costs of development and profits from commercialization;
I.N.T.(TM) - Diabetes:
----------------------
- Clinical Data Results:
On June 28, 2007, the Company Announced Final Results from the
Exploratory Phase IIa E1-I.N.T.(TM) Clinical Trial. A 4-Week Therapy
with E1-I.N.T.(TM) Lead to Sustained Reductions in Blood Glucose
Levels for 6 Months Post-treatment in Type 2 Diabetes Patients. In
the E1-I.N.T.(TM) treated group of patients, the mean HbA1c level was
reduced by 0.94% to 1.21% vs. baseline levels in months 2 to 6 post-
treatment. In addition to the HbA1c reductions, the data demonstrated
decreases in fasting blood glucose levels as well as improvements in
glucose tolerance over a six month period following treatment with
E1-I.N.T.(TM). These clinical improvements, including HbA1c
reductions greater than 1% in patients six month post-treatment,
highlight the potential that E1-I.N.T.(TM) therapy could provide
patients significant clinical benefit in excess of six months.
On March 5, 2007, Transition Released Positive Interim Data from E1-
I.N.T.(TM) Clinical Trials in Type 1 and Type 2 Diabetes. Data from
the trial in type 2 diabetes patients demonstrated that E1-I.N.T.(TM)
significantly lowered blood glucose levels for patients using
metformin with/without thiazolidinediones (TZD). In the type 1
diabetes study, 6 of 11 (54%) patients responded to E1-I.N.T.(TM)
therapy, either by decreasing their average daily insulin usage by
more than 20% or reducing their HbA1c levels by 1.2 to 2%. There were
no responders among the placebo group.
- Transition received the remaining US$750,000 of the US$1 million
relating to the amended I.N.T.
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