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  Jun 10, 2003  PRNewswire  
 

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:

  1. Intesulin™, an intestinally delivered oral insulin has marked hypoglycemic efficacy at 2 units/kg or less.
  2. Intesulin™ has demonstrated efficacy similar to the methods of insulin delivered by inhalation or injection
  3. Intesulin™ is selectively more effective in diabetic than non-diabetic conditions.
  4. It has prolonged hypoglycemic action for eight hours.
  5. Its extremely small effective dosing volume minimizes potential side-effects.
  6. It is effective in severe diabetic conditions.
  7. Intesulin ™ is formulated using commercial and GRAS materials.
  8. It is stable at room temperature.
  9. Oral insulin does not have the potential pulmonary side-effects and complications
  10. 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.

 
 
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