Bionovo, Inc (NASDAQ:BNVI) Management Interview

Bionovo, Inc
President: Mary Tagliaferri


Bionovo is a drug discovery and development company focused on developing safe and effective drugs for the treatment of unmet medical needs in women’s health and cancer. Our mission is to improve the quality of women’s health and defeat life-threatening cancers.

Improving Women’s Health
Of the 40 million women in America who are of menopausal age, an estimated 75% to 85% experience significant and unpleasant side effects due to declining and fluctuating hormone levels. These problems include hot flashes, vaginal dryness, cognitive impairment, depression, mood swings, and infections, as well as weight gain. Existing therapies represent a multi-billion dollar market but are, unfortunately, ineffective, unsafe, or both. Bionovo is striving to provide a safe, reliable, and clinically proven therapy to fill this unmet need.

Menerba, our selective estrogen receptor beta agonist, is a proprietary oral formulation of 18 botanically derived active pharmaceutical ingredients designed to reduce the frequency and severity of menopausal hot flashes. This product candidate completed a randomized, double-blind, placebo-controlled Phase 2 clinical trial in 2007, with very encouraging results. The higher dosage reduced 55% of all hot flashes and 62% of moderate-to-severe hot flashes. We will soon initiate a Phase 3 trial at 20 U.S. clinical sites and intend to follow this with a second Phase 3 trial upon selection of a commercialization partner.

While menopausal hot flashes are transitory in nature, vaginal atrophy, also known as “vaginal dryness”, persists, often worsens and leads to infections if left untreated. Approximately 40% of perimenopausal and 50% of postmenopausal women suffer from this condition. We believe that Seala, another selective estrogen receptor beta agonist – formulated as an intra-vaginal suppository – may make a significant improvement in the health and quality of life for those suffering from vaginal dryness. Preparations are under way to begin Phase 1/2 testing.

Conquering Cancer
Breast cancer is the second leading cause of cancer deaths in the United States, and more than 200,000 new cases are diagnosed each year. Although survival rates are improving, conventional approaches to breast cancer therapy have severe side effects and eventually become ineffective in controlling advanced-stage disease. Furthermore, cancer cells that evade treatment tend to spread to other parts of the body. As a result, breast cancer not only takes more than 40,000 lives annually, it also haunts survivors with the prospect of recurring disease and repeated bouts of difficult-to-tolerate therapy.

Bezielle offers the potential to make a significant difference in treatment outcomes. This orally delivered anti-cancer agent has a novel mechanism of action which takes advantage of the metabolic differences between cancer cells and normal cells. It selectively inhibits a biological process that supplies more than 85% of the energy needed by cancer cells, thereby damaging their DNA and causing them to die. Normal cells remain healthy since they rely on a different metabolic pathway.

In 2007, we initiated an open label, multi-center Phase 1/2 trial of Bezielle for the treatment of advanced metastatic breast cancer. Previous studies suggest that Bezielle may have a preferential effect on hormone-independent cancers, which affect approximately 40% of breast cancer patients and currently have few treatment options.

A Novel Discovery Engine
Tapping into a deep knowledge of biological mechanisms and traditional Chinese medicine as our discovery engine, we isolate, purify and test potent active ingredients from herbs and other botanicals, then formulate them into novel drug products which can be packaged as powders or pills for easy use by patients. We have identified the active chemical components underpinning the mechanism of action for all of our drug candidates, and in some cases, we have developed synthetic methods of production. Working in accordance with the FDA’s botanical drug guidelines, we leverage the favorable safety profile of select plant extracts to accelerate our candidate drugs through pre-clinical studies and move them rapidly into clinical trials.

A Deep Pipeline
We are developing a deep, diverse pipeline of additional drug candidates in both women’s health and cancer. For example, two additional anti-cancer agents, BN107 and BN108, for the treatment of advanced breast cancer are currently in preclinical development, and have extensive scientific support. All of our drug candidates have been internally discovered and developed using our proprietary biological and chemical techniques.

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