Bionovo
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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. Bionovo’s 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, the Company’s 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. Bionovo will soon initiate a Phase 3 trial at 40 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. Bionovo believes 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.
