Dec 11 2009
Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com)
announced that an independent Data Monitoring Committee (DMC) has
recommended that Novartis and its partner Nordic Bioscience proceed as
planned with their ongoing oral calcitonin Phase III studies for
osteoporosis and osteoarthritis.
Its recommendation is based on the committee’s recently completed
“futility” analysis of the data obtained from all patients enrolled for
at least twelve months in these studies. That analysis included an
assessment of both safety and efficacy parameters. It is the committee’s
opinion that there are no major or unexpected safety concerns and it
unanimously recommends to proceed with the studies to evaluate the
efficacy and safety profile of oral calcitonin as planned.
“The report of the DMC is an important benchmark in the conduct of these
trials and it provides the first preliminary indication of the drug’s
performance,” commented Dr. Ronald S. Levy, Executive Vice President of
Unigene Laboratories, Inc. “Unigene has a vested interest in the success
of these studies both from a milestone and a royalty perspective, and we
are encouraged by this committee’s recommendation.”
http://www.unigene.com/
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