Bad news for Bionovo and herbal drug development

A pharmacognosy colleague contacted me on Friday morning with word that the botanical drug development company Bionovo was closing its chemistry group. Well, the news is actually worse as judging from this 8 pm Friday press release:
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 can not 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. 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.
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 identifying herbal extracts 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. 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.

The Emeryville, CA, company has been developing traditional Chinese medicines as FDA-approvable drugs for women's health indications.

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. (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.) 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. 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. 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. Best wishes to everyone affected by these changes at Bionovo.  

Author: David Kroll

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  1. A sad story, David. Thanks for sharing it.

    • 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.