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PTI G-2535 is a standardized soy isoflavone preparation developed for clinical evaluation in cancer prevention, specifically targeting breast cancer. It consists of a concentrated mixture of unconjugated isoflavones, primarily genistein (139.5 mg), daidzein (74 mg), and glycitein (11 mg) per capsule. As a phytoestrogen, the preparation acts as a selective estrogen receptor modulator (SERM), binding to and activating estrogen receptors (ER-alpha and ER-beta) to influence estrogenic signaling pathways. The formulation was provided by Protein Technologies International via the National Cancer Institute and was evaluated in a Phase I clinical trial led by the University of North Carolina at Chapel Hill. The study focused on the safety, pharmacokinetics, and biological effects—such as DNA damage and apoptosis—of high-dose isoflavone supplementation in healthy postmenopausal women to assess its potential for breast cancer chemoprevention.
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