English Swedish
Published: 2009-12-14 08:26:39 CET
Mertiva
Company Announcement
Diamyd® vaccine approved for studies in children down to 3 years of age in the US
Diamyd Medical reports today that the United States Food and Drug
Administration
(FDA) has approved the experimental use of Diamyd® vaccine in
children as young 
as 3 years of age in the TrialNet GAD study, enrolling 126
new onset type 1     
diabetes patients in North America.                     
                       

The TrialNet GAD study, conducted by an
international network of leading        
pediatric and adult endocrinologists
and immunologists, has previously enrolled 
new onset type 1 diabetes patients
from 16 to 45 years of age but is now allowed
by the FDA to enroll and
administer the Diamyd® vaccine to children as young as 
3 years of age.       
                                                         

“This is very
encouraging news,” says Elisabeth Lindner, CEO and President at   
Diamyd
Medical. “The approval to enroll small children in the TrialNet study is

based on an FDA review of safety data from our ongoing Phase III trials and  
  
further supports that the Diamyd® vaccine's safety profile is strong.”     
    

The TrialNet study is a double-blind, randomized, placebo-controlled
trial,     
which aims to enroll a total of 126 new onset type 1 diabetes
patients at 16    
TrialNet sites in the US and Canada. One third of the
participants will receive 
3 injections with the Diamyd® vaccine, one third
will receive 2 injections with 
the Diamyd® vaccine and one third will receive
placebo (inactive drug). The     
purpose of the study is to determine whether
the Diamyd® vaccine will preserve  
the body's ability to make its own insulin
to help control blood sugar.         

The trial also includes extensive
immunological studies to clarify the mechanism
of action of Diamyd® and to
evaluate the correlation between the clinical and   
immunological outcomes of
Diamyd® treatment in new onset type 1 diabetes        
patients.              
                                                        

Diamyd Medical has
approved the protocol and has executed a Clinical Trial      
Agreement with
the National Institute of Diabetes and Digestive and Kidney      
Diseases,
part of the US National Institutes of Health, to supply
clinical-grade
material (i.e. Diamyd® and placebo) for this trial. TrialNet is
sponsored by the
National Institutes of Health and supported by Juvenile
Diabetes Research       
Foundation International and the American Diabetes
Association.                 


For more information, please contact:       
                                   
Elisabeth Lindner, President and CEO
Diamyd Medical AB (publ.)                  
Phone: +46 8 661 0026             
                                             

For pictures and press
material, please contact:                                
Andreas Ericsson,
Diamyd Medical AB (publ.)                                    

andreas.ericsson@diamyd.com                                                  
  
Phone: +46 8 661 0026                                                      
    


About Diamyd Medical                                                 
          
Diamyd Medical is a Swedish diabetes company focusing on the
development of     
pharmaceuticals for the treatment of autoimmune diabetes
and its complications. 
The company's most advanced project is the GAD-based
drug Diamyd® for type 1    
diabetes. Phase III trials for this drug are in
progress in both Europe and the 
US. In addition, the company has initiated
clinical studies in the US in the    
area of chronic pain, using its Nerve
Targeting Drug Delivery System (NTDDS).   
The company has also out-licensed
the use of GAD for the treatment of           
Parkinson's disease. The
company currently has three clinical-phase products.   

Diamyd Medical has
offices in Sweden and in the US. Shares are listed on Nasdaq 
OMX in Stockholm
(ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)        
administered
by the Pink OTC Markets and the Bank of New York Mellon (PAL).     
Further
information is available on the company's website: www.diamyd.com.     


This information is disclosed in accordance with the Swedish Securities
Markets 
Act, the Swedish Financial Instruments Trading Act, or the
requirements stated  
in the listing agreements.                              
                       


Diamyd Medical AB (publ.)                         
                             
Linnégatan 89 B, SE-115 23 Stockholm, Sweden.
Tel: +46 (0)8 6610026, Fax: +46   
(0)8 661 63 68                             
                                    
E-mail: info@diamyd.com. VAT no:
SE556530-142001.
 


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