Safety and tolerability of DIM-based therapy designed as personalized approach to reverse prostatic intraepithelial neoplasia (PIN) - Abstract

BACKGROUND: It has been shown previously that novel formulation of 3,3'-diindolylmethane (DIM) substance with high bioavailability (Infemin) inhibits tumor development due to the tumor growth rate reduction in the xenograft model of prostate cancer.

Prostatic intraepithelial neoplasia (PIN) is considered to be promising as a personalized and preventive treatment strategy of prostate cancer (PC). We assessed the safety of Infemin in men with PIN and discussed the interim results.

MATERIALS AND METHODS: A total of 14 patients with PIN were enrolled. They were randomized to 900 mg DIM or placebo daily for 3 months. Safety was evaluated by adverse events (AEs), laboratory tests and physical examinations.

RESULTS AND CONCLUSION: The trial revealed that Infemin treatment is associated with minimal toxicity and no serious adverse events when administered orally for 3 months. We noted three adverse events including nausea and diarrhea in two patients (14%). Combined 95% confidence interval (CI) was 1.8%-42.8%. Therapy was continued in all cases of adverse events. Good tolerability of DIM-based formulation allows us to recommend it for further clinical trials among men diagnosed with PIN for its efficacy and long-term safety parameters.

Written by:
Paltsev M, Kiselev V, Muyzhnek E, Drukh V, Kuznetsov I, Pchelintseva O.   Are you the author?
National Research Centre (NRC 'Kurchatov Institute'), 1, Akademika Kurchatova pl., Moscow 123182, Russia; Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia; ZAO 'MiraxBioPharma', 12 Kutuzovsky av., 121248 Moscow, Russia; Moscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, 127473 Moscow, Russia.

Reference: EPMA J. 2014 Oct 8;5(1):18.
doi: 10.1186/1878-5085-5-18


PubMed Abstract
PMID: 25309637

UroToday.com Prostate Cancer Section

E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe