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news.Bionovo, a developer of treatments for women's health and cancer, has completed 13 weeks repeat dose animal toxicology studies with Menerba.
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Menerba, an oral botanical, estrogen receptor beta (ER-b) selective drug is designed to treat vasomotor symptoms (hot flashes) associated with menopause.
Menerba at doses far greater than the planned human doses were administered to the animals daily for 13 weeks.
Bionovo said the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells.
Bionovo chairman and CEO Isaac Cohen said prior to Phase 3 initiation they were required by FDA to complete two 13 weeks repeat dose animal toxicology studies.
"We are therefore on track to initiate the Phase 3 in the third quarter of this year," Cohen said.