Type 1 diabetes mellitus is a chronic, life-altering form of diabetes mellitus that results from autoimmune destruction of insulin-producing beta cells of the pancreas, resulting in a reduction and eventually in complete cessation of endogenous (one's own) insulin production. It can be induced by a combination of factors, including genetics, environment, and exposure to certain immune triggers. The cause is not yet fully understood, but significant recent advances have been made and the Vaccine represents a potentially significant advance in the management and treatment of the condition.
T1DM has to date been treated by insulin therapy, where the amount of insulin administered is estimated against expected needs to control blood sugar levels. This is expensive, cumbersome and results in poor outcomes for the patients. Recently, western markets have seen an increased use of pump therapy in T1DM particularly in the US, whereas other developed markets are lagging, and multiple daily insulin injections are still the mode of treatment. None is able to provide continuous normal blood sugar, which is the ultimate goal in diabetes sufferers. A treatment that enables a reduction in or elimination of the need for insulin therapy in the management of the condition is, in the view of the Board, expected to be highly attractive both from patient and health economic perspectives.
Various attempts at developing immunotherapeutic management of T1DM have been attempted in the past, including:
- Immunosuppressive drugs
- Steroid therapy
- Stem Cells
Many of these approaches have been unsuccessful. However, the Company now proposes a new approach to treating this condition that is expected to revolutionise the lives of millions of T1DM patients in the future. DMNoMore founder, Dr Tihamer Orban, is a world-leader in the field of the immunological mechanisms underlying T1DM.
Pharmaceutical companies are fully aware of the potential of an immunological approach to preventing diabetes and realise the major unmet need. Pharmaceutical companies have invested and committed to invest over $1bn to date on licensing deals for product development and clinical studies. Most of the on-going studies use monoclonal antibodies that non-selectively suppress T cells to target the small and elusive subset of T cells attacking beta cells in the pancreas. These drugs are not specific to diabetes, and suppress large segments of the immune system, and long-term use may cause serious side effects. The Vaccine, in the view of the Board, potentially is a ground-breaking innovation that is based on in-depth knowledge of the T1DM disease process, utilising immunomodulation rather than immunosuppression.
It is the Board's intention that the Vaccine will be designed to function by boosting the natural balance of the immune system to re-establish immune health. The Vaccine will address the underlying immunological challenge thereby arresting the self-destruction of pancreatic insulin producing cells and preserving insulin self-production.