Type 1 diabetes is an inflammatory autoimmune disease where the insulin-producing cells are destroyed.
A cure for the disease requires: 1) treatment of the inflammation; 2) abrogating of the autoimmunity and 3) an increase in the number of insulin-producing cells.
Diamyd Medical has advanced its positions on all of these fronts.
1) In a number of different clinical trials, we are treating the inflammation with GABA, ibuprofen and vitamin D, and also suppressing the immune system with etanercept.
2) For abrogation of the autoimmune component, we have access to the world’s most advanced candidate for Antigen Based Therapy, namely our own diabetes vaccine Diamyd®. This has shown significant and clinically relevant effects in preserving insulin-producing capacity in several European Phase III study sub-groups. More than 1,000 patients have participated in Diamyd®® trials, which has generated an excellent safety database for the diabetes vaccine.
Scientists from the University of California, Los Angeles (UCLA), have shown that GABA together with relevant autoantigens may have a general synergistic effect for treatment of autoimmune diseases. This opens up for potentially tremendous opportunities. Thus far, reports have shown that GABA combined with GAD or proinsulin act synergistically in animal models for type 1 diabetes. Approved patents that Diamyd Medical licenses protect the use of these combinations.
3) The Company has invested in the stem cell company Cellaviva with the aim of stimulating development with regard to the ability to increase the insulin-producing cell mass. We believe that in the future, autologous or close relatives’ stem cells can be differentiated into insulin-producing cells and, thereby offer a final cure even for those who have had type 1 diabetes for a long time.
Gluten intolerance or celiac disease – is an area related to type 1 diabetes. The genetic traits that give high risk for developing type 1 diabetes are the same that give high risk for celiac disease. Treatment with Gliadin and gliadin derivatives have demonstrated positive results in animal models for type 1 diabetes as well as for celiac disease. For this reason, our Company recently licensed a patent that protects the use of Gliadin for the treatment or prevention of type 1 diabetes, and also filed a preliminary patent application as protection for the use of GABA in combination with Gliadin for the treatment of celiac disease.
These have come to comprise patent claims for the treatment of disorders beyond type 1 diabetes, such as celiac disease, type 2 diabetes, metabolic syndrome and autoimmune diseases in general.
The Company is fully funded into 2017 at current activity levels. We hope that our stem cell investment in Cellaviva will have reached profitability by then. The holding in the medical devices company Companion Medical may possibly have led to a positive cash flow by 2018. Our focus right now is to seek a financially strong partner for our drug projects, and success with this should lay the foundation for a new important and profitable Swedish diabetes company.
At the time of writing, we have already entered November – partway into our new fiscal year. So far, collaboration discussions are ongoing with Big Pharma, and possibly new investigator-financed studies are being prepared. New results from the pilot study with the Diamyd® diabetes vaccine, ibuprofen and vitamin D are expected in 2015.
Thank you for your interest and support in our fight against diabetes!
Stockholm, November 4, 2015
President and CEO Diamyd Medical AB (publ)