PMID- 25309637
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141013
LR  - 20211021
IS  - 1878-5077 (Print)
IS  - 1878-5085 (Electronic)
IS  - 1878-5077 (Linking)
VI  - 5
IP  - 1
DP  - 2014
TI  - Safety and tolerability of DIM-based therapy designed as personalized approach to 
      reverse prostatic intraepithelial neoplasia (PIN).
PG  - 18
LID - 10.1186/1878-5085-5-18 [doi]
AB  - 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.
FAU - Paltsev, Mikhail
AU  - Paltsev M
AD  - National Research Centre (NRC 'Kurchatov Institute'), 1, Akademika Kurchatova 
      pl., Moscow 123182, Russia.
FAU - Kiselev, Vsevolod
AU  - Kiselev V
AD  - Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, 
      Russia.
FAU - Muyzhnek, Ekaterina
AU  - Muyzhnek E
AD  - ZAO 'MiraxBioPharma', 12 Kutuzovsky av., 121248 Moscow, Russia.
FAU - Drukh, Vadim
AU  - Drukh V
AD  - Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, 
      Russia.
FAU - Kuznetsov, Igor
AU  - Kuznetsov I
AD  - Moscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, 
      127473 Moscow, Russia.
FAU - Pchelintseva, Olga
AU  - Pchelintseva O
AD  - Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, 
      Russia.
LA  - eng
PT  - Journal Article
DEP - 20141008
PL  - Switzerland
TA  - EPMA J
JT  - The EPMA journal
JID - 101517307
PMC - PMC4193909
OTO - NOTNLM
OT  - 3,3'-Diindolylmethane
OT  - Bioavailability
OT  - Infemin
OT  - Molecularly targeted treatment
OT  - Personalized medicine
OT  - Preclinical trials
OT  - Prostate cancer
OT  - Prostatic intraepithelial neoplasia
OT  - Safety
OT  - Targeted prevention
OT  - Tolerability
EDAT- 2014/10/14 06:00
MHDA- 2014/10/14 06:01
PMCR- 2014/10/08
CRDT- 2014/10/14 06:00
PHST- 2014/08/08 00:00 [received]
PHST- 2014/08/26 00:00 [accepted]
PHST- 2014/10/14 06:00 [entrez]
PHST- 2014/10/14 06:00 [pubmed]
PHST- 2014/10/14 06:01 [medline]
PHST- 2014/10/08 00:00 [pmc-release]
AID - 1878-5085-5-18 [pii]
AID - 10.1186/1878-5085-5-18 [doi]
PST - epublish
SO  - EPMA J. 2014 Oct 8;5(1):18. doi: 10.1186/1878-5085-5-18. eCollection 2014.