Preclinical Efficacy Evaluation of the Lipid-Based SMEDDS Formulation of DIM, BR-9001,

Iit Research Institute, Chicago IL

Investigators

Abstract

Diindolylmethane (DIM) is an anti-inflammatory, anti-proliferative, compound with an extensive history of safety in humans. DIM has shown chemopreventive and chemotherapeutic activity in multiple translational models of prostate and other cancers, and has advanced into clinical trials for patients with prostate cancer, breast cancer and cervical dysplasia. However, the low solubility of pure, crystalline DIM in previous formulations has limited its oral bioavailability and efficacy. A new lipid-based SMEDDS BR-9001 formulation has demonstrated improved oral bioavailability of DIM as compared to the micro-encapsulated BR-DIM formulations previously studied by the Division of Cancer Prevention. The purpose of this Task Order is to evaluate the efficacy of this new lipid-based SMEDDS formulation of DIM in a rodent prostate cancer prevention model.