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Coremed, inc. Announces positive results from animal study of its
Intesulin™ Oral Insulin
Lake Bluff, Illinois, March 10, 2003 -- Coremed, Inc. presented
positive data on its Intesulin™ from the study of diabetic animals,
showing similar efficacy as insulin injection. This is one major
step towards achieving this long-awaited and complicated technology.
Current developments of oral insulin have demonstrated efficacy
requiring doses at least 20-30 units/kg. Coremed’s formulations
provide effective insulin action at 10 units/kg, 5 units/kg and 2
units/kg in diabetic animals. Nine abstracts will be published and
/or presented in the 2003 at the American Diabetes Association and
Endocrine Society annual scientific meetings. Additional data had
been reported in previous scientific meetings from 2000 to 2002.
Intesulin™ mimics the route of transport and mechanism of action
of physiological insulin. Inhaled insulin has been developed as an
alternate to injection method because, to date, efforts on
developing oral insulin have not yet been successful. The efficacy
of inhaled insulin is about 1 unit/kg. Its glucose response follows
a U-shaped curve.
In contrast, Coremed’s Intesulin™ .oral insulin formulation
demonstrated efficacy in diabetic rats at 2 units/kg with a L-shaped
glucose response. Eighth hours after a single dose, the Intesulin’s
blood glucose level was still significantly lower than the placebo.
When compared to the exact dose subcutaneous insulin injection,
Coremed’s Intesulin™ achieved similar glucodynamic effects and
efficacy as injection as defined by the AUC (area under the curve)
glucose.
The total amount of insulin absorbed contains two forms: free
insulin and insulin complexes. The measurable absorbed free insulin
in the portal vein is 15.9% compared to injection method. The
efficacy of Intesulin™ is independent of the insulin concentrations
formulated. There is a marked hypoglycemic action occurs over a wide
range of insulin. The hypoglycemic effect per unit of free insulin
measured in the hepatic portal vein is 54 times greater than the
results from subcutaneous insulin injection.
Diabetic animals absorbed Intesulin ™. much better than
non-diabetic animals by several folds, even in the presence of
diabetic ketoacidosis. Preliminary data suggested that Intesulin ™
may survive the harsh gastric environments, retaining its
glucose-lowering efficacy.
Coremed’s data demonstrated:
- Intesulin™, an intestinally delivered oral insulin has marked
hypoglycemic efficacy at 2 units/kg or less.
- Intesulin™ has demonstrated efficacy similar to the methods of
insulin delivered by inhalation or injection
- Intesulin™ is selectively more effective in diabetic than
non-diabetic conditions.
- It has prolonged hypoglycemic action for eight hours.
- Its extremely small effective dosing volume minimizes
potential side-effects.
- It is effective in severe diabetic conditions.
- Intesulin ™ is formulated using commercial and GRAS materials.
- It is stable at room temperature.
- Oral insulin does not have the potential pulmonary
side-effects and complications
- It is cost-effective.
“We are currently scoring the second strike in our development.”
Dr. Leung, director of its laboratory said, “ The first strike was
our first generation of oral insulin which required 100 to 400
units/ kg dose to achieve efficacy. The second strike of oral
insulin requires 1 to 10 units/kg dose to achieve similar efficacy
of injected and inhaled insulin. In the third strike of our
development, our goal is to excel injected and inhaled insulin both
in their efficacy and pharmacokinetic profiles, with doses at 0.1 to
0.5 unit/kg or less.”
Several major pharmaceutical companies in diabetes care have been
engaged in different stages of evaluating Coremed’s technology.
About Coremed
Founded in 1994, Coremed, Inc., a specialty research laboratory,
is developing transmucosal insulin based on its proprietary
technology, for the treatment of diabetes mellitus. Frank K. Leung,
M.D., F.A.C.E., a Harvard-trained endocrinologist and researcher, is
the director of its laboratory.
To the extent any statements made in this release relate to
information that is not historical these statements are necessarily
forward-looking. As such, they are subject to the occurrence of many
events beyond the company’s control and other uncertainties are
subject to various risk factors that could cause the company’s
actual results to differ materially from those expressed in any
forward-looking statement. |