Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for Metastatic Breast Cancer
EMERYVILLE, Calif., August 4 /PRNewswire-FirstCall/ -- Bionovo,
Inc. (NASDAQ:BNVI) today announced positive results
from the Phase 1B clinical trial of Bezielle (formerly BZL101),
their lead drug candidate for advanced breast cancer. In the trial,
Bezielle showed an excellent safety and tolerability profile, and
also showed promising indications of efficacy in a
difficult-to-treat population.
The Phase 1B clinical trial was conducted at eight US clinical
sites under the directorship of Dr. Charles Shapiro, Professor of
Medicine and Director of Breast Oncology at Ohio State University.
The primary objective of the study was to identify the maximum
tolerated dose of Bezielle and to determine the safety, feasibility
and preliminary efficacy of the Company's novel, oral, anticancer
therapy. A total of twenty-seven women with metastatic breast
cancer were enrolled to the Phase 1B trial.
To date, 48 women with advanced breast cancer have been
successfully treated with Bezielle in two early clinical trials. In
a previous Phase 1A study, Bezielle demonstrated very limited
toxicity with a favorable tolerability profile and encouraging
clinical activity among a cohort of patients with metastatic breast
cancer who had been heavily pretreated with anticancer therapies.
Results from this second Phase 1B study provide further support
that Bezielle is safe and well-tolerated, with early signs of
clinical efficacy.
Safety Analysis
In comparison to other oral cytotoxic agents, Bezielle was
extremely safe and well tolerated. No drug-related deaths or
serious adverse events occurred during the study, and 94% of all
drug-related adverse events were classified as grade 1 and 2 side
effects per the National Cancer Institute Common Terminology
Criteria for Adverse Events. The most common adverse events
associated with Bezielle were grade 1 and 2 gastrointestinal side
effects, accounting for 56% of all drug-related adverse
events.
Efficacy Analysis
Sixteen of the twenty-seven participants in the Phase 1B
clinical trial were evaluable according to the Response Evaluation
Criteria in Solid Tumors (RECIST). Of these sixteen evaluable
women, five (31%) were stable on Bezielle for greater than 90 days
and two (13%) were stable on Bezielle for greater than 180 days.
Three patients (19%) on Bezielle had objective tumor regression, as
evaluated by an independent radiology review.
Four patients discontinued from the study with stable disease,
and of these four patients, one patient had objective tumor
regression during 449 days of Bezielle treatment and continues to
be stable off of study medication for a total of 600 days. A second
patient who discontinued Bezielle treatment with stable disease
continues to be stable for 832 days and has not started any new
anticancer treatment. A third patient who discontinued with stable
disease was stable for 591 days before evidence of progression.
Further analyses on overall survival and progression-free survival
will be performed.
Dose Escalation and Compliance
Overall compliance with study medication was excellent with 90%
of prescribed doses taken. A maximum tolerated dose, as defined in
study protocol, was never established despite dose escalation
reaching a dose that was four times (40g/day) the previously
evaluated Phase 1A dose.
"We are eager to advance Bezielle to Phase 2 clinical testing as
the drug continues to have an improved safety profile over
currently available chemotherapeutic agents, and shows encouraging
clinical activity in a cohort of women who have been heavily
pretreated for metastatic breast cancer," said Dr. Mary
Tagliaferri, President and Chief Medical Officer, Bionovo.
"We are encouraged by the results of the Company's second Phase
1 trial in women with advanced breast cancer," said Isaac Cohen,
Chairman and CEO of Bionovo. "Despite improvements in currently
available breast cancer therapies, the five-year survival rate of
women who develop metastatic disease is still only 27%. Many of
these therapies cause women with advanced breast cancer additional
discomfort through severe side effects resulting in a poor quality
of life at the end of life. There are currently over 160,000 women
in the United States living with advanced breast cancer who are
eagerly awaiting an oral anticancer drug with minimal side effects
that can extend life without profoundly diminishing their quality
of life. We are aiming to improve the extract formulation so we can
further improve on the gastrointestinal symptoms associated with
Bezielle treatment. We believe Bezielle may be an important new
anticancer agent because its biological selectivity allows it to
kill cancer cells without affecting normal cells. This also leads
to a dramatically lower side effect profile."
Bezielle
Bezielle is an oral drug designed for the treatment of advanced
breast cancer with a novel mechanism of action. Bezielle targets
diseased cells while leaving normal cells healthy and intact.
Normal cells depend primarily on the citric acid cycle (>85%)
and very little on glycolysis (<7%) for energy production.
Cancer cells depend largely on glycolysis (>85%) for energy
production. Bezielle induces greater production of reactive oxygen
species in cancer cells. This results in high levels of DNA damage
and the hyperactivation of PARP. The resulting depletion of NAD and
ATP (PARP substrates), results in the inhibition of glycolysis,
energetic collapse, and programmed necrosis.
There are currently no effective therapeutic cures for advanced
breast cancer and treatment is primarily aimed at palliation of
symptoms as well as improving overall survival. Over 192,000 women
in the United States are diagnosed with breast cancer each year and
breast cancer is the second leading cause of cancer death in women.
Although survival after breast cancer treatment is improving, there
are still over 40,000 deaths per year due to the disease in the
Unites States alone.
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: Tom Chesterman, Bionovo, Inc., +1-510-601-2000,
investor@bionovo.com
Web Site: http://www.bionovo.com/
Posted: August 2009
