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Diamyd Medical AB : Diamyd broadens the diabetes portfolio

05/14/2013 | 10:50am US/Eastern
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Diamyd Medical has concluded a new exclusive licensing agreement with the University of California in Los Angeles (UCLA) relating to a patent portfolio for the therapeutic use of GABA (gamma-aminobutyric acid) in connection with type 1 diabetes and other inflammatory disorders such as type 2 diabetes, metabolic syndrome and rheumatoid arthritis. The agreement covers, for example, one patent application for a combination therapy including GABA and GAD, which is the active substance in the company's diabetes vaccine, Diamyd®. Professors Tian and Kaufman at UCLA have shown that GABA in combination with GAD acts synergistically in an animal model of type 1 diabetes and that GABA alone can ameliorate type 2 diabetes and rheumatoid arthritis.

Aside from being an important neurotransmitter in the central nervous system, GABA is believed to have an anti-inflammatory effect and the ability to boost insulin sensitivity. GABA and GABA receptor agonists can thus potentially be used to treat inflammation-related conditions, such as both type 1 and type 2 diabetes, metabolic syndrome and rheumatoid arthritis.

The dominating hypothesis among diabetes researchers today is that the key to curing type 1 diabetes is to simultaneously tackle the disease from several fronts by combining various therapeutics or by providing treatment before onset of the disease. Combination therapies have, for example, played a decisive role in the advancements made in cancer treatment in recent years. Many, and possibly even the majority, of leading scientists also believe that future treatment of type 1 diabetes must involve an autoantigen, such as GAD, which is the active substance in the company's diabetes vaccine, Diamyd®. In the continued development of the diabetes vaccine, the company is thus focusing on combining treatment with Diamyd®with other therapeutics and/or treating earlier in the disease process to achieve a strong beta-cell preserving effect.

Drs. Jide Tian and Daniel Kaufman at the Department of Molecular & Medical Pharmacology at UCLA, as well as other researchers at other institutions, have shown that activation of GABA receptors on white blood cells can impede the development of type 1 diabetes, insulin resistance and rheumatoid arthritis in animal models. Combination therapy with GABA and GAD has been shown to act synergistically and, for example, to prolong the survival of transplanted insulin producing beta cells in type 1 diabetes animal models (Tian et al. PLoS One 2011; 6(9):e25337). It is thus relevant to examine whether GABA treatment can boost the beta-cell preserving effect of the company's GAD-based diabetes vaccine to such an extent that market approval for the diabetes vaccine can be secured. If the combination therapy and the patent application for it are approved, patent protection for the company's diabetes vaccine Diamyd®would be indirectly obtained until about 2030.

Diamyd has independently pursued the development of the diabetes vaccine to global Phase III trials and delivered one of Sweden's largest biotech agreements ever. Two Swedish researcher-initiated Phase II trials of Diamyd®are currently in progress. In February 2013, a clinical study by the name of DIABGAD-1 was launched, in which the diabetes vaccine Diamyd®is being combined with relatively high doses of vitamin D and the anti-inflammatory drug ibuprofen. The purpose of the treatment is to preserve the body's own ability to produce insulin and control the blood sugar level in children and adolescents newly diagnosed with type 1 diabetes. About a third of the planned 60 participants have already been enrolled in the study.

A study is also under way to evaluate whether Diamyd®can prevent type 1 diabetes among children at high risk of developing the disease. The study called DiAPREV-IT includes 50 children from the age of four and was fully enrolled in 2012. The first results are expected to be compiled three years after the last participant was enrolled, thus enabling a presentation in 2015.

For more information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: +46 8 661 00 26. E-mail: press@diamyd.com

About Diamyd Medical
Diamyd Medical is a Swedish diabetes company. The Company was formerly called Diamyd Therapeutics and was spun out from Mertiva AB (formerly Diamyd Medical AB) in April 2013. The Company's primary development project consists of the GAD-based diabetes vaccine Diamyd®for the treatment and prevention of autoimmune diabetes. Two Swedish researcher-initiated Phase II studies with Diamyd®are ongoing. One study evaluates whether the diabetes vaccine can prevent type 1 diabetes in children who are at high risk of developing the disease and one study evaluates whether Diamyd®in combination with relatively high doses of vitamin D and ibuprofen can preserve the body's own ability to control the blood sugar level in children and adolescents newly diagnosed with type 1 diabetes.

Diamyd Medical also has holdings in the gene therapy company Periphagen Holdings, Inc. (US).

Diamyd Medical intends to list the Company's shares on NASDAQ OMX First North in mid-May 2013. Further information is available on the Company's website: www.diamyd.com.

Diamyd Medical AB (publ)
Karlavägen 108, SE-115 26 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com. Reg. no: 556242-3797.

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