Therapy (patent pending):
Antigen-based novel approach designed to restore healthy immune tolerance in T1DM patients. With its uniquely T1DM-specific immune modulator approach, our vaccine is designed to change the immune process specific to T1DM autoimmunity beneficially. It is perfectly suited to arrest T1DM autoimmunity, not only in patients with the full blown disease, but in those who have disease that is not yet clinically manifest (pre-Type 1 diabetes). It is non-immune suppressive, thus particularly advantageous for children who are the fastest growing population developing the disease.
This compound is now entering its Phase I/II development after successful pre-clinical data.
(patent for use in T1D autoimmunity pending):
This is marketed as Orencia by Bristol-Myer Squibb for rheumatoid arthritis. A recent Phase 2 clinical trial, initiated and chaired by Tihamer Orban MD, successfully used the drug with a novel application for T1DM. In the trial abatacept significantly slowed down the autoimmunity, preserved self-insulin production and significantly improved blood sugar control. Abatacept beneficially altered the immune cells of T1DM patients and showed no appreciable side-effect even in young children. The drug is now in a clinical trial initiated by Tihamer Orban MD to prevent the development of T1DM. The Company intends to develop the drug for T1DM autoimmunity, for both T1DM patients and pre-diabetics.
This drug is ready for a Phase 3 trial in this new indication.
in combination with an antigen based vaccine (patent granted):
This is marketed as Orencia by Bristol-Myer Squibb for rheumatoid arthritis. This is a combination approach utilising the complementary mode of action of abatacept and a T1DM-specific antigen vaccine to achieve a synergistic effect. The combination is specific for T1DM autoimmunity and designed to be applied as therapy as well as prevention.
This combination product is in preclinical development.