LAKE BLUFF, Ill., Jan. 20 / PRNewswire / -- Coremed, Inc., announced positive data from the first human trial of its "needle-less" Alveair™ insulin pulmonary technology. The technology uses a hand-held device that delivers inhaled insulin with the same units as conventionally injected insulin.

A small number of normal humans were involved in the clinical trial. Alveair™ insulin was administered exactly like the current clinical practice of insulin injection. The only difference is that, in this case, humans in the trial inhaled Alveair™ insulin without any need to use a needle.

The trial was administered with a single dose, two periods crossover design, with an in-between washout period. The median mass diameters (MMD) of the vaporized droplet size were 1.9 microns. Statistically significant efficacy was achieved with low sub-unit/kg dosage, comparable to Coremed's pre-clinical data, said Frank K. Leung, M.D., F.A.C.E., a Harvard-trained endocrinologist and researcher, who is director of Coremed's laboratory.

"There was not a single incidence of induced coughing, sneezing, upper or lower respiratory irritations or allergic reactions," Leung said. "Comments such as 'I do not feel anything' were noted. All subjects tolerated the experiments well."

Leung emphasized, however, that the current results should be considered only preliminary.

Based on its research, Coremed has submitted a total of nine abstracts for peer review and presentations at the 64th American Diabetes Association Scientific Session to be held later this year.

Commenting on earlier trials, Leung said, "Based on Coremed's pre-clinical data and published literature, Alveair™ insulin has the most efficacy and the highest insulin bio-availability."

However, of utmost importance in the development of pulmonary insulin are the issues of safety and tolerability, he said. They depend on:

• The physical characteristics of the formulation
• Insulin dosage
• Insulin concentration
• Location of drug deposition
• Recipients

Coremed's pre-clinical data showed that Alveair™ achieves efficacy with the lowest insulin dosage and lowest insulin concentration in the reported literature. It is completely aqueous soluble and is made of GRAS ingredients.

Alveair™ insulin is poised, Leung said, to achieve the best technology of its class.

Founded in 1994, Coremed, Inc., a specialty research laboratory, is developing transmucosal insulin based on its proprietary technology, for the treatment of diabetes mellitus. For more information, visit 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. 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.