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:7/31/2014)... 2014  According to data released today by the ... monthly Medicare Part D premium is expected to remain ... originally projected, the Pharmaceutical Care Management Association (PCMA) said. ... be a bright spot in American health care. By ... and using cutting edge, cost-saving tools like pharmacy networks ...
(Date:7/31/2014)... , July 31, 2014  Sorrento Therapeutics, Inc. (NASDAQ: ... Mr. Amar Singh , Chief Business Officer and Executive ... natural causes on July 30. "Sorrento is deeply ... and colleague. Our immediate thoughts go to Amar,s family and ... Chief Executive Officer. Mr. Singh joined Sorrento ...
(Date:7/31/2014)... Calif., July 31, 2014 STAAR Surgical Company ... and marketer of implantable lenses and delivery systems for ... ended July 4, 2014 of $20.0 million, a 10% ... of 2013. On a constant currency basis, revenues grew ... the second quarter of 2013.  The effect of foreign ...
Breaking Medicine Technology:Sorrento Announces the Unexpected Death of its Chief Business Officer 2STAAR Surgical Reports 10% Second Quarter Revenue Growth 2STAAR Surgical Reports 10% Second Quarter Revenue Growth 3STAAR Surgical Reports 10% Second Quarter Revenue Growth 4STAAR Surgical Reports 10% Second Quarter Revenue Growth 5STAAR Surgical Reports 10% Second Quarter Revenue Growth 6STAAR Surgical Reports 10% Second Quarter Revenue Growth 7STAAR Surgical Reports 10% Second Quarter Revenue Growth 8STAAR Surgical Reports 10% Second Quarter Revenue Growth 9STAAR Surgical Reports 10% Second Quarter Revenue Growth 10STAAR Surgical Reports 10% Second Quarter Revenue Growth 11STAAR Surgical Reports 10% Second Quarter Revenue Growth 12STAAR Surgical Reports 10% Second Quarter Revenue Growth 13STAAR Surgical Reports 10% Second Quarter Revenue Growth 14STAAR Surgical Reports 10% Second Quarter Revenue Growth 15STAAR Surgical Reports 10% Second Quarter Revenue Growth 16STAAR Surgical Reports 10% Second Quarter Revenue Growth 17STAAR Surgical Reports 10% Second Quarter Revenue Growth 18STAAR Surgical Reports 10% Second Quarter Revenue Growth 19STAAR Surgical Reports 10% Second Quarter Revenue Growth 20STAAR Surgical Reports 10% Second Quarter Revenue Growth 21STAAR Surgical Reports 10% Second Quarter Revenue Growth 22STAAR Surgical Reports 10% Second Quarter Revenue Growth 23STAAR Surgical Reports 10% Second Quarter Revenue Growth 24STAAR Surgical Reports 10% Second Quarter Revenue Growth 25STAAR Surgical Reports 10% Second Quarter Revenue Growth 26STAAR Surgical Reports 10% Second Quarter Revenue Growth 27STAAR Surgical Reports 10% Second Quarter Revenue Growth 28STAAR Surgical Reports 10% Second Quarter Revenue Growth 29STAAR Surgical Reports 10% Second Quarter Revenue Growth 30STAAR Surgical Reports 10% Second Quarter Revenue Growth 31
... 9th, the Hooters of Orange Park is hosting a car wash ... begins at 10 AM at the Hooters of Orange Park located ... 215-5858. All donations from the car wash will go toward the ... Hooters restaurant in the country is raising money through various charitable ...
... Taking a Vitamin with Folic Acid Before PregnancyWHITE PLAINS, ... supplements for at least one year before they become ... baby by half, according to research published this week ... folate supplementation of at least one year to reduced ...
Cached Medicine Technology:Taking Folic Acid for a Year Before Pregnancy May Reduce Risk of Preterm Birth 2
(Date:7/31/2014)... Coral, FL (PRWEB) July 31, 2014 ... held a charity yard sale to benefit Habitat for Humanity. ... over $650 was raised with 100% of the proceeds donated ... of the items not sold at the event were donated ... 31 Willis Road, North Fort Myers, Florida 33903. , ...
(Date:7/31/2014)... Steven Reinberg HealthDay ... -- Many obese and overweight kids don,t see themselves ... impossible, researchers report. In a new study, 27 ... than 3 percent overestimated it. About 25 percent of ... overestimated it, according to the study. "Efforts to ...
(Date:7/31/2014)... July 31, 2014 (HealthDay News) -- With the World ... West African Ebola outbreak has risen to 729, ... Thursday issued a travel warning for,the region. The ... to the affected countries -- Guinea, Liberia and Sierra ... that Ebola is worsening in West Africa," CDC Director ...
(Date:7/31/2014)... and others reporting cognitive difficulties after a head injury ... is it really a concussion? A new study published ... of the same symptoms are common to concussions and ... collectively as cervical/vestibular injuries. , The research was based ... of whom were professional athletes who were being ...
(Date:7/31/2014)... 2014 Joseph M. Lee, M.D., M.S., ... (CDHV), a leading provider of quality cardiovascular and internal ... Dr. Lee is a board certified cardiologist with ... In addition to his position at CDHV, Dr. Lee ... Hospital/ Columbia University Medical Center. Dr. Lee is board ...
Breaking Medicine News(10 mins):Health News:Rich Dad Education Charity Yard Sale to Benefit Habitat for Humanity of Lee and Hendry Counties a Success 2Health News:1 in 4 U.S. Kids Underestimate Their Weight, Study Finds 2Health News:1 in 4 U.S. Kids Underestimate Their Weight, Study Finds 3Health News:CDC Issues Travel Warning as West Africa Ebola Outbreak Worsens 2Health News:Is it really a concussion? Symptoms overlap with neck injuries so diagnosis is tough call 2Health News:Is it really a concussion? Symptoms overlap with neck injuries so diagnosis is tough call 3Health News:ColumbiaDoctors of the Hudson Valley Welcomes Joseph M. Lee, M.D., M.S., R.P.V.I. 2Health News:ColumbiaDoctors of the Hudson Valley Welcomes Joseph M. Lee, M.D., M.S., R.P.V.I. 3
... close relatives proposed , , FRIDAY, Sept. 7 (HealthDay News) ... close relatives of people with coronary heart disease could ... Scottish researchers say. , "If you want primary prevention, ... groups with high risk," explained Dr. Jill Pell, professor ...
... Sept. 7 A group of golfers received,quick and ... surprising,natural remedy. Created by Earth,s Balance, Golfers Rx provided ... golfers with a week,or more of constant itching. ... the microscopic,oak leaf gall mite, also known as the ...
... G.,Rendell has proclaimed Sept. 9 - 15 as "Senior ... play in the lives of older,Pennsylvanians., "Senior community ... for older adults," said Governor Rendell. "The more than ... to stay active,and healthy, continue learning, share experiences and ...
... Inc. (NYSE: HB ) today announced its ... This dividend was declared by Hillenbrand,s,Board of Directors ... shareholders of,record as of September 14, 2007. ... organized into two operating companies,serving the health care ...
... or more alcoholic beverages a day may double their ... researchers at the University of Southern California (USC). The ... and is now available online. , This is the ... alcohol and endometrial cancer, says Veronica Wendy Setiawan, assistant ...
... Process, FRESNO, Calif., Sept. 7 Healthcare workers ... Joslin on,Thursday: the union-busting tactics going on at the ... there at risk. The workers instead urged Joslin ... who are interested in forming a union. Workers,could then ...
Cached Medicine News:Health News:Family History Has Strong Effect on Cardiac Risk 2Health News:Family History Has Strong Effect on Cardiac Risk 3Health News:Big Relief for Tiny Itch Mites Found in All Natural Spray Remedy 2Health News:Governor Rendell Proclaims Sept. 9-15 as 'Senior Community Center Week' 2Health News:Frequent alcohol consumption increases cancer risk in older women 2Health News:Hospital Workers: Management Threatens Patient Care 2
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Medicine Products: