Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Diabetes vaccine proceeds with Phase III clinical study

Diamyd Medical : 17 March, 2008  (New Product)
The US FDA has granted Diamyd Medical permission to proceed with a Phase III clinical study in type 1 diabetes patients in the USA with the therapeutic diabetes vaccine Diamyd.
'We are eager to start this study and to be able to offer this promising drug to our newly diagnosed type 1 diabetes patients', says professor Jerry Palmer, University of Washington in Seattle, USA, who will be the lead investigator for the US study.

'We are extremely pleased with this progress,' says Elisabeth Lindner, president and chief executive officer of Diamyd Medical. 'Over the past months we have received dozens of patient inquiries with requests to participate in our Phase III type 1 diabetes studies in the USA and in Europe. It is very satisfying to be able to start the studies now.'

The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within three months of diagnosis. Results of the study will be analysed 15 months after all patients have been enrolled. A parallel Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, these pivotal studies can be used for market registration of the drug.

In a previous Phase II study in young type 1 diabetes patients, Diamyd showed efficacy in preserving the patients' own insulin producing capacity for at least 30 months. No safety concerns have to date been reported in any clinical study with Diamyd.
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo