« Return to News | Clinical Intelligence

Amsterdam Molecular Therapeutics shows data supporting role of chylomicron clearance as marker for Glybera efficacy

Friday, May 20, 2011 11:10 AM

Amsterdam Molecular Therapeutics, a company involved in the field of human gene therapy, has results from a long-term efficacy study of Glybera (alipogene tiparvovec) that showed improved chylomicron metabolism could be used as a biomarker for increased lipoprotein lipase (LPL) activity in those patients missing the gene that produces this protein. Glybera is a gene therapy product under development for the treatment of lipoprotein lipase deficiency (LPLD) that is currently under review for marketing approval with the EMA.

A total of 5 LPLD patients were administered Glybera (1x1012 genome copies/kg, IM). At weeks 14 and 52 post-administration, patients were given a test meal with a tracer molecule designed to monitor the breakdown of newly formed chylomicrons in the blood. Prior to therapy, all patients exhibited poor post-meal chylomicron handling as measured by amount seen in the plasma over 9 hours following meal ingestion. After treatment with Glybera, the amount of tracer found was greatly reduced and in each case was completely eliminated within nine hours. The effect was consistent in all patients and sustained as observed at both the 14 and 52 week time points.

 

 

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.