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Phase I Oral Insulin Trial Shows Macrulin Works LONDON -- June 30, 1997 -- U.K. based pharmaceutical company, Cortecs International, today announced that its Phase I trial of its Macrulin(TM) oral insulin formulation was presented during the Controlled Release Society 24th International Symposium on Controlled Release of Bioactive Materials held in Stockholm, 15-19th June. The report confirmed and expanded the preliminary data on the Macrulin(TM) Phase I trial announced last November. The challenge set by the trial was the avoidance of intestinal digestion of Macrulin(TM) and its passage through the bloodstream to the liver. The trial included six healthy subjects who received Macrulin(TM) or oral placebo via a tube passing through the mouth into the upper intestine. Each subject was studied twice, once receiving placebo and once receiving a commercially viable dose of Macrulin(TM) in randomised order. The subjects were simultaneously administered a glucose solution intravenously. Blood samples were collected before starting the experiment and at timed intervals afterwards and assayed for insulin and reduction of C-peptide and glucose levels. The results showed that after administration of Macrulin(TM) the subjects’ C-peptide response reduced, insulin levels in the blood increased and there was an increase in the disappearance rate of blood glucose thus successfully meeting the trial challenge. The C-peptide, which is a measure of the body’s own insulin production was reduced by more than 40% over a period of four hours. Commenting Dr. Michael Flynn, President of Cortecs International said the company is planning a Phase IIa Macrulin trial in diabetics using encapsulated Macrulin. E-mail this page to a friend or colleague! To print, use this version