
Bionovo's Independent Data Safety Monitoring Board Recommends
Continuation of Phase 3 Study for Menerba™
2012-03-28 11:59 ET - News Release
EMERYVILLE, Calif., March 28, 2012 /PRNewswire/ -- Bionovo, Inc.
(OTCQB: BNVI), a pharmaceutical company focused on the discovery
and development of safe and effective treatments for women's health
and cancer, announced today that the Company's independent Data
Safety Monitoring Board (DSMB) recommended that the Phase 3 trial
of Menerba (MF101) could continue as designed after an initial
review of its clinical safety and tolerability data. Menerba is
Bionovo's oral botanical drug candidate designed for the safe and
effective treatment of vasomotor symptoms (hot flashes) associated
with menopause.
The DSMB evaluated unblinded safety and dose tolerability data
after 66 participants were randomized and on study medication for
at least 30 days. After an independent review of the data, the DSMB
issued their positive recommendation to continue the trial as
originally designed and no concerning safety signals were
identified.
"I am very encouraged by the positive recommendation from our
independent DSMB. This assurance that Menerba™ continues to be a
safe, well-tolerated, non-estrogen alternative therapy for the
treatment of menopausal hot flashes is consistent with the
promising results of our early clinical trial data and extensive
pre-clinical toxicity studies. We are very eager to continue to
develop a safe and effective treatment for post-menopausal hot
flashes, a drug that can be the leading seller in the well
established multibillion dollar market," said Mary Tagliaferri,
M.D., Bionovo's President and Chief Medical Officer.
The MF101-004 Phase 3 pivotal study dosed its first patient on
November 16, 2011. To date, a total of 280 postmenopausal women
have been randomized to the trial. Recruitment to the Phase 3 trial
was voluntarily halted on March 9, 2012 as Bionovo does not have
adequate funding to further advance the registration trial. Bionovo
will need to secure additional financing to complete either a
smaller Phase 2B trial with the current cohort of 280 randomized
participants or to complete the planned Phase 3 study.
The purpose of the study is to evaluate the safety and efficacy of
two doses of Menerba™ (MF101) among a cohort of postmenopausal
women for the treatment of menopausal hot flashes. (Logo:
http://photos.prnewswire.com/prnh/20111110/SF04662LOGO)
Participants are randomized to Menerba™ 5g/day, Menerba™ 10g/day or
placebo and treated for 12 weeks. Efficacy will be measured by the
reduction of moderate to severe hot flashes from baseline to 12
weeks of treatment Dr. Wulf Utian, Executive Director Emeritus and
Honorary Founding President of the North America Menopause Society
and Professor Emeritus at Case Western Reserve University is
serving as the Principal Investigator for this study.
About Menerba
Menerba is an oral drug candidate designed for the safe, effective
treatment of vasomotor symptoms (hot flashes) associated with
menopause, which is manufactured from botanical sources. Menerba™
is an estrogen receptor beta (ER-b) selective drug, developed as an
alternative to the products currently on the market which 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 activation of estrogen receptor alpha (ER-a) and
that activation of estrogen receptor beta (ER-b) blocks the growth
promoting effects on breast cancer cells. The active ingredients in
Menerba™ are derived from botanicals with centuries of recorded
safe, effective use in traditional Chinese medicine (TCM). Bionovo
recognizes the opportunity to commercialize a product that would be
as effective as hormone therapy, without the health risks. Menerba™
has completed a Phase 2 trial with positive results for efficacy
and has been evaluated by an independent Data and Safety Monitoring
Board and passed through a standard two-round examination for
safety. Menerba™ also has been shown in animal studies to prevent
the proliferation of breast cancer and to have a beneficial effect
on osteoporosis, though this has not yet been studied in
humans.
Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery
and development of safe and effective treatments for women's health
and cancer, markets with significant unmet needs and billions in
potential annual revenue. The Company applies its expertise in the
biology of menopause and cancer to design new drugs derived from
botanical sources which have novel mechanisms of action. Based on
the results of early and mid-stage clinical trials, Bionovo
believes they have discovered new classes of drug candidates within
their rich pipeline with the potential to be leaders in their
markets. Bionovo is headquartered in Emeryville, California. For
more information about Bionovo and its programs, visit:
http://www.bionovo.com.
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 http://www.sec.gov. 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
SOURCE Bionovo, Inc.