US NATIONAL INSTITUTES OF HEALTH ANNOUNCES PLANS TO SPONSOR A TYPE 1 DIABETES TRIAL WITH THE EXPERIMENTAL DIAMYD® DIABETES VACCINE Press Release, Stockholm, Sweden, September 21, 2007 - Diamyd Medical AB (www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY) Diamyd Medical announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has posted a planned international clinical study with the Diamyd® GAD-alum diabetes vaccine in 126 new onset type 1 diabetes patients on the NIH clinical trials webpage, www.clinicaltrials.gov. The study is proposed by the NIH/NIDDK sponsored global network TrialNet, a group of the world's foremost experts and key opinion leaders in type 1 diabetes. While the clinical protocol is not completely finalized, and the details of the clinical trial agreement between Diamyd Medical and NIDDK are still being negotiated, the trial is intended to include extensive immunological studies to clarify the mechanism of action and to evaluate the correlation between the clinical and immunological outcomes of GAD-alum Diamyd® treatment in recent onset type 1 diabetes patients. Diamyd Medical has previously announced its plans to initiate a Phase III clinical program for treatment of recent-onset type 1 diabetes patients in the US and Europe. Those plans are continuing and the results from the proposed TrialNet study will complement the findings of Diamyd Medical's planned Phase III studies. About TrialNet TrialNet is an international consortium dedicated to advancing the science of prevention and early treatment of type 1 diabetes. TrialNet is a network of 18 Clinical Centers worldwide with approximately 100 affiliated centers participating as collaborating clinical sites. TrialNet is supported by the United States National Institutes of Health and Department of Health & Human Services, Juvenile Diabetes Research Foundation International, and the American Diabetes Association. About NIH/NIDDK The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary U.S. Federal agency for conducting and supporting medical research. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is one of NIH's 27 Institutes and Centers. NIDDK conducts and supports biomedical research on many of the most serious diseases affecting public health, disseminating research findings and health information to the public. For further information, please contact: Stockholm office Anders Essen-Möller CEO and President +46 8 661 0026 investor.relations@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 life science company developing treatments for diabetes and its complications. The company's furthest developed project is the GAD-based drug Diamyd® for autoimmune diabetes for which Phase III studies are planned to be initiated this year. Diamyd® has demonstrated significant and positive results in Phase II clinical trials in Sweden. GAD65, a major autoantigen 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 may have an important role not only in diabetes but also in several central nervous system-related diseases. Diamyd Medical has an exclusive worldwide license from the University of California at Los Angeles regarding the therapeutic use of the GAD65 gene. Diamyd Medical has sublicensed its UCLA GAD Composition of Matter license to Neurologix, Inc. in Fort Lee, New Jersey for treatment of Parkinson's disease with an AAV-vector. Other projects comprise drug development within therapeutic gene transfer using the exclusively licensed and patent protected Nerve Targeted Drug Delivery System (NTDDS). The company's lead NTDDS projects include using enkephalin and GAD for chronic pain, e.g., diabetes pain or cancer pain. All projects in this field are currently in preclinical phases. 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 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 at www.diamyd.com. 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.
US NATIONAL INSTITUTES OF HEALTH ANNOUNCES PLANS TO SPONSOR A TYPE 1 DIABETES TRIAL WITH THE EXPERIMENTAL DIAMYD® DIABETES VACCINE
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