Bionovo Announces Publication Describing Menerba's Effect on Neural Pathways Related to Temperature Regulation
Results are Published In PLoS One
EMERYVILLE, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Bionovo,
Inc. (NASDAQ:BNVI) today announced results from
studies in neurons of its drug candidate Menerba for the treatment
of menopausal hot flashes. The study, published in the Public
Library of Science (PLoS) One, describes a novel model for
thermoregulatory control with neurons that are differentiated from
stem cells, and express native estrogen receptors. Menerba, an
estrogen receptor beta selective modulator, was shown to regulate
calcium influx, which is related to temperature regulation.
"Menopausal hot flashes occur in approximately 80% of menopausal
women. While estrogens are very effective in the treatment of
menopausal hot flashes, they have been associated with many serious
health risks, such as breast and uterine cancer. Recognizing this,
we have been trying to develop safer ways of treating hot flashes
and other menopausal symptoms. But to do that, we need to have
reliable models for thermoregulatory control - something that we
have not had previously. Our study showed that neurons derived from
embryonic stem cells are a valuable screening model to identify new
treatments for hot flash management because they reliably show a
drug candidate's ability to act directly at the neural level. We
also found that Menerba, an estrogen receptor beta selective drug
candidate being developed by Bionovo, does indeed regulate the
activity of the neurons, identifying this receptor subtype as an
important target for new drugs for treating hot flashes," said Dr.
Dale Leitman, from the Department of Nutritional Science and
Toxicology, University of California, Berkeley, who is the
Principal Investigator of the study.
"This is a novel and valuable model for investigating
thermoregulation," said Isaac Cohen, Bionovo's Chairman and Chief
Executive Officer. "In a Phase 2 clinical trial, Menerba, our
selective estrogen receptor beta modulator, showed that it was
effective in the treatment of hot flashes, but unlike estrogen, it
did not adversely affect the uterus. This study provides an
explanation on how Menerba is able to control hot flashes. With the
clinical data already developed, and the data from Dr. Leitman's
research, we are much more confident in Menerba as it enters
pivotal Phase 3 trials."
The publication is entitled "Estrogen Receptor B-Selective
Agonists Stimulate Calcium Oscillations in Human and Mouse
Embryonic Stem Cell-Derived Neurons" and can be found on the PLoS
One website and at http://www.bionovo.com/investors/publications.
Menerba is an oral, botanically-derived drug candidate designed
for the safe, effective treatment of vasomotor symptoms (hot
flashes) associated with menopause. Menerba is an estrogen receptor
beta (ER-B) selective drug, developed as a safer alternative to the
products currently on the market, which have been shown to increase
the risk for breast and uterine cancers. Clinical tests conducted
thus far, following the specific guidance of the FDA, have
indicated that Menerba is effective and safe.
About Bionovo, Inc.
Bionovo 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 and is
traded on the NASDAQ Capital Market under the symbol, "BNVI". 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.
CONTACT: CONTACT: Investors, Joe Diaz, Robert Blum or Joe
Lytham Partners, LLC, +1-602-889-9700, firstname.lastname@example.org, For Bionovo,
Inc.; or Media, Tom Chesterman of Bionovo, Inc., +1-510-420-4189,
Web Site: http://www.bionovo.com/
Posted: August 2010