The Promise of Islet Cell Regeneration
Transition's gastrin-based therapies offer a new hope and a chance to live a "normal" life for millions of diabetes patients who are dependent on daily insulin injections and strict diet regimens. They have the potential to reduce or eliminate the need for regular insulin injections for months or even years by regenerating the body's own insulin-producing cells with a short-course treatment. The potential market size in the U.S. alone is estimated to be over US$16 billion.
Gastrin plays a key role in islet beta-cell differentiation and regeneration
Transition's gastrin-based therapies culminate gastrin's ability to regenerate the body's own insulin-producing cells (islet beta cells in the pancreas). Gastrin can also synergize with other agents that can regulate blood glucose such as GLP-1 or DPP-IV inhibitors to correct hyperglycemia in diabetes patients.
TT-223 + EGF analogue (E1-I.N.T.™)
Clinical Development
Transition has completed two exploratory Phase IIa clinical trials with the first regenerative therapy for diabetes, E1-I.N.T.™, in type 1 and type 2 diabetes patients. The primary objective of these trials was to evaluate the safety, tolerability and efficacy of daily treatments of TT-223 + EGF analogue for 28 days with a 6-month follow-up period.
In type 2 diabetes patients, the gastrin-based therapy showed sustained reductions in blood glucose control parameters, including glycosylated hemoglobin (HbA1c), during the 6-month follow-up period. The levels of HbA1c reflect blood glucose control over time. By the post-treatment month 5, HbA1c levels in E1-I.N.T.™-treated patients decreased by an average of 1.21% (p<0.05) from baseline while HbA1c levels in placebo patients increased by an average of 1.00%. Consistent with the changes in HbA1c levels, the data demonstrated decreases in fasting blood glucose levels as well as improvements in glucose tolerance during the follow-up period in patients treated with E1-I.N.T.™ [Link to News]. In terms of safety, E1-I.N.T.™ treatments showed no serious adverse events during the study.
Preliminary data from type 1 diabetes patients treated with E1-I.N.T.™ showed a reduction in daytime insulin usage and a favorable safety profile when the therapy was titrated to maximal doses. [Link to News].
Other Gastrin-Based Technologies
Clinical Development
Transition has completed two Phase I clinical trials to evaluate TT-223 administration in humans. These clinical studies enable the Company to pursue Phase II clinical trials combining gastrin with other hypoglycemic agents, such as GLP-1 (glucagon-like peptide) analogs and metformin, in the second half of 2007.
Best-in-Class GLP-1 Product
Long-acting analogs of GLP-1 are a new class of diabetes drugs recently approved by the FDA. GLP-1 drugs have been shown to regulate blood glucose; however, they are only approved for a specific population of non-insulin-dependent diabetes patients. Transition's GLP1-I.N.T.™ adds regenerative properties to GLP-1 therapy by combining it with gastrin. This combination has been shown to be significantly more efficacious than GLP-1 alone in restoring pancreatic insulin levels and improving glucose tolerance in multiple diabetic animal models.
About Diabetes
Diabetes is a rapidly growing healthcare problem with more than 18 million diabetics today in the U.S. alone, a number projected to grow to 22 million by 2025. The disease destroys the body's insulin-producing cells (islet beta cells), reducing the amount of insulin available to maintain normal blood glucose levels. Diabetics with the most advanced forms of the disease must give themselves multiple daily insulin injections to compensate for this lack of insulin. Complications from insulin therapy include vascular diseases, kidney failure, amputations and blindness.
Current approaches to treat insulin-dependent diabetes include transplantation of islet beta cells. However, transplantation is rare as each transplant requires islet cells donated from multiple organ donors.
