Stockholm, March 19, 2008
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".
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.
For further information, please contact:
CEO and President
+46 8 661 0026
+46 8 661 0026
+1 412 770 1310
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: firstname.lastname@example.org. VATno: SE556530-142001.
Disclaimer: This document contains certain "statements" relating to present understandings, future events and future performance, including statements relating to the progress, timing and completion of our research, development and clinical trials; our ability to market, commercialize and achieve market acceptance for product candidates; and our current and future strategic partner relationships. These statements can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to publicly update such statements, whether because of new information, future events or otherwise, nor does Diamyd Medical give any guarantees that the statements, given or implied, are correct. This document is a translation from the Swedish original. No guarantees are made that the translation is free from errors.