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, 2008. The tablets being tested in the study utilize the same improved solid dosage form of Unigene’s Enteripep oral delivery technology used in Unigene’s prior oral calcitonin study that was completed in fall of 2007. In that study, the new dosage form achieved a biological response in 100% of the study subjects.
Ronald Levy, executive vice president of Unigene, said: “The refinements that we have incorporated have clearly enhanced our original formulation technology and at the same time have enabled us to establish an even stronger intellectual property portfolio.”