Bionovo, Inc.
(OTC Bulletin Board: BNVI) provided an update on its Phase 2 clinical trial
of MF101, a novel, oral treatment for hot flashes and other symptoms of
menopause. The Company has fully enrolled its FDA-approved trial with 184
women volunteers. Dr. Deborah Grady at the University of California, San
Francisco is serving as the Principal Investigator and the multi-center
trial is being conducted at six clinical sites across the country. The
trial will evaluate the efficacy of MF101 on actual and perceived relief
from menopausal symptoms. The women enrolled in the trial are aged 40-60
and experiencing greater than 7 moderate-to-severe hot flashes each day.
MF101 is an estrogen receptor beta (ER-beta) selective drug developed
as an alternative to those products currently on the market that have been
shown to increase the risk for breast and uterine cancers. Bionovo
recognized the opportunity to commercialize a product that would be equally
effective, with an improved safety profile to hormone therapy, and began
the clinical development of MF101. The drug candidate has been evaluated by
an independent Data and Safety Monitoring Board and has passed through a
standard two-round examination for safety. The Phase 2 study is expected to
run for an additional four months with results anticipated in early April
2007.
"For too long women had to face the choice between quality of life and
their long-term health," said Isaac Cohen, President and CEO, Bionovo. "The
market for menopausal products is enormous and growing, and we believe
there is great opportunity for a product that offers both efficacy and
safety."
The Phase 2 trial is a double-blind, randomized, placebo-controlled
trial. Women volunteers were randomized to groups of 60 receiving 2 doses
of MF101 or placebo. The trial is being conducted at the following sites:
University of California, San Francisco, University of Pittsburgh,
University of Minnesota, University of Tennessee, University of Alabama and
the San Diego Medical Center for Clinical Research.
About MF101
MF101, an ER-beta selective agonist, is designed for the treatment of
vasomotor symptoms such as hot flashes and night sweats in postmenopausal
women. In animal studies, MF101 has been shown to prevent tumor formation
in the breast and uterus, suggesting that Bionovo's lead drug will not
increase the risk of either breast or uterine cancer. In Phase 1 clinical
testing of MF101, the drug was found to be safe, well tolerated and taken
with high compliance. A multi-center, Phase 2, double-blind,
placebo-controlled, randomized clinical trial of MF101 has completed full
enrollment of 180 patients.
About Bionovo, Inc.
Bionovo is a drug development company focusing on the discovery of
novel pharmaceutical agents for cancer and women's health. The company has
one drug in Phase 2 clinical testing to treat conditions associated with
menopause and a second drug, BZL101, for breast cancer that will enter
Phase 2 clinical testing later this year. The company is developing its
products in close collaboration with leading U.S. academic research
centers, including the University of California, San Francisco, University
of Colorado Health Sciences Center, University of California, Berkeley, and
the University of Texas, Southwestern. For further information please
visit: bionovo/.
Bionovo, Inc
bionovo/
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