Bionovo

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.[2] 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.[3]

Bionovo
TypePublic
IndustryBiotechnology
Headquarters
Emeryville, CA
,
United States
Key people
Isaac Cohen, Founder and CEO, Mary Tagliaferri, Founder, President and CMO
Number of employees
8[1]
Websitewww.bionovo.com

Discovery and development platform

Bionovo used traditional Chinese medicine (TCM) as its discovery engine, isolating, purifying and testing potent active ingredients from herbs and other botanicals, then formulating them into products which can be packaged as powders or pills for easy use by patients.

The company identified the active chemical components underpinning the mechanism of action for all of their lead drug candidates,[4][5] and in some cases, has developed synthetic methods of production. They are developing their drugs in accordance with the U.S. FDA's botanical drug guidelines.[6]

Drug pipeline

Bionovo's drug pipeline had two drug candidates in clinical trials and several additional candidates positioned to enter clinical trials upon the receipt of funding or partnership.

Menerba

Bionovo’s lead drug candidate, Menerba (formerly known as MF101), is a novel selective estrogen receptor beta (ERβ) agonist designed to treat vasomotor symptoms (hot flashes) associated with menopause.[7]

Although Menerba is a selective estrogen receptor modulator (SERM), it is distinct from the other FDA-approved SERMs, such as tamoxifen and raloxifene, since these drugs have mixed agonist/antagonist activity and are not selective in transcriptional regulation to one of the two known estrogen receptor subtypes.

Menerba completed its Phase II clinical trial, showing the drug to be safe, clinically efficacious and well tolerated.[8] The drug will begin its Phase III clinical trial pending FDA approval.[9]

Bezielle

Bezielle (also called BZL101) is an oral drug designed for the treatment of advanced breast cancer. The drug is derived from the herb, Scutellaria Barbata, which is used in traditional Chinese medicine to treat cancer.[10] Bezielle is selectively cytotoxic to most of twelve breast cancer cell lines examined[5] as well as to a number of cancer cell lines of different tissue origins such as prostate, lung, colon, ovarian and pancreatic cancers.[5][11]

Bezielle’s mechanism of action targets diseased cells while leaving normal cells healthy and intact by inhibiting glycolysis production. Normal cells depend primarily on the citric acid cycle (>85%) and very little on glycolysis (<7%) for energy production. In contrast, cancer cells depend largely on glycolysis (>85%) for energy production.[12] Bezielle induces strong oxidative stress in cancer cells leading to severe DNA damage, but in normal cells the effect is blunted due to their different metabolic profile. Cancer cells attempt but ultimately fail to repair DNA damage that results in the inhibition of glycolysis and cancer cell death while normal cells remain unharmed.[5] Bezielle has completed Phase 1A[12] and 1B[13] clinical trials for advanced metastatic breast cancer.[14]

Early stage drug candidates

Seala (also known as VG101) for vaginal atrophy was approved by the FDA to begin a Phase I/II clinical trial[15] upon receipt of funding.

BN107 and BN108, both designed to treat advanced breast cancer, are slated to begin Phase I/II clinical trials upon funding.[16][17]

Bezielle was scheduled to begin a Phase I/II clinical trial for the treatment of pancreatic cancer upon funding.[18]

References
  1. "source". Biz Journals. Retrieved 24 July 2012.
  2. Yahoo Finance
  3. Bizjournal.com, Mar 13, 2012
  4. Cvoro, A.; Paruthiyil, S.; Jones, J. O.; Tzagarakis-Foster, C.; Clegg, N. J.; Tatomer, D.; Medina, R. T.; Tagliaferri, M.; et al. (2006). "Selective Activation of Estrogen Receptor- Transcriptional Pathways by an Herbal Extract". Endocrinology. 148 (2): 538–547. doi:10.1210/en.2006-0803. PMID 17095596.
  5. Fong S, Shoemaker M, Cadaoas J, et al. (April 2008). "Molecular mechanisms underlying selective cytotoxic activity of BZL101, an extract of Scutellaria barbata, towards breast cancer cells". Cancer Biology & Therapy. 7 (4): 577–86. doi:10.4161/cbt.7.4.5535. PMID 18305410.
  6. Coombs, Amy (May 30, 2008). "FDA lets botanicals grow into a new sector". San Francisco Business Times.
  7. Grady D, Sawaya GF, Johnson KC, et al. (2009). "MF101, a selective estrogen receptor beta modulator for the treatment of menopausal hot flushes: a phase II clinical trial". Menopause. 16 (3): 458–65. doi:10.1097/gme.0b013e31818e64dd. PMID 19182698.
  8. "Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in Phase II Trial". RxTrials Institute Drug Pipeline Alert. 5 (110). June 5, 2007.
  9. "Bionovo Announces Development Plans For Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings" (Press release). Bionovo. December 4, 2008. Retrieved July 27, 2010.
  10. Can Ancient Herbs Treat Cancer? Time, 15 October 2007.
  11. Herba Scutellaria Barbata (Code C2661) National Cancer Institute Thesaurus.
  12. Rugo H, Shtivelman E, Perez A, et al. (September 2007). "Phase I trial and antitumor effects of BZL101 for patients with advanced breast cancer". Breast Cancer Research and Treatment. 105 (1): 17–28. doi:10.1007/s10549-006-9430-6. PMID 17111207.
  13. Perez, Alejandra T.; Arun, Banu; Tripathy, Debu; Tagliaferri, Mary A.; Shaw, Heather S.; Kimmick, Gretchen G.; Cohen, Isaac; Shtivelman, Emma; et al. (2010). "A phase 1B dose escalation trial of Scutellaria barbata (BZL101) for patients with metastatic breast cancer". Breast Cancer Research and Treatment. 120 (1): 111–8. doi:10.1007/s10549-009-0678-5. PMID 20054647.
  14. Press Release: Bionovo Announces Publication of Positive Results From the Phase 1B Clinical Trial of Bezielle (BZL101) for Metastatic Breast Cancer 24 January 2010.
  15. VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
  16. Press Release: "Bionovo to Present Recent Findings of BN107, its Anticancer Agent, at the 31st Annual San Antonio Breast Cancer Symposium" 12 December 2008.
  17. "BIONOVO INC, Form 8-K, Current Report, Filing Date Mar 12, 2009". secdatabase.com. Retrieved May 15, 2018.
  18. Bionovo's Promising Pipeline Targets Large Potential Markets Seeking Alpha, 18 June 2007.
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