When Mary Tagliaferri, MD, L.Ac. and Isaac Cohen, OMD, L.Ac. co-founded the Complementary and Alternative Medicine Program at the University of California, San Francisco's Carol Franc Buck Breast Care Center and opened the first traditional Chinese medicine clinic at UCSF, their plan was straight forward: employ state of the art technology to rigorously identify and test the active ingredients in traditional Chinese medicine herbs and botanicals. Little did they know that 15 years later they would be working with the FDA to test oral botanical drugs for major medical indications.
Tagliaferri and Cohen's plans shifted because their lead candidates, all derived from TCM, worked even better than they anticipated to treat breast cancer and menopausal hot flashes.
Ban Zhi Lian, long used in TCM to treat breast cancer, was discovered to have selectively cytotoxic effects on human cells, mice, and finally, women with advanced breast cancer. In trials using the herb, the evidence of tumor shrinkage and extended life spans merited advanced clinical trials, especially, as it worked without the life threatening toxicity which is inherent to available conventional treatments for advanced breast cancer.
Cohen and Tagliaferri's menopausal hot flash compound, Menerba, derived from 22 TCM herbs and botanicals, proved to be clinically effective in early trials in the lab, and had no serious side effects.
Based on the success of their early studies at UCSF, Cohen and Tagliaferri co-founded Bionovo, a company dedicated to the development of TCM derived compounds into FDA approved drugs for unmet needs in women's health and cancer.
Building a bridge between Eastern and Western medicine made sense. The two sides make up for each other's shortcomings and support each other's strengths. TCM's strengths are: a deep stock of potential drug candidates to investigate with 4,000 years of documentation on their known application, safety and efficacy. Conventional medicine's strengths were: A rigid, formulaic approach to drug development, resulting in robust statistical data regarding a drug's efficacy, safety and tolerability.
There were also shortcomings. TCM's shortcomings are that is not well known to the general public and is often not covered by health insurance. Although it has a 4,000-year-old written history, TCM has not been subjected to the rigorous scrutiny and consistency requirements, which FDA approved synthetic or biological drugs have. The mechanisms of action in TCM compounds have not been scientifically identified. Conventional medicine's shortcomings are that Western medicine often takes a sledgehammer approach to healing. The FDA approved treatments available for menopausal hot flashes and breast cancer come with deadly side effects.
Bionovo's mission excited investors and they received funding to move their lead candidates through Phase 1 and 2 clinical trials.
With funding secured and scientific leaders in oncology, endocrinology, thermoregulation, estrogen receptor biology and dozens of other fields on board, Bionovo has now identified the mechanisms of action in their lead drugs, and pioneered new discovery platforms in order to rapidly identify specific, sensitive automated quantification of the active pharmaceutical compounds, condense and concentrate the herbs, reduce fiber mass, and ensure standardization of each ingredient to be in accordance with the FDA's strict standards.
It has been nine years since Tagliaferri and Cohen founded Bionovo. And the trials for Bah Zan Li (now known as Bezielle) and Menerba (formerly called MF101) have advanced with positive results and shown continued excellent safety and tolerability profiles. The trial results and discoveries along the way continue to generate great interest in medical and scientific arenas.
Soon, Bionovo expects to enroll 80 women with advanced metastatic breast cancer into a Phase 2 trial for Bezielle at esteemed sites such as the MD Anderson Cancer Center, UCSF, Duke and the Memorial Cancer Institute.
Menerba completed a Phase 2 trial for hot flashes in 217 menopausal women for their much more complex compound with positive results in 2007. About 92 percent of the participants in the trial took all of their study medication, an extraordinarily high compliance rate and no serious side effects were detected. (All currently available conventional treatments for hot flashes carry the risk of heart attacks, strokes, cancer and other deadly side effects).
The clinical trials of Menerba and Bezielle represent the first time that the FDA's botanical guidance has been used for oral botanical drugs in major indications.
This is among the first times FDA has agreed to a manufacturing process that has multiple ingredients and multiple actives - this is previously unheard of.
Recently, yet another milestone was marked, which paved the way for more TCM derived drug development: in October 2010, the FDA accepted Bionovo's manufacturing plan for Menerba to move into Phase 3 clinical trials. Unlike synthetic or biologic drugs, it is not feasible to identify every active compound and interaction between compounds in a 22-herb formula. The FDA's acceptance of Menerba's manufacturing plan - even though they haven't identified every active compound in the formula - shows an increased acceptance for a holistic approach by the FDA, which will open doors for more traditional Chinese medicine treatments to be tested. The European Medical Agency (EMA), the European equivalent of the FDA, also met with Tagliaferri and Cohen and gave them enthusiastic final direction and advice on the initiation of full scale clinical trials in Europe next year.
Wulf Utian, the founder and president emeritus of the North American Menopause Society will be the principle investigator on Menerba's three month trial. The trials will take place at 40 sites throughout the US and 1,200 women who suffer from severe (<50/week) menopausal hot flashes will participate in this double blind placebo controlled dose.
The results to date have shown there is great potential for a whole new branch of effective remedies for medical conditions with no safe treatments at this time. This is an exciting time for traditional Chinese medicine, as we use modern technology to bring it into the light and unlock its ancient secrets.
References
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