A peptide delivery system that would allow people with osteoporosis orPaget's Disease to take peptides orally instead of by injection orintranasally has completed Phase I clinical trials in England, CortecsInternational Ltd. has announced."Peptides are normally administered by injection two or three times aweek, either by the patients themselves or by their doctors." It's notmuch fun, and it's costly and inconvenient, especially since peoplewith osteoporosis are generally elderly, said Michael Flynn, presidentof the London-based company. "The advantage of the oral method isthat it's user-friendly."Cortecs' treatment, Macromol, uses a commercially viable dose of thepeptide salmon calcitonin. In order to overcome the difficulty oftransporting peptide molecules through cell membranes, Macromol isformulated as a water-in-oil emulsion. "By making the moleculessoluble in lipids we created a complex which is fat soluble, making iteasier for the molecules to cross the membrane, get into the cell, and beabsorbed from the lumen," Flynn said.Calcitonin was administered subcutaneously, intranasally, and orally tohealthy subjects in the trials. Reduction in deoxypyridinoline (DPD)excretion was used as a marker for suppression of the activity ofosteoclasts, cells that break down bone and cause osteoporosis andother diseases. According to Flynn, the trial showed a substantial andstatistically significant result for the oral dose similar to the responsewhen given subcutaneously or intranasally. The excretion of DPD inthe urine could be suppressed with an oral dose of 400 units and asubcutaneous dose of 100 units.Flynn said Cortecs hopes to begin Phase II trials this summer ifBritain's Medicines Control Agency gives its approval.Cortecs (NASDAQ:DLVRY/ASX:CRI) has also signed a furthertesting agreement with Boehringer Mannheim-Diagnostics, a divisionof Corange, regarding Cortecs' Helisal Rapid Blood, a productdeveloped jointly by Cortecs' Australian subsidiary. The productallows a physician to diagnose a Helicobacter pylori infection, oftenassociated with peptic ulcers, with a single drop of blood in his office.The product will be marketed in the U.K. this summer.Boehringer, which is located in Waldhof, Germany, has agreed tofield-test the product in some 500 patients with gastric ulcer symptomsin Germany against current serum laboratory tests and biopsy. InMarch the two companies made a similar agreement regarding Helisalserum, a lab-based test developed by Cortecs.

-- Philippa Maister

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