Cortecs' Oral Calcitonin Cuts Bone Breakdown By 50%

Cortecs International has reported positive results in the first Phase II clinical trial of its oral salmon calcitonin formulation. The study was carried out in Europe. Salmon calcitonin is normally administered by injection or intranasally, and sales of these forms are estimated at around $400 million a year.

The double-blind trial evaluated the effect of Cortecs' oral formulation of salmon calcitonin on inhibiting the breakdown of bone. In the trial, 12 patients received oral sCT 400IU daily for six months and 12 patients received placebo. Serial early morning urine samples were taken before daily treatment. The main response criterion was changes in urinary excretion of the bone resorption marker by the CrossLaps assay, developed by Osteometer, which has recently been approved by the US Food and Drug Administration.

These results follow the positive preliminary results from this Phase II trial, which were announced in November 1995, in which patients treated with oral calcitonin showed a significant fall in the rate of bone breakdown during the first 12 hours after each dose (Marketletter November 20, 1995).