DIAMYD® DIABETES VACCINE APPROVAL TO START PHASE III IN EU
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Posted by Tiemslot on 02:49:33 2008/03/19
Diamyd Medical: DIAMYD® DIABETES VACCINE RECEIVES APPROVAL TO START PHASE III TRIALS IN EUROPE
DIAMYD® DIABETES VACCINE RECEIVES APPROVAL TO START PHASE III TRIALS IN
EUROPE
Press Release, Stockholm, Sweden, March 19, 2008 Diamyd Medical AB
(www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that the Swedish Medical Products Agency
(MPA) has approved the Company's application to commence Phase III
studies with the therapeutic diabetes vaccine Diamyd®.
"I am extremely glad that we now can offer our recently diagnosed type 1
diabetes patients the possibility to participate also in the European
study", says Professor Johnny Ludvigsson, Linköping, Sweden, Principal
Investigator for the study.
Diabetes teams from approximately 20 Swedish pediatric clinics will meet
in Linköping, Sweden, on April 4 to go through details for the study,
which will comprise 306 new onset type 1 diabetes patients. Diamyd
Medical is planning to file clinical trial applications in another 3-4
European countries and include additionally 20 clinics in the study.
"The approval from the Swedish MPA is another important step in the
development of Diamyd® towards the market", says Elisabeth Lindner,
President and CEO of Diamyd Medical. "Last week we received
authorization from the FDA to start a parallel Phase III trial in the
US, and together with TrialNet's planned study in the US, the interest
in Diamyd is strong. We receive daily inquiries from parents of patients
wanting to participate in our studies".
For further information, please contact:
Stockholm office
Elisabeth Lindner
CEO and President
+46 8 661 0026
elisabeth.lindner@diamyd.com
Stockholm office
Anders Essen-Möller
Chairman
+46 8 661 0026
anders.essen-moller@diamyd.com
Pittsburgh office
Michael Christini
President
+1 412 770 1310
michael.christini@diamyd.com
Diamyd Medical AB (publ). Linnégatan 89 B, SE-115 23 Stockholm, Sweden.
Tel: +46 8 661 00 26, fax: +46 8 661 63 68 or E-mail: info@diamyd.com.
VATno: SE556530-142001.
About Diamyd Medical
Diamyd Medical is a biopharmaceutical company focusing on development of
pharmaceuticals for treatment of diabetes and its complications. The
company's most advanced project is the GAD-based drug Diamyd® against
autoimmune diabetes. Diamyd® has demonstrated significant and positive
results in Phase II clinical trials.
GAD65, a major auto antigen in autoimmune diabetes, is the active
substance in Diamyd®. GAD65 is also an enzyme that converts the
excitatory neurotransmitter glutamate to the inhibitory transmitter
GABA. In this context, GAD is expected to play an important role not
only in diabetes but also in several CNS-related diseases. Diamyd
Medical has an exclusive worldwide license from the University of
California, Los Angeles, regarding the therapeutic use of the GAD65
gene.
Diamyd Medical has sublicensed its UCLA GAD license to Neurologix, Inc.,
New Jersey, for treatment of Parkinson's disease.
Other projects comprise drug development within therapeutic gene
transfer using the exclusively licensed and patent protected
NTDDS-system (Nerve Targeting Drug Delivery System). The company's lead
NTDDS projects include enkephalin and GAD for treatment of chronic pain
such as diabetes pain and cancer pain.
Diamyd Medical has offices in Stockholm, Sweden and Pittsburgh, PA. The
Diamyd Medical share is quoted on the Stockholm Nordic Exchange in
Sweden (NOMX ticker: DIAM B) and also on the OTCQX-list in the United
States (ticker: DMYDY) administered by the Pink Sheets and the Bank of
New York (PAL). Further information is available on the company's web
site; www.diamyd.com.
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