US- and Swiss-based biopharmaceutical company Unigene Laboratories has initiated a phase I/II clinical study in the USA with its proprietary formulation of oral calcitonin for the treatment of osteoporosis.
Twenty-four healthy postmenopausal women have been enrolled in the study, which will measure the effect of the drug on a well-established biochemical marker.
The dosing is scheduled to be completed by the end of February.
Executive vice-president Dr Ronald Levy said the tablets being tested in the study utilised the same improved solid dosage form of Unigene’s Enteripep® oral delivery technology, used in Unigene’s prior oral calcitonin study completed last autumn.
In that study, the new dosage form achieved a biological response in 100% of the study subjects.