 | |
| Company type | Public |
|---|---|
| Industry | Biotechnology |
| Headquarters | , United States |
Key people | Isaac Cohen, Founder and CEO, Mary Tagliaferri, Founder, President and CMO |
Number of employees | 8[1] |
| Website | www |
Bionovo (NASDAQ: BNVI.OB) was an Americanbiotechnologycompany focused on the discovery and development of botanically derived treatments for women's health and cancer based inEmeryville,California. The company had multiple drug candidates in U.S.Food and Drug Administration (FDA)clinical trials-Menerba (formerly known as MF101) a selectiveestrogen receptor beta agonist forhot flashes associated withmenopause Seala (formerly VG101) a selective estrogen receptor beta agonist for menopausal vaginal dryness and Bezielle (formerly BZL101) for advancedbreast cancer. The company has ceased activity after filing for Chapter 7 bankruptcy protection in California. Bionovo's stock is no longer listed.
Bionovo usedtraditional Chinese medicine (TCM) as its discovery engine, isolating, purifying and testing potentactive ingredients fromherbs 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,[2][3] and in some cases, has developed syntheticmethods of production. They are developing their drugs in accordance with the U.S. FDA'sbotanical drug guidelines.[4]
Bionovo'sdrug pipeline had two drug candidates in clinical trials and several additional candidates positioned to enter clinical trials upon the receipt of funding or partnership.
Bionovo’s lead drug candidate, Menerba (formerly known as MF101), is a novel selectiveestrogen receptor beta (ERβ) agonist designed to treat vasomotor symptoms (hot flashes) associated withmenopause.[5]
Although Menerba is aselective estrogen receptor modulator (SERM), it is distinct from the other FDA-approved SERMs, such astamoxifen andraloxifene, since these drugs have mixed agonist/antagonist activity and are not selective in transcriptional regulation to one of the two knownestrogen receptor subtypes.
Menerba completed its Phase II clinical trial, showing the drug to be safe, clinically efficacious and well tolerated.[6] The drug will begin its Phase III clinical trial pending FDA approval.[7]
Bezielle (also called BZL101) is an oral drug designed for the treatment of advancedbreast cancer. The drug is derived from the herb, Scutellaria Barbata, which is used intraditional Chinese medicine to treatcancer.[8] Bezielle is selectively cytotoxic to most of twelve breast cancer cell lines examined[3] as well as to a number of cancer cell lines of different tissue origins such as prostate, lung, colon, ovarian and pancreatic cancers.[3][9]
Bezielle’smechanism of action targets diseased cells while leaving normal cells healthy and intact by inhibitingglycolysis production. Normal cells depend primarily on thecitric acid cycle (>85%) and very little onglycolysis (<7%) for energy production. In contrast,cancer cells depend largely onglycolysis (>85%) for energy production.[10] Bezielle induces strongoxidative stress in cancer cells leading to severeDNA 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.[3] Bezielle has completed Phase 1A[10] and 1B[11] clinical trials for advancedmetastatic breast cancer.[12]
Seala (also known as VG101) forvaginal atrophy was approved by the FDA to begin a Phase I/IIclinical trial[13] upon receipt of funding.
BN107 and BN108, both designed to treat advanced breast cancer, are slated to begin Phase I/IIclinical trials upon funding.[14][15]
Bezielle was scheduled to begin a Phase I/IIclinical trial for the treatment ofpancreatic cancer upon funding.[16]