Cortecs International Ltd. plans to go ahead with Phase II trials oforally delivered calcitonin for post-menopausal osteoporosis andPaget's disease of the bone. The trial will involve 36 patients at aLondon teaching hospital.Leon Gauci, executive vice president of U.S. operations for the U.K.company, told BioWorld the trial should extend through the end of theyear, primarily because of the difficulty expected in enrolling patientswho meet strict criteria.The post-menopausal trial will include 24 patients, and the Paget'sdisease trial will include 12. They will involve administration of oralcalcitonin and placebo. "The patients are going to be treated for onemonth," Gauci said. "The important parameters in this time period arethe bone markers and pain."The action of calcitonin in Phase I trials was monitored by measuringthe excretion of deoxypyridinoline (DPD), a collagen breakdownproduct produced when bone is destroyed. Calcitonin acts by inhibitingthe action of osteoclasts, which are cells that break down bone.Cortecs reported positive results in the Phase I tests using single dosesdown to 400 units of oral calcitonin in healthy volunteers, whichstrongly suggests, Gauci said, the likelihood that positive results will beseen in patients, and in treatments involving multiple doses.He said the single dose of 400 units delivered orally gave the samedegree of suppression that was seen when 100 units were deliveredsubcutaneously. _ Jim Shrine
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