SBIR-STTR Award

We will develop a simple, economical, and rapid in vitro breast cancer cell bioassay that can be used to detect, distinguish between, and determine the bioactivity of estrogens and antiestrogens. To distinguish bctween estrogens and antiestrogens we will monitor differences in their molecular actions on estrogen receptor (ER) binding and activation, ER processing, end product induction, and cell proliferation in intact breast cancer cell lines. The in vitro bioassay will have several commercial applications. It will provide a simple means by which a large panel of drugs, i)laiit extracts, foodstuffs, etc. can be screened rapidly for estrogenic or antiestrogenic (i. e. anticancer) activity. At the clinical level the bioassay will be useful for monitoring serum antiestrogencoiltclit and overall bioactivity in breast cancer patients receiving antiestrogen therapy.Awardee's statement of the potential commercial applications of the research:Acron Biotechnology, Inc. intends to provide the in vitro bioassay, -.IS a commercial service for drug screening programs to detect and determine the bioactivity of estrogens and antiestrogens in natural and synthetic products and as a prognosticator for antiestrogenic therapy of breast cancer.National Institute of Child Health and Human Development (NICHD)

We have developed a "hormonal milieu bioassay" that can be used to measure the relative concentration bioavailability, and net bioactivity of estrogens, progestins and their antagonists (e. g., tamoxifen) in serum or other extracts (e. g., saliva). This bioassay provides a rapid, cost effective means to evaluate if the mechanism of action of a known or uncharacterized drug or foodstuff is mediated through estrogen or progesterone receptor pathways and; therefore, it has the potential of impacting the growth behavior of normal and malignant (e. g., breast and uterine cancers) sex hormone sensitive tissues. The bioassay is designed to distinguish estrogen and progestin agonists from antagonists. It utilizes several estrogen/progestin sensitive human breast cancer cell lines which when exposed to estrogens, antiestrogens, and/or progestins respond in a predictable manner that is unique to the concentration, bioactivity and type of hormone(s) present. Serum can be tested directly for hormonal activity without extraction. The bioassay is based on the effects of hormones on binding and receptor activation, end product induction and cell proliferation.Awardee's statement of the potential commercial applications of the research: This new hormonal milieu bioassay has several immediate applications for use in 1) screening new or uncharacterized drugs, foodstuffs, etc. for hormonal activity, 2) measuring the bioactivity of estrogens/progestins in the serum/saliva of women receiving hormone replacement therapy, 3) monitoring net antiestrogenic activity of tamoxifen in serum/saliva of women receiving this drug for tamoxifen prevention and treatment of breast cancer.National Institute of Child Health and Human Development (NICHD)