Bionovo, Inc.'s
(Nasdaq: BNVI) lead drug candidate, MF101, showed positive Phase 2 results
for the treatment of hot flashes associated with menopause. Two hundred and
seventeen women were enrolled in the company's double-blind, placebo-
controlled, randomized Phase 2 trial. Postmenopausal women with 50 or more
moderate to severe hot flashes per week were randomized to one of three
treatment groups receiving MF101 (5 grams/day), MF101 (10 grams/day), or
placebo for twelve weeks. The trial was led by Dr. Deborah Grady at the
University of California, San Francisco and was conducted at six medical
centers in the United States: University of California, San Francisco,
University of Minnesota, Minneapolis, University of Pittsburgh, University
of Tennessee, Memphis, University of Alabama, Birmingham and the San Diego
Medical Center for Clinical Research.
Bionovo's primary objectives in the Phase 2 clinical trial were to
assess the safety, tolerability and the potential efficacy of two doses of
MF101 to reduce the frequency and severity of hot flashes. Both doses of
MF101 were more effective than placebo at reducing the frequency and
severity of hot flashes from the start of the trial until the end of the
treatment period 12 weeks later. In a paired t-test, comparing the number
of hot flashes per day after 12 weeks of treatment, MF101 5 gm was better
than placebo at 12 weeks but did not reach statistical significance
(p=0.06). The higher dose was statistically superior to placebo with a p
value of 0.05 and both doses combined were superior to placebo with a p
value of 0.04. MF101 showed a trend for improvement in severity of hot
flashes compared to placebo with the higher dose showing greater
improvement (p=0.1) than the lower dose (p=0.12) and with both doses
combined superior to placebo (p=0.08). There was a dose response trend
suggesting that the higher dose of MF101 was more effective at reducing
both frequency and severity of hot flashes than the lower dose.
In secondary analyses, the percent of women reporting greater than 50%
reduction in all hot flashes was statistically significantly higher in the
MF101 high dose group compared to placebo (p=0.03) and in both doses of
MF101 combined compared to placebo (p=0.05).
MF101 is a novel estrogen receptor beta agonist that is expected not to
stimulate the endometrium or breast tissue. Safety analyses showed no cases
of endometrial hyperplasia or uterine cancer during the trial and there
were no differences in incidence of vaginal bleeding between the placebo
group and the two cohorts treated with MF101. The only side effect that
increased with MF101 treatment was loose stool/diarrhea (12% in each of the
drug arms vs. 3% in placebo arm). Constipation was improved with MF101
therapy. These observations are consistent with the presence of soluble
fiber in the drug extract, which future optimization of the manufacturing
process will significantly reduce. Adherence to the study medication was
high with 91% of the participants compliant with treatment after 12 weeks
of therapy.
"I am very encouraged and pleased by the findings of this clinical
trial," said Deborah Grady, M.D., Associate Dean for Clinical and
Translational Science, Professor of Medicine and Director of the University
of California, San Francisco (UCSF) Women's Health Clinical Research
Center. "The combination of a trend to better efficacy with a higher dose
of MF101 and a very strong safety profile of a drug that was very well
tolerated by menopausal women is exciting news. These early positive
clinical results are not only encouraging for discovering a safer therapy
for hot flashes but also support the role of estrogen receptor beta as a
novel target for treating menopausal symptoms."
"Recent clinical trials, such as the HERS and the WHI, elucidated
important safety concerns of postmenopausal hormone therapy and resulted in
significantly fewer women using these products," said Isaac Cohen, CEO of
Bionovo. "For this reason, it is important for us to find safer
alternatives for treating menopausal symptoms. The favorable dose response
trend signals that MF101 may become a clear alternative to traditional
postmenopausal hormone therapy for relief of vasomotor symptoms. We are
excited by the prospect of moving forward with the development of a product
that could potentially have such broad reach and positively affect the
quality of life for millions of women and their loved ones. This first
Phase 2 trial conducted by Bionovo serves as a proof of our drug
development strategy and we look forward to advancing MF101 into
registration trials."
About MF101
MF101 is an estrogen receptor (ER) beta selective drug developed as an
alternative to postmenopausal hormone products currently on the market,
which are both ER beta and ER alpha agonists that have been shown to
increase the risk for breast and uterine cancers. It has been shown that
the increased risk of breast and uterine cancers is associated with ER
alpha activation and that ER beta blocks the growth promoting effects on
breast cancer cells. Bionovo recognized the opportunity to commercialize a
product that would be equally effective, with an improved safety profile
compared to traditional hormone therapy. The clinical trial results have
been evaluated by an independent Data and Safety Monitoring Board and the
drug candidate has passed through a standard two-phase examination for
safety.
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
two drugs in clinical testing. MF101 has completed Phase 2 for quality of
life conditions associated with menopause, and BZL101 is in Phase 1/2 for
the treatment of advanced breast cancer. The company has an additional
pipeline of drugs in development for breast cancer, pancreatic cancer and
other menopausal symptoms. The company is developing its products in close
collaboration with leading U.S. academic research centers including:
University of California, San Francisco, University of California, Davis,
and the University of Colorado Health Sciences Center. For further
information please visit: bionovo.
Forward-Looking Statements
This release contains certain forward-looking statements relating to
the business of Bionovo, Inc. that can be identified by the use of
forward-looking terminology such as "believes," "expects," or similar
expressions. Such forward-looking statements involve known and unknown
risks and uncertainties, including uncertainties relating to product
development, efficacy and safety, regulatory actions or delays, the ability
to obtain or maintain patent or other proprietary intellectual property
protection, market acceptance, physician acceptance, third party
reimbursement, future capital requirements, competition in general and
other factors that may cause actual results to be materially different from
those described herein as anticipated, believed, estimated or expected.
Certain of these risks and uncertainties are or will be described in
greater detail in our filings with the Securities and Exchange Commission,
which are available at sec. Bionovo, Inc. is under no
obligation (and expressly disclaims any such obligation) to update or alter
its forward-looking statements whether as a result of new information,
future events or otherwise.
Bionovo, Inc.
bionovo
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