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Unigene Initiates Phase I/II Clinical Study for Oral Calcitonin
Unigene Laboratories, Inc. (OTCBB: UGNE) has initiated a Phase I/II clinical study in the U.S. 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.
The tablets being tested in the study utilize the same improved solid dosage form of Unigene's Enteripep(R) oral delivery technology used in Unigene's prior oral calcitonin study that was completed last fall. In that study, the new dosage form achieved a biological response in 100% of the study subjects.
"We are very pleased with the performance to date of these improved tablets," reported Dr. Ronald S. Levy, Executive Vice President of Unigene. "They have performed well in both animal and human studies and have demonstrated all of the properties required for a pharmaceutically-acceptable dosage form, including stability, bioavailability and dosing consistency. We have already shown that they can effectively deliver other peptides in repeated animal testing. 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."