Beta-Cell Regeneration Successful After Two Weeks of Treatments

Two weeks of daily treatments normalize the blood-glucose levels for up to 10 weeks after treatment ends, in addition to increasing beta cell mass 3-fold.

In a recent study, data showed E1-I.N.T.(tm)induces the regeneration of islet cells in a type I diabetes animal model.
In the study, two weeks of daily E1-I.N.T.(TM) treatments were able to normalize the blood-glucose levels of diabetic mice for up to 10 weeks after the end of treatment. In addition, pancreatic beta cell mass was increased threefold and insulin content was increased eightfold in E1-I.N.T.(TM) treated mice compared with pre-treatment levels.

"In these studies, E1-I.N.T.(TM) reversed disease by expanding the number of insulin-producing cells, which led to a significant increase in insulin production. Further, these findings corroborate data seen in other animal models showing that the therapeutic effects of E1-I.N.T.(TM) are sustained long after treatment is completed." said Dr. Tony Cruz, chairman and CEO of
Transition Theraputics.

The article entitled, "Combination Therapy with Epidermal Growth Factor and Gastrin Increases Beta-Cell Mass and Reverses Hyperglycemia in Diabetic NOD Mice" was authored by a group led by Dr. Alex Rabinovitch, the Co-Director
of the Muttart Diabetes Research and Training Centre at the University of Alberta.

The I.N.T.(TM)technology platform, covered by a broad patent portfolio, is based on the discovery that a short course of injections of naturally occurring peptides can regenerate insulin-producing cells in the body.

Two lead I.N.T.(TM) products are currently under development:

1) E1-I.N.T.(TM), a combination of Transition’s epidermal growth factor analogue ("E1") and gastrin analogue ("G1"), has completed two Phase I clinical trials, commenced enrolment for exploratory Phase IIa clinical trials to evaluate efficacy, safety and tolerability of E1-I.N.T.(TM)in type I and type II diabetes patients; and 2) GLP1-I.N.T.(TM), a combination of one of the
leading diabetes drug candidates, Glucagon-Like-Peptide-1 ("GLP-1"), with G1, which is currently in pre-clinical development. Diabetes, Sept. 2005

Just last Friday, Transition Therapeutics announced that patient enrollment has commenced for its regenerative therapy E1-I.N.T. in an exploratory Phase IIa clinical trial in Type II diabetes patients. E1-I.N.T. In the placebo-controlled study, a total of 30 Type II diabetes patients will be enrolled. Twenty patients will receive daily treatments of E1-I.N.T. and ten patients will receive placebo for 28 days. The patients will be followed for six months post-treatment and monitored for islet cell function parameters

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