STOCKHOLM, Sweden, June 10, 2004 (PRIMEZONE) -- 24-month data from Diamyd Medicals (TM) Phase II clinical trial with the diabetes therapeutic Diamyd(TM) were presented today at the American Diabetes Associations (ADA) annual congress in Orlando, USA by Professor Carl-David Agardh, Professor of clinical diabetes research at the University of Lund and Chief of Medical Staff at the University hospital MAS in Malmo. The results show that two injections of 20 micrograms of Diamyd(TM) (alum-GAD) give a positive, long-term effect in the form of increased insulin production and improved blood glucose levels for at least 24 months.
"The message is simple and clear. Administration of Diamyd(TM) increases the numbers of regulatory T cells in the patient group that also shows both improved insulin production and improved glucose levels. A clear immunoregulatory effect is thus demonstrated. The effect is apparent for at least 2 years. These results must now be corroborated through a multinational Phase III clinical trial", says Professor Agardh.
"Diamyd Medical has demonstrated 'proof of concept' with their diabetes therapeutic Diamyd(TM), says Professor David Leslie, of St Bartholomews Hospital in London, England and member of Diamyd's Medical and Scientific Advisory Board. "The improved blood glucose levels that are evident after 24 months are more than necessary for Diamyd(TM) to become a large and important therapeutic agent. It is highly likely that the type of antigen-specific therapy such as that Diamyd(TM) offers can pave the way for prevention of type-1 diabetes, and I hope, as I have previously stated, that the Action-LADA consortium that I head can now be part of the large clinical trials that need to be conducted with Diamyd(TM) in LADA patients on order for the preparation to reach the market."
"The results are extremely exciting. The GAD antigen is a very strong candidate for a new and specific diabetes therapeutic and I hope to be able to be part of the defining studies here in the USA" says Jerry P. Palmer, -- one of North America's most respected diabetes researchers and clinicians, of VA Puget Sound Health Care System, Seattle.
"The importance of retaining endogenous insulin production in diabetes patients has been demonstrated" says Professor Paul Zimmet, of the International Diabetes Institute, Caulfield, Victoria, Australia. Zimmet was one of the first to show that about 10% of type-2 diabetes patients have antibodies against their own insulin producing cells and that these patients would develop at a later stage the requirement for insulin injections (LADA). "We look forward with extreme interest to GAD being used to prevent insulin requirement in LADA patients".
"Diamyd(TM) represents a new and very promising and innovative method of inducing specific protection of the insulin producing beta cells that are attacked during type-1 diabetes and LADA. I am very interested in taking part in the large clinical trials with GAD that must now be conducted" says Professor Paolo Pozzilli, Head of the Endocrinology Clinic, University of Rome, Italy. Pozzilli is a member of "Action-LADA" which is an EU-supported consortium.
Professor Mark Atkinson, University of Florida, Gainesville, USA, one of the pioneers of antigen-specific treatment of diabetes and member of Diamyd's Medical and Scientific Advisory Board was awarded "The 2004 Outstanding Scientific Achievement of the American Diabetes Association" during the congress. Atkinson emphasised during his lecture to several thousand diabetes specialists that it is now 30 years since it was first understood that type-1 diabetes is an autoimmune disease, and that one of the most important advances has been that through measurement of antibody reactivities against GAD it is now possible to predict which individuals will develop the disease. Among other motives for being recipient of the award were that Atkinson's work with specific autoantigens such as GAD have led to these autoantigens being used in clinical trials and that Atkinson's research can be very instrumental in finding a 'cure' for type-1 diabetes. "The results from the Diamyd study show a clear positive effect and that it is possible to specifically modulate the immune system using an autoantigen. I wish Diamyd Medical all success in their innovative work in finding a 'cure for Diabetes' and I have high hopes today that they will succeed."
"Professor David Agardh's presentation in Orlando was met with much interest from the assembled scientific experts. We will now continue the commercial development of Diamyd" , says Anders Essen-Moller, CEO for Diamyd Medical. "Several important prerequisites for this to happen have now been met: 1) Diamyd(TM) has been shown to be safe; 2) Diamyd(TM) has been shown to effect the immune system so that insulin production and blood glucose levels are improved; and 3) Diamyd(TM) has been shown to have an effect for at least 2 years."
The therapeutics primary target group is considered to be adult diabetics with GAD antibodies. The market for this patient group alone is estimated to be several billion kronor per year. Further applications are considered to be 1) preservation of beta cells in new onset type 1- diabetes patients; 2) in conjunction with transplantation of insulin producing cells or with stem cell therapy to prevent the autoimmune inflammation that caused the initial damage from reoccurring; 3) to prevent type 1-diabetes in children and youths that have not as yet developed the clinical disease. This can mean that the method for identifying individuals at risk of developing type-1 diabetes through measurement of GAD-specific antibodies is extremely important. Diamyd Medical develops and markets a diagnostic kit for this purpose.
About Diamyd Medical:
Diamyd Medical is listed in the Stockholm stock exchange O-lista (DIAMb, SSE). The company's business strategy is to identify and develop pharmaceutical projects up to and including Phase II clinical trials. The company has licensed the worldwide rights for therapeutics concerning the gene for Glutamic Acid Decarboxylase 65 (GAD). The granted patent protects GAD rights until 2021 in the USA. GAD plays an important enzymatic role in conversion of the excitatory amino acid glutamate to the inhibitory neurotransmitter GABA and is considered the most important autoantigen involved in development of type-1 diabetes. At present, Diamyd Medical conducts several GAD-based developmental projects in the fields of metabolic and neurological diseases. The most advanced project is a therapeutic for insulin-dependent diabetes. Positive 24 month results from a Phase II clinical trial with this preparation are reported.
For further information contact: Anders Essen-Moller, Diamyd Medical AB (publ), Tel: 08-661 00 26, 661 12 25, fax: 08-661 63 68 orvia e-post: info@diamyd.com.
No guarantee can be given regarding authenticity of the opinions of historical or future results.
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