LAKE BLUFF, Ill., Dec. 29 / PRNewswire / -- Coremed, Inc., has announced that it will soon begin a series of human trials using its Alveair™ insulin pulmonary technology that is inhaled, not injected.

Since its discovery around 80 years ago, insulin dosage is traditionally standardized in "units" measurement. Coremed's Alveair™ pulmonary prototype features a hand-held device that delivers inhaled insulin in units, making it possible for the direct substitution of injectable insulin.

Exclusively dedicated to the development of oral insulin, Coremed, Inc., has conducted some of the most intensive pre-clinical biological trials of oral insulin anywhere, resulting in its published data presented at the American Diabetes Association and the Endocrine Society's annual meetings from 2000 to 2003.

In making the announcement, Frank K. Leung, M.D., F.A.C.E., a Harvard-trained endocrinologist and researcher, who is director of Coremed's laboratory, said plans call for small clinical trials to be conducted at selected hospital-based sites and academic centers. Each will be designed to evaluate the performance of Alveair™ on humans.

Based on Alveair™ insulin's pre-clinical trials, Alveair™ insulin was shown to have comparable efficacy as subcutaneous injection, with excellent insulin bioavailability, long duration of action, and more predictability and less variability in responses than injections, Leung said.

Describing Coremed's technology as "unique and one-of-its-kind," Leung said, "The formulation is completely aqueous soluble, and potentially offers a good safety profile."

A recent research communication published at the 62nd annual American Diabetes Association Scientific Sessions suggested that inhaled insulin may be harmful in lung disease as a result of ventilation-perfusion mismatch, which is concentration-dependent. As demonstrated in Coremed's laboratory, Alveair™ insulin efficacy requires less than one unit/ml concentration, the lowest among the reported literature.

The Alveair™ insulin dosage is in units/kg body weight, similar to the present practice of insulin injections for human use. The hand-held device prototype is capable of delivering any amount between 0.2 to 200 units in one single dose administration The median mass median diameters (MMD) of the vaporized droplet size is 1.9 um (microns).

All steps involving the administering of Alveair™ insulin exactly follow the current clinical practice of insulin injection, including packaging, storage, dosing steps and dosages. The only difference is that humans inhale Alveair insulin, with no need to use a needle.

The manufacturing cost is only a fraction of the leading technology, Leung added.

"Our goal is to develop an alternative insulin delivery route comparable to the insulin injection," Leung said. "We are very pleased with our progress. We have the vision and the potential to be one of the best inhaled insulin technologies on the market, with a good safety profile, and performing like a needle-less syringe."

About Coremed

Founded in 1994, Coremed, Inc., a specialty research laboratory based in Lake Bluff, Il., is developing transmucosal insulin based on its proprietary technology, for the treatment of diabetes mellitus. For more information, visit its web site http://www.coremedusa.com.

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.