetic disorder, LPLD. Because of a defective gene, LPLD patients do not produce an enzyme that normally break
'/>"/>

SOURCE Amsterdam Molecular Therapeutics B.V
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
2. Genta Incorporated Announces Third Quarter 2007 Financial Results
3. Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights
4. Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
5. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
6. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
7. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
8. PTC Therapeutics Announces Additional Results from Phase 2 Study of PTC124 in Duchenne Muscular Dystrophy
9. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
10. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
11. Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... DULLES, Va. , April 17, 2015 ... and distribution of radiopharmaceuticals, announced today that it has ... IBA Molecular North America, Inc. (IBAM NA), to Illinois Health ... continue to operate as an independent company headquartered in ... well positioned to take advantage of new product and ...
(Date:4/17/2015)... -- TWi Pharmaceuticals, Inc. ("TWi", Stock Ticker:4180.TT) today announced ... , has obtained state sales licenses from all ... in close contact with the major nationwide retail pharmacy ... label specialty generic products sold through these nationwide pharmacy ... According to IMS Health, the U.S. pharma market ...
(Date:4/16/2015)... Calif. , April 16, 2015  Alexza Pharmaceuticals, Inc. ... quarter ended March 31, 2015 on Wednesday, May 6, 2015, ... will also host an investor conference call and live webcast ... provide a company update and discuss the financial results.  ... to www.alexza.com , under the "Investors" link.  Please log ...
Breaking Medicine Technology:Health Care System to Acquire IBA Molecular North America 2Health Care System to Acquire IBA Molecular North America 3Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 2Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 3
... , PRINCETON, N.J. , Feb. 17 ... a late-stage biotechnology company, announced today that it has received ... Polymer Micelle (LPM™) technology for the improved oral delivery of ... entitled "Stabilized Reverse Micelle Compositions and Uses Thereof" covers lipid ...
... EXTON, Pa. , Feb. 16 BioTrends Research Group, ... Feraheme report, the third in a multi-phase ... iron product, Feraheme, through the first six months of product availability. ... Nephrologists and qualitative information from a subset of 15.  The reports ...
Cached Medicine Technology:Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology 2Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology 3Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology 4Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology 5Use of AMAG's Feraheme is on the Rise with 23% of Nephrologists Reporting Use of the Product 2
(Date:4/17/2015)... 2015 Heritage Woods of McLeansboro, a ... Living Week Celebration on April 20 with a day ... mind, body and soul. , The community, which is ... older adults of all incomes, including those on Medicaid, ... Supportive Living Week is observed every April and highlights ...
(Date:4/17/2015)... 2015 Rosetta Radiology is proud to ... their list of diagnostic imaging services. This solidifies them ... the Upper East Side of Manhattan. , The new ... The addition of PET-CT, combined with Rosetta’s state of ... to work with patients through several stages of the ...
(Date:4/17/2015)... California (PRWEB) April 17, 2015 ... Dr. Kevin Sadati of the Gallery of ... Orange County’s top beauty experts. The publication focused ... lift, facial stem cell fat grafting, eyelid surgery, laser ... facial plastic surgery has resulted in thousands ...
(Date:4/17/2015)... April 17, 2015 Florida Hospital Wesley ... and Florida Hospital Carrollwood were all selected as Top ... located in Pasco County, is ranked number one for ... survey, which was conducted in partnership with an independent ... all-private bed hospital that opened in October of 2012 ...
(Date:4/17/2015)... From the day Dr. Todd Phillips founded The ... has empowered young people to create meaningful change in their ... water and the Gospel to all of Liberia by 2020 ... and 27, students, faculty and staff raised $21,000 through the ... and the Good News of Jesus. , During the ...
Breaking Medicine News(10 mins):Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 2Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 3Health News:Orange County Facial Plastic Surgeon Featured in Premier Magazine Focused on Beauty 2Health News:Orange County Facial Plastic Surgeon Featured in Premier Magazine Focused on Beauty 3Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 2Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 3Health News:Tampa Bay Times Selects Florida Hospital Wesley Chapel, Florida Hospital at Connerton Long Term Acute Care and Florida Hospital Carrollwood As Top Workplaces in Tampa Bay 4Health News:The Last Well and Liberty U’s TEN Initiative raises $21,000 to Bring Fresh Water & The Gospel to 7,000 Liberians 2
... Oct. 17 Dr. Prudence Hall,founder of The Hall ... strong,advocate for the overall health of her patients. It ... bioidentical natural hormones,that she started investigating her birth control ... of my twenty year old patients on the,pill, had ...
... food is needed, study suggests , , WEDNESDAY, Oct. 17 ... to blame, research suggests. , Scientists from the University ... dopamine, a brain chemical that helps make eating and ... more food. , "We weren,t studying obesity, per se, ...
... (NDMA) introduces platform that,leverages data contained within enterprise healthcare systems into ... ... costs, ... announced the availability of the NDMA Clinical,Intelligence Platform to all healthcare ...
... "You CAN Eat That! Awesome Food for Kids ... Oct. 17 Cooking for a child with ... separate meals. Cleveland Clinic,Press ( http://www.clevelandclinicpress.org/ ), publishing ... "You CAN Eat That!,Awesome Food for Kids with ...
... workflow and data connectivity for ... Cardiac ... CSCX ), a global leader in advanced cardiac monitoring,and ... Tel RMS(R) 3.0, now has seamless connectivity with LUMEDX,CardioWellness(TM) data ...
... numbers are staggering --,over 20% of people living in ... the impairment or disability which creates dependency and,poverty in ... and political opportunities," says Ron Nabors, Chief,Executive Officer of ... stand up and speak out on the,International Day for ...
Cached Medicine News:Health News:Do Not Take the Pill! Dr. Prudence Hall Tells her Teen and Female Patients 2Health News:Do Not Take the Pill! Dr. Prudence Hall Tells her Teen and Female Patients 3Health News:Genes Might Help Drive Overeating 2Health News:Genes Might Help Drive Overeating 3Health News:NDMA Launches Clinical Intelligence Platform 2Health News:New Cleveland Clinic Press Healthy Cookbook Helps Diabetic Kids 2Health News:Cardiac Science Announces Data Connectivity with LUMEDX 2Health News:Cardiac Science Announces Data Connectivity with LUMEDX 3Health News:Cardiac Science Announces Data Connectivity with LUMEDX 4Health News:CBM USA stands up and speaks out to world leaders on the International Day for the Eradication of Poverty 2
The Urine Legionella Antigen ELISA kit detects the presence of Legionella pneumophila serogroup1 antigen in urine....
Measles IgM ELISA....
Toxoplasma IgG II ELISA...
Herpes Simplex Virus Group IgG....
Medicine Products: