title: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Research Centre (NRC 'Kurchatov Institute'), 1, Akademika Kurchatova pl., Moscow 123182, Russia.
authors.forename: Mikhail
authors.initials: M
authors.lastname: Paltsev
authors.affiliation: Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
authors.forename: Vsevolod
authors.initials: V
authors.lastname: Kiselev
authors.affiliation: ZAO 'MiraxBioPharma', 12 Kutuzovsky av., 121248 Moscow, Russia.
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Muyzhnek
authors.affiliation: Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
authors.forename: Vadim
authors.initials: V
authors.lastname: Drukh
authors.affiliation: Moscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, 127473 Moscow, Russia.
authors.forename: Igor
authors.initials: I
authors.lastname: Kuznetsov
authors.affiliation: Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia.
authors.forename: Olga
authors.initials: O
authors.lastname: Pchelintseva
keywords: 3,3′-Diindolylmethane; Bioavailability; Infemin; Molecularly targeted treatment; Personalized medicine; Preclinical trials; Prostate cancer; Prostatic intraepithelial neoplasia; Safety; Targeted prevention; Tolerability