bionovo
, m. d. , bionovo' s president and chief medical officer .
bionovo announced that the us patent and trademark office has issued a patent covering a method of using bionovo' s proprietary drug candidate bezielle for the treatment of metastatic breast cancer. the patent issued is bionovo' s second issued patent, with over 70 other patent applications currently pending. bionovo' s us patent no. 7, 700, 136 covers a method of treating breast cancer using an extract of scutellaria barbata .
contact: company, tom chesterman of bionovo, inc. , + 1 - 510 - 601 - 2000, investor @ bionovo. com; or investor, joe diaz, robert blum, or joe dorame, all of lytham partners, llc, + 1 - 602 - 889 - 9700, bnvi @ lythampartners. com, for bionovo, inc .
a pharmacognosy colleague contacted me on friday morning with word that the botanical drug development company bionovo was closing its chemistry group .
bionovo chairman and ceo isaac cohen added that the results from the trial will be submitted to the food and drug administration for approval .
what is a sad story is all the money used for mary and issac salaries and expenses on the backs granst and bionovo common shareholders .
emeryville, ca - bionovo, inc. recently announced that the fda has reviewed the company' s manufacturing and control process descriptions (cmc), and has provided guidance on how bionovo can move forward with the development of menerba (formerly named mf101) for menopausal hot flashes .
bionovo entered into a two - year securities purchase agreement for up to $ 5 million with socius cg ii ltd. bionovo inc. (nasdaq: bnvi), emeryville, calif. business: endocrine / metabolic, cancer date announced: 1 / 3 / 12 ...
and is traded on the nasdaq capital market under the symbol ,
bnvi
. for more information about bionovo and its programs, visit :
bionovo, which has 97. 7 million shares of common stock outstanding, has lost more than $ 87 million since its inception 10 years ago. the company also said in an sec filing that it could be sued for breach of contract by socius cg ii ltd. , a bermuda unit of socius capital group llc, with which bionovo made a stock deal in january. socius could seek $ 250, 000, bionovo said .
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 urltoken .
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 .
bionovo, inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for womens 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 .
bionovo has been the rare superb example of a company that’s been trying to develop fda - approvable drugs based on chinese traditional medicine. led by isaac cohen, a ucsf guest scientist and doctoral of oriental medicine, and chief medical officer, mary tagliaferri, bionovo took a hard, science - based approach to
but even with the fda’s accelerated botanical drug guidelines, the financial sustainability of bionovo has only allowed it to get one drug as far as phase iii .
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 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 .
with a stock price as high as $ 29. 50 in april 2007, bionovo closed at $ 0. 09 / share on friday before the formal announcement. i hope that an entity with a similar mindset on botanical drugs picks up the intellectual property of bionovo and continues with the work they have pioneered .
natural product chemist salaries at bionovo can range from $ 77, 299 - $ 85, 202. this estimate is based upon 2 bionovo natural product chemist salary report (s) provided by employees or estimated based upon statistical methods. see all natural product chemist salaries to learn how this stacks up in the market .
bionovo, a drug discovery and development company, has reported promising data describing predictable estrogen regulatory elements that can be used to identify estrogenic drugs that are safer .
he also said that bionovo is at the forefront of future serm products which are far more specific and safe. it is a breakthrough for all future drugs that regulate the diverse effects of conditions affected by nuclear receptors and bionovo is positioned to explore and exploit these pathways for many serious diseases with its expanded scientific collaborations, he added .
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 urltoken .
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
in 2002, tagliaferri and cohen left buck to establish bionovo, where they began phase ii trials of bzl101 in april 2006, expanding their studies to 10 hospitals and breast cancer centers, including the university of chicago medical center, duke university medical center and the m. d. anderson cancer center in houston. bionovo expects the second phase of trials to conclude by early 2008 .
the study was conducted by investigators at the center for reproductive sciences in the department of obstetrics, gynecology and reproductive sciences at the university of california, san francisco in collaboration with scientists at bionovo .
mary tagliaferri, bionovo president and chief medical officer, said earlier toxicology data and the mechanism of action, showed that higher doses of menerba were safe and demonstrated a level of efficacy similar to hormone therapy .
bionovo retained cowen and co. to explore strategic options due to a lack of cash needed to meet its near term needs, including the completion of a phase iii trial with menerba to treat ...
bionovo has made a significant commitment to the field of pharmacognosy and ethnomedicine in trying to bring forward traditional remedies to approved botanical drugs. they invested in the hires of several excellent natural products chemists, including some of our own colleagues. and those folks that i’ve met from bionovo, especially isaac cohen, are delightful people dedicated to using crosscultural knowledge to improve human health. you couldn’t help but pull for them to be successful .
bionovo inc. , which last week laid off more than 90 percent of its workforce, said monday that it will net $ 740, 000 by selling 14. 2 million shares of its common stock and warrants .
bionovo inc. (nasdaq: bnvi), emeryville, calif. business: endocrine / metabolic, cancer hired: david boyle as svp and cfo, formerly svp and cfo of avi biopharma inc... .
bionovo said it will voluntarily delist its shares from nasdaq, effective feb. 17. the company said it would be unable to regain compliance with the $ 1 minimum bid price requirement for continued listing and plans ...
, o. m. d. , chairman and ceo of bionovo .
the discussion with the fda was also fruitful concerning future potential labeling of menerba. bionovo provided additional data to support our claim that menerba is not an estrogen and not a serm. the fda acknowledged that menerba is a selective estrogen receptor beta agonist. granted we continue to show no safety concerns after the phase 3 trials, menerba will provide a safer alternative to current hormone therapy .
tripathy also says that companies like bionovo have a tough time getting funding either from the private sector or from pharmaceutical companies :
in the absence of controlled clinical trials, people are skeptical and say' there' s no evidence this works,'
he says. bionovo, which expects to begin phase iii trials in 2009, hopes to upset this way of thinking. and, says tagliaferri, the company is studying about two dozen other chinese herbs with anticancer potential .
while announcing the layoff of some 45 employees friday — based on the size of its workforce that it disclosed in february — bionovo said cash compensation for management also will decrease until adequate financing can be lined up or the company is sold .
biotech company bionovo has begun a phase 3 clinical trial designed to assess the safety and efficacy of two doses of oral estrogen receptor beta (er - b) selective drug, menerba (mf101), used to treat menopausal hot flashes .
bionovo reduced headcount by over 90% to save cash. at feb. 27, the company had 52 full - time employees. the remaining management said it will cease operations if sufficient funds are not received or if the ...
bionovo has reported that the first patient has now been randomized and will begin dosing in the phase iii pivotal clinical trial evaluating the safety and efficacy of two doses of menerba (mf101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes .
isaac cohen, chairman and ceo of bionovo, said: the discovery of these selective estrogen regulatory elements strengthens our selective estrogen receptor modulator discovery engine. the advantage of the new array, of specific regulatory elements, is manifest in the pharmacological and toxicological insights gained .
an independent dsmb recommended continuation of the double - blind, placebo - controlled u. s. phase iii mf101 - 004 trial based on safety data from 66 patients who received menerba for > = 30 days. last month, bionovo halted enrollment in the trial ...
bionovo, which purports to use traditional chinese medicine in its drug development process, took its “hot flashes” drug menerba into phase iii. an advanced breast cancer drug has completed two phase i studies, and the company was hoping to take a topical treatment for vaginal atrophy into the clinic .
even more interesting to me was bionovo’s extract of scutellaria barbata (bzl101, bezielle). given the recent enthusiasm in searching for drugs that targeted the aerobic glycolysis phenotype of many cancers, bzl101 was exciting because it had these effects in cell culture and was formulated into an oral preparation with good bioavailability .
bionovo had $ 2. 5 million in cash and equivalents and another $ 500, 000 in short - term securities as of dec. 31, the company said in a securities and exchange commission filing. that figure had fallen to $ 311, 000 as of monday, it said in the filing .
the company in november moved production employees from aurora, colo. , to hayward, where last year it signed a 10 - year, non - cancelable operating lease with biomed realty trust. the lease calls for payments starting at $ 18, 750 and for bionovo to grow to 51, 472 square feet beginning in 2015 .
, o. m. d. , chairman and chief executive officer of bionovo .
menerba (mf101) has an enormous proven market and extraordinary market appeal due to its botanical origins and the safety and efficacy it demonstrated to date. we expect to have top - line data from this study in approximately 18 months .
bionovo inc. (pink: bnvi), emeryville, calif. business: endocrine / metabolic, cancer date announced: 2 / 8 / 12 type: private placement of convertible preferred stock and warrants to be raised: up to $ 25 million price prior: $ 0. 13 placement agent: cowen shares outstanding ...
we are pleased to announce that we are initiating the phase 1 tolerability clinical trial. we are confident that the trial will proceed quickly and successfully. we are diligently executing on all our milestones, clinical and non - clinical activities, in 2011 ,
commented dr. isaac cohen, chairman and chief executive officer of bionovo, inc .
/ prnewswire - firstcall / - - bionovo, inc. (nasdaq: bnvi), a pharmaceutical company focused on the discovery and development of innovative treatments for women' s health and cancer, today announced that it had received the minutes from the u. s. food and drug administration' s (fda) clinical guidance meeting that took place on
bionovo inc. (pink: bnvi), emeryville, calif. business: endocrine / metabolic, cancer date announced: 3 / 12 / 12 type: private placement of common stock and warrants to be raised: about $ 426, 951 shares: 14. 2 million price prior: $ 0. 09 shares outstanding prior: 60. 6 million ...
we have concluded three cmc discussions with the fda, and are moving to address the agency' s recommendations for further development of menerba. the recommendations with respect to the analytical characterization were made by the pre - marketing division of the agency, in order to ensure continuous drug consistency. there are some areas of the drug development process requiring further discussion on how to best implement the agency' s guidance for industry for botanical drug products. bionovo will be moving with all possible diligence to reach agreement on these areas with the fda. we will start manufacturing the clinical material using the commercial process immediately. during these discussions no concerns were expressed about either the safety nor the efficacy of menerba ,
said dr. isaac cohen, bionovo' s chairman and ceo .
emeryville, calif. , march 2 / prnewswire - firstcall / - - bionovo, inc. (nasdaq: bnvi) today announced the online publication of a peer - reviewed article in the journal, menopause, reporting menerba (tm) (formerly mf101) is well tolerated, safe and effective for the treatment of vasomotor symptoms (hot flashes and night sweats) associated with menopause .
( i should make the disclaimer here that my wife, a former duke university breast oncologist, enrolled patients in a phase i trial of bzl101 and was co - author of a 2008 asco abstract on the results. however, she received no personal compensation for this work and we have never owned stock in bionovo. we just admire what they are trying to do in women’s health. )
emeryville, calif.  november 10, 2010  bionovo, inc. (nasdaq: bnvi), a pharmaceutical company focused on the discovery and development of safe and effective treatments for womens health and cancer, today announced that the u. s. food and drug administration (fda) has approved the companys total clinical development plan for menerba, the companys drug candidate for menopausal hot flashes .
the positive results of menerba to date are very encouraging. our discussions with the fda clinical staff, our scientific advisory board, our clinical investigators, and our reception at the many scientific conferences at which we have presented - - all have served to strengthen our confidence that bionovo' s menerba will be able to provide menopausal women with a safe and efficacious alternative to the existing drugs on the market. this is particularly important because all current drugs for hot flashes carry six black box warnings by the fda for potentially serious adverse events. as a next step, we have plans to meet with the clinical review team at the fda to reach an agreement on the clinical path forward ,
said dr. mary tagliaferri, m. d. , bionovo' s president and chief medical officer .
bionovo, inc. (nasdaq: bnvi), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women' s health and cancer, today announced that enrollment has started for the phase 1 clinical trial testing the safety of two doses of menerba in postmenopausal women for the treatment of menopausal hot flushes (study # mf101 - 008), also known as
menopausal hot flashes .
jim stapleton, mba, joined the company on may 2, 2016 as the cfo, and brings over 25 years of public company cfo experience across a wide range of industries. specific to mt. tam, mr. stapleton was the cfo of bionovo, a clinical state drug discovery and development company from 2005 through 2007, and was the cfo of a biotech device company, biotech solutions and is responsible for raising more than $ 100m from institutional investors while serving as cfo for both companies .
some of their early work was with a molecular endocrinology physician - scientist dale leitman, then at ucsf. leitman has a solid track record in the transcriptional regulation of estrogen receptor - beta (erβ), particularly by natural products such as soy isoflavones. leitman led the group that reported in 2007 that a 22 - herb extract, bionovo’s mf101 (menerba), had selective erβ agonist activity with the potential for treating menopausal symptoms without increased risk of breast cancer. this extract advanced to phase iii trials last october .
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 urltoken. 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 .
emeryville, calif. , jan. 14 / prnewswire - firstcall / - - bionovo, inc. announced today the publication of their results from its phase 1b clinical trial of bezielle (bzl101) for metastatic breast cancer. the results of the study are available online in breast cancer research and treatment and demonstrate that bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. preliminary results from this study were released previously by the company .
emeryville, ca / prnewswire - firstcall / - - bionovo, inc. (nasdaq: bnvi) announced today the publication of their results from its phase 1b clinical trial of bezielle (bzl101) for metastatic breast cancer. the results of the study are available online in breast cancer research and treatment and demonstrate that bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. preliminary results from this study were released previously by the company .
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 urltoken. 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 .
this phase 1 clinical trial is testing two doses of menerba that are higher than the already proven efficacious dose evaluated in our phase 2 trial, which showed efficacy equivalent to recently approved low dose menopausal hormone therapy (mht). we are escalating the dose of menerba to reach similar efficacy as the high doses of mht. our goal is to define a full therapeutic window that matches or improves on currently approved mht drugs ,
said mary tagliaferri, m. d. , bionovo' s president and chief medical officer .
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 .
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 .
emeryville, calif. , jan. 14 / prnewswire - firstcall / - - bionovo, inc. (nasdaq: bnvi) announced today the publication of their results from its phase 1b clinical trial of bezielle (bzl101) for metastatic breast cancer. the results of the study are available online in breast cancer research and treatment and demonstrate that bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer. preliminary results from this study were released previously by the company .
bionovo, inc. (otc link platform: bnvi. pk) today announced that it will need to obtain substantial additional funding to achieve its objectives of internally developing drugs. the company reduced its workforce by over 90% . the remaining management of the company will receive reduced cash compensation until either adequate financing can be obtained or the company is sold. the company cannot make any assurances about either of these events. as previously announced, management and the board of directors are continuing to explore strategic options for the company. management is currently reviewing the status of the ongoing clinical trial for menerba .
menerba is a first - in - class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms,  said isaac cohen, bionovos chairman and chief executive officer. we want to do everything necessary to bring menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. now that we have agreements with the fda and the ema (the european medicines agency) on the overall development of menerba, we have accelerated discussions with potential partners to successfully bringing menerba to market. 
for bionovo, the drug discovery and development company in emeryville, calif. , that' s behind bzl101, there' s hope too. the trial is the first fda - validated clinical study of a potential cancer drug derived from a chinese medicinal herb, says dr. mary tagliaferri, a co - founder of the company, former practicing acupuncturist and a breast - cancer survivor .
sixty - two percent of chemotherapy drugs come from natural products, and plants have been the basis of almost every new class of medication ,
she says .
it makes sense that these plants can act as anticancer agents .
large clinical trials, such as the hers and the whi, elucidated serious safety concerns associated with hormone therapy. these results have led to a dramatic drop in the use of estrogens ,
said isaac cohen, chairman and ceo of bionovo, inc .
for this reason, it is important to develop safer alternatives for treating menopausal symptoms currently affecting 30 million women in the us. our results indicate menerba is effective and safe for the treatment of hot flashes and we are eager to move forward with the development of this drug. clearly, menerba has the potential to help millions and reach blockbuster sales soon after market launch .
bionovo, inc. , a development stage company, engages in the discovery and development of drugs in the areas of cancer and women? s health primarily in the united states. it develops drugs to treat breast and ovarian cancers, and for menopause. the company? s product and drug pipeline includes mf101, a selective estrogen receptor beta agonist, which is designed to alleviate the symptoms of menopause, including hot flashes, night sweats, and bone mineral loss; and bzl101, an apoptosis inducing factor translocator / activator, which is used as an anticancer agent for breast and ovarian cancers, as well as used for the treatment of other solid tumors. in addition, its drug pipeline, which is not entered human clinical trials includes aa102, an apoptosis inducer, which is used as an anticancer agent that attenuates mitochodrial membrane potential to cause a cytochrome c release and caspase activation to induce apoptosis; and vg101, vasodilator and an antimicrobial agent, which is an intra - vaginal gel for the treatment of postmenopausal vaginal dryness. the company has collaboration with the university of california at san francisco; university of california at berkeley; university of california at davis; university of texas, southwestern; and university of colorado health sciences college. bionovo was founded in 2002 and is headquartered in emeryville, california .
prior to joining nektar, she was a clinical and regulatory consultant to intermune before its acquisition by roche. she also served as chief medical officer at kanglaite usa, a privately - held biotechnology company which develops oncology drug candidates in multiple solid tumor settings. dr. tagliaferri was also co - founder and president and chief medical officer of bionovo where she led the company' s clinical drug development strategy and global regulatory affairs, led data management and biostatistics, and oversaw clinical operations and compliance. dr. tagliaferri received the 2012 state of california woman of the year award for her advancements of clinical research in women' s health and her mentorship of women in the biotechnology field .
the fda at least is eager to see more studies of botanical treatments of cancer .
we' re not opposed to chinese medicine ,
says dr. shaw chen, botanical review team leader at the fda .
we just like to see clinical studies that meet our standards .
chen agrees it can be tough to study the pharmacological activity of botanical compounds or to ensure consistency in quality, but bionovo' s efforts, if fruitful, may help pave the way for other research .
a successful application to market for a cancer drug based on chinese medicine will be encouragement to the industry ,
he says .
i think the industry is watching for the first success story .
we are encouraged by the results of the company' s second phase 1 trial in women with advanced breast cancer and feel the oncology community is equally enthusiastic about bezielle as our manuscript was accepted by the most widely read breast cancer specific peer reviewed journal in two days ,
said mary tagliaferri, president and chief medical officer of bionovo .
there are currently over 160, 000 women in the united states living with advanced breast cancer who are eagerly awaiting an oral anticancer drug that can extend life without profoundly diminishing quality of life. we believe bezielle will be an important new anticancer agent because its biological selectivity allows the drug to kill cancer cells without affecting normal cells resulting in dramatically fewer side effects .
we had a very positive meeting with the fda on our clinical program for menerba. as anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non - clinical studies necessary for new drug application (nda) submission for a non - estrogen drug such as menerba. they also provided useful suggestions for improving the clinical trial protocols,  said mary tagliaferri, m. d. , bionovos president and chief medical officer. while we are awaiting the formal minutes from the fda meeting, we are moving forward to implement the agencys suggestions and have forwarded the approved clinical trial design to our investigators and their investigational review boards, or irbs. 
in the age of sequential monotherapy as the treatment approach for women with metastatic breast cancer, bezielle is one of the most exciting new therapies under investigation today ,
said banu arun, m. d. , department of breast medical oncology, division of cancer medicine, university of texas, m. d. anderson cancer center, houston, texas .
at our center, where over 3, 000 women are newly diagnosed with breast cancer each year, there is great patient demand for oral drugs with minimal toxicities for the treatment of any stage breast cancer. bezielle is the exact type of drug our patients are seeking and the favorable clinical results in bionovo' s two early stage clinical trials among a heavily pretreated patient population are extremely encouraging .
bionovo completed a multicenter phase 2, double - blind, placebo - controlled randomized clinical trial evaluating menerba for the treatment of hot flashes in 217 healthy post - menopausal women enrolled at 6 clinical sites in the u. s. the principal investigator of the trial was dr. deborah grady from the university of california, san francisco. menerba showed a statistically significant reduction in the number of hot flashes after 12 weeks of treatment (- 62% , p = 0. 05) and had a statistically significant reduction in nighttime awakenings from hot flashes (- 67% , p = 0. 05). there was no difference in uterine bleeding between treatment groups and placebo, and no uterine abnormalities were observed during the study. the only side effect observed was mild loose stools (12% in treatment group vs. 3% in the placebo group). to date, no significant toxicities have been observed in any of the animal studies with doses ranging from 2000 mg / kg / day in dogs to 16, 000 mg / kg / day in rodents .
tagliaferri' s interest in ban zhi lian, which has traditionally been used to treat swellings, sores and fever, was sparked in 1996 by a fellow acupuncturist, isaac cohen, who would later become a co - founder of bionovo. at that time, cohen had been treating, for a decade, women who were battling breast cancer with conventional medicines and had run out of treatment options .
in their exhaustion and desperation, they were trying to find an alternative treatment that was not so harsh ,
says cohen, who often prescribed herbs to be prepared as teas to ease the side effects of chemo and hormone therapy. but the patients' oncologists, says cohen, discouraged them from trying anything new .
they' d say chinese medicine was quackery and that there was no evidence it worked ,
he says. still, cohen observed that many of the women to whom he gave chinese herbs, including ban zhi lian, responded well to the herbs and even experienced a relatively good quality of life .
at first i chucked it to luck ,
he says .
but then you see it' s not just luck. and then you ponder why .
menerba is an oral botanical 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 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 .
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 .
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the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. listing a study does not mean it has been evaluated by the u. s. federal government. read our disclaimer for details .
to conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total n = 40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal ph > 5. 0 and > 20% parabasal vaginal epithelial cells .
the optimal dose of vg101 based on the highest of 4 proposed dose levels that is not associated with unacceptable toxicity during 12 weeks of treatment. toxicity will be based on national cancer institute (nci) common toxicity criteria for adverse events (ctcae), version 3. unacceptable toxicity will be defined as the occurrence of any grade 3, 4, of 5 toxicity that is possibly or probably associated with study drug or any other unacceptable toxicity as determined by the data and safety monitoring board .
choosing to participate in a study is an important personal decision. talk with your doctor and family members or friends about deciding to join a study. to learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. for general information, learn about clinical studies .
postmenopausal documented by: (a) at least one year of amenorrhea; (b) 6 - 12 months of amenorrhea with serum fsh > 40 iu / ml; (c) 6 weeks post - surgical bilateral oophorectomy with or without hysterectomy, or (d) hysterectomy with serum fsh levels > 40 iu / ml .
willing to use an intravaginal cream containing chinese herbs for the treatment of vaginal symptoms .
abnormal pap smear or pelvic examination within the last 9 months suggestive of cancer .
any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening pap smear) .
use of any vaginal moisturizer (replens, ky silk - e, astroglide silken secret, senselle) within 30 days of screening .
use of any oral, transdermal, vaginal, or systemic estrogen or estrogen / progestin product within 30 days of screening .
any medical or psychiatric condition that, in the investigator' s opinion, would preclude the participant from completing questionnaires or measures, adhering to the protocol or completing the trial, including limited english literacy, severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia .
to learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor .
contact: holly richter, m. d. , phd 205 - 934 - 3180 hrichter @ urltoken
contact: deborah grady, m. d. , mph 415 - 353 - 9748 deborah. grady @ urltoken
the chinese herb ban zhi lian may not be in everyone' s lexicon, but to the 80 women with stage iv metastatic breast cancer, who are participating in the second phase of the bzl101 clinical trials, it represents hope and life .
cohen' s early observations about ban zhi lian may have started out as a hunch, but they may hold up. in 1996, cohen and tagliaferri, along with dr. debu tripathy, then a breast cancer specialist at the university of california, san francisco, co - founded the complementary and alternative medicine program at the university' s carol franc buck breast care center. over the next several years, the trio amassed enough evidence about the herb' s anticancer properties  in lab tests of animals and breast - cancer cells, bzl101 caused apoptosis or cell death, according to tagliaferri  to get a green light from the fda to begin clinical trials .
the researchers conducted phase i trials at buck and at the cancer research network in plantation, fla. their 21 participants had stage iv metastatic breast cancer, which had continued to progress despite an average of four rounds of standard treatment, including chemo and hormone therapy. the patients took 12 g a day of ban zhi lian, a dose that' s three times more concentrated than the amount found in a cup of brewed tea. after about a year, 25% of the patients saw stabilization in their disease for 90 days, and 19% for 180 days. the experimenters say bzl101 works by preventing cancer cells from undergoing glycolysis, a process of glycogen breakdown that accounts for as much as 85% of cancer cells' energy supply .
women with breast cancer have typically sought chinese medical herbalists for relief from the side effects of chemotherapy and radiation or to strengthen and balance their immune systems; some have even hoped for a cure. some women may have been helped; others not. but with so many variables  the broad range of patients, quality and potency of the herbs available, types of formulations prescribed and the expertise of the herbalist  outcomes in informal settings were never a sure thing. and it' s the same kind of variability that has made clinical research so problematic .
even though people are very interested in herbal therapy and a lot of people take herbs, research in herbal therapy is difficult because you' re dealing with a mixture of compounds ,
says tripathy, who is now a clinical professor of internal medicine at the university of texas southwestern medical center in dallas. during the research phase, tripathy says, scientists often attempt to isolate one particular molecule or compound from the herbal extract  and the anticancer activity is lost .
there are herbal extracts in which the anticancer activity is actually due to the synergy between many of the compounds contained in that extract ,
he says .
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the emeryville - based drug developer (pink sheets: bnvi) said the sale of its stock, which closed monday at 6 cents per share, will raise about $ 427, 000. it also will receive about $ 344, 575 if all the warrants are exercised for cash by march 30 into nearly 11. 5 million shares of stock at 3 cents each .
the company’s largest shareholders as of last month were rothsinvest asset management ag and co - founders isaac cohen and mary tagliaferri .
cohen, who is chairman and ceo, received more than $ 1. 3 million in compensation last year, including $ 375, 000 in salary, a $ 9, 000 - plus car allowance and health care and life insurance premiums. that’s roughly the same compensation as tagliaferri, who serves as president and chief medical officer .
“we will require substantial capital resources in order to conduct our operations and develop our therapeutic products, and do not expect that our current cash and cash equivalents will be sufficient to fund our current and planned operations, ” the company said in the sec filing .
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the company does not currently have adequate internal liquidity to meet its cash needs. if sufficient additional funds are not received in the near term, the company may not be able to execute its business plan and may need to further curtail or cease operations .
for cancer and women’s health issues. cohen and colleagues at ucsf and elsewhere examined chinese herbal medicines for their biochemical and cellular effects based upon their traditional use .
the emeryville, ca, company has been developing traditional chinese medicines as fda - approvable drugs for women' s health indications .
thanks, lila – i’m just hoping that someone picks up on the work they’ve done thus far. great people and some very interesting science in there .
the safety zone covers chemical safety issues in academic and industrial research labs and in manufacturing. it is intended to be a forum for exchange and discussion of lab and plant safety and accident information without the fanfare of a news article .
i' m the only one here. i talk to myself... haha
for me: yes $ $ $ $ $ $ here... . go bnviq
up 290% over the last month... . 39. 29% over the
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bionovo ( nasdaq : bnvi.ob ) was an american biotechnology company focused on the discovery and development of botanically derived treatments for women 's health and cancer based in emeryville , california . the company had two drug candidates in u.s. food and drug administration ( fda ) clinical trials - menerba ( formerly known as mf101 ) a selective estrogen receptor beta agonist for hot flashes associated with menopause and bezielle ( formerly bzl101 ) for advanced breast cancer . the company has ceased activity and its stock , although still listed , not moved from 0,00 usd since the end of 2012 . no statement has been made by the management , nor any indication has been given that the company is still active . the last press statement was about the sell of all the technical equipment and lay off of 90 % of the staff . in short words , the company is as good as bankrupted and shut down , although the management never officially admitted it . 
bionovo (nasdaq: bnvi.ob) was an american biotechnology company focused on the discovery and development of botanically derived treatments for women's health and cancer based in emeryville, california. the company had two drug candidates in u.s. food and drug administration (fda) clinical trials - menerba (formerly known as mf101) a selective estrogen receptor beta agonist for hot flashes associated with menopause and bezielle (formerly bzl101) for advanced breast cancer. the company has ceased activity and its stock, although still listed, not moved from 0,00 usd since the end of 2012. no statement has been made by the management, nor any indication has been given that the company is still active. the last press statement was about the sell of all the technical equipment and lay off of 90% of the staff. in short words, the company is as good as bankrupted and shut down, although the management never officially admitted it.
bionovo (nasdaq: bnvi.ob) was an american biotechnology company focused on the discovery and development of botanically derived treatments for women's health and cancer based in emeryville, california. the company had two drug candidates in u.s. food and drug administration (fda) clinical trials - menerba (formerly known as mf101) a selective estrogen receptor beta agonist for hot flashes associated with menopause and bezielle (formerly bzl101) for advanced breast cancer. the company has ceased activity and its stock, although still listed, not moved from 0,00 usd since the end of 2012. no statement has been made by the management, nor any indication has been given that the company is still active. the last press statement was about the sell of all the technical equipment and lay off of 90% of the staff. in short words, the company is as good as bankrupted and shut down, although the management never officially admitted it.