The technology, IVE (in-vivo encapsulation) is considered as a major advance in insulin delivery, promising to greatly enhance insulin compliance among diabetes sufferers, particularly those who currently require multiple daily insulin injections.
IVE is a physio-chemically triggered drug delivery system within the gastrointestinal tract designed to overcome variables related to membrane permeability, enzymatic degradation, physical barriers, digestive states, hydration status, transit and peristaltic movement.
Diabetes is fast reaching epidemic proportions. An estimated 180 million people around the world suffer from diabetes and experts believe the number could reach 300 million within 20 years, as an obesity epidemic triggers more cases of type 2, or adult-onset, diabetes.
Based on animal experiments, administering the IVE formulation into the GI lumen, the in-vivo encapsulated particles are spontaneously generated and identified along with the insulin peak in the blood stream of the hepatic portal vein.
Additionally, Frank Leung, Coremed's founder and president announced the introduction of CGC, a proprietary, water-soluble, site-specific gel capsule technology that can tolerate high water-content formulation.
In conjunction with Coremed's development of its Intesulin oral insulin, both IVE and CGC were invented in its laboratory.
A small series of "proof-of-principle" human trials of its oral insulin "Intesulin" is currently in progress. Trial 1 will be compared to Trial 2, which uses IVE.
A selection of companies are trying to bring non-injectable formulations of insulin to the multibillion dollar insulin market, with the first commercial launch of a product, Generex Biotechnology's Oral-Lyn, taking place in Ecuador in May this year.
This formulation is delivered via an inhaler type device but is actually absorbed into the bloodstream through the buccal mucosa, with no lung deposition.
Other inhaled insulins, which are in Phase III clinical development are produced by Eli Lilly/Alkermes and Novo Nordisk/Aradigm.
Approximately 22.5 million people suffer from diabetes in Europe alone, with type 2 diabetes accounting for 85-95 per cent of all diagnosed cases.