the trial is now open for enrollment at 17 clinical sites in the
U.S., and is expected to enroll 80 patients in the trial. There are
currently over 160,000 women living with metastatic breast cancer in
-- The Company presented an analysis of the metabolism of one of the
active chemical ingredients of MF101, the Company's drug candidate
for the treatment of menopausal hot flashes. The presentation, to
the American Society for Pharmacology and Experimental Therapeutics,
Drug Metabolism and Disposition, adds to the growing body of data
supporting MF101's mechanism of action, safety and potential
potency, as well as furthering the intellectual property protection
for the Company.
-- Also on MF101, the Company released data from its previous Phase 2
study that showed MF101's superior efficacy with respect to "night
sweats" or "night awakenings due to hot flashes" -- a particularly
debilitating form of hot flash for which many women seek medical
treatment and improved quality of life. This adds to the increasing
evidence of the possible efficacy of MF101 and the market
opportunity awaiting MF101 if and when it is approved by the FDA and
put on the market.
-- The Company is currently in discussions with the FDA on the specific
requirements for progression to Phase 3 pivotal trials of MF101. The
Company expects to have resolution, and to be in a position to
continue the clinical development and trials for MF101, by the end
of the year.
-- The Company presented a report to the North American Menopause
Society (NAMS), showing laboratory results of superior efficacy for
VG101, the Company's drug candidate for menopausal vagin
|SOURCE Bionovo, Inc.|
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