DIAMYD EXECUTES AGREEMENT WITH US NATIONAL INSTITUTES OF HEALTH FOR A TYPE 1 DIABETES TRIAL WITH THE EXPERIMENTAL DIAMYD® DIABETES VACCINE
Press Release, Stockholm, Sweden, November 22, 2007 – Diamyd Medical AB (www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that it has executed a Clinical Trial Agreement with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for a planned clinical study with the Diamyd® GAD-alum diabetes vaccine in 126 new onset type 1 diabetes patients. The clinical study will be conducted by the NIDDK-sponsored consortium Type 1 Diabetes TrialNet. Under the terms of the agreement, Diamyd Medical will supply clinical-grade material (i.e. Diamyd® and placebo) for the trial.
As previously announced, the trial will 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. Such a detailed analysis may provide important information into the ability of Diamyd® to protect islet cells from autoimmune attack as a mechanism for maintaining insulin production. Additionally, the immunological data may prove beneficial for designing future diabetes prevention studies.
“We are extremely excited to be working with NIDDK and TrialNet on this new Diamyd® clinical study,” stated Anders Essen-Möller, CEO of Diamyd Medical. “TrialNet is uniquely positioned to conduct clinical studies and to evaluate the molecular and cellular mechanisms of potential diabetes therapies. The insights expected from this trial should prove very valuable for Diamyd®, the scientific community and for 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. Applications for allowance to conduct the studies are planned to be submitted to FDA in the US in December and then to the regulatory authorities in Europe.
About TrialNet
TrialNet is an international consortium dedicated to advancing the science of prevention and early treatment of type 1 diabetes. TrialNet is a worldwide network of 18 Clinical Centers with 16 major affiliates and approximately 150 additional 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.