Aa
Treatment/New Research
I have Invasive Lobular Carcinoma and Metastatic Carcinoma. I will be doing chemo, radiation and estrogen blockers. The estrogen and progestron and Hr2 are all positive.
1. Are there any new methods of treatment or drugs that show promise for my cancer.
1. Are there any new methods of treatment or drugs that show promise for my cancer.
Hi,
I'm not sure if this new drug is for one specific HER2neu category, negative or positive or if it's effective on both equally for treatment of mets.. but here goes:
Bezielle Phase 1B gets + Results for BC Mets
Date: August 05, 2009, 14:12:15 (about 1 hour ago)
FYI – Phase 1b mostly is done to determine dosing (including maximum
tolerated dose), side effects, absorption, distribution, metabolism, and
excretion of the drug. However, in oncology, it’s also possible to gain some
response/efficacy data because unlike other drugs (where Phase 1 is done in healthy
patients), these are done in patients with the disease. Jeannie P.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for
Metastatic Breast Cancer
EMERYVILLE, Calif., August 4 /PRNewswire-FirstCall/ -- Bionovo, Inc.
(Nasdaq: _BNVI_
(http://studio-5.financialcontent.com/prnews?Page=Quote&Ticker=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 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 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 (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/) _http://www.bionovo.com/_
(http://www.bionovo.com/) .
It never hurts to ask questions, so ask your Dr. if this is an option for you.
Best wishes :)
I'm not sure if this new drug is for one specific HER2neu category, negative or positive or if it's effective on both equally for treatment of mets.. but here goes:
Bezielle Phase 1B gets + Results for BC Mets
Date: August 05, 2009, 14:12:15 (about 1 hour ago)
FYI – Phase 1b mostly is done to determine dosing (including maximum
tolerated dose), side effects, absorption, distribution, metabolism, and
excretion of the drug. However, in oncology, it’s also possible to gain some
response/efficacy data because unlike other drugs (where Phase 1 is done in healthy
patients), these are done in patients with the disease. Jeannie P.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for
Metastatic Breast Cancer
EMERYVILLE, Calif., August 4 /PRNewswire-FirstCall/ -- Bionovo, Inc.
(Nasdaq: _BNVI_
(http://studio-5.financialcontent.com/prnews?Page=Quote&Ticker=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 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 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 (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/) _http://www.bionovo.com/_
(http://www.bionovo.com/) .
It never hurts to ask questions, so ask your Dr. if this is an option for you.
Best wishes :)
I believe we have responded to a similar post of yours previously regarding treatment. You have been prescribed the standard treatment method for your situation; if there are newer treatment options your Oncologist would be the best source of this information. Treatment plans are formulated specifically for each patient based on the complete history and Pathology of their cancer. Regards ....
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