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

EPMA Journal

Olga Pchelintseva²  Igor Kuznetsov¹  Vadim Drukh²  Ekaterina Muyzhnek³  Vsevolod Kiselev²  Mikhail Paltsev⁴ 

[1] Moscow State Medical Stomatological University (MGMSU), Delegatskaya St. 2/1, 127473 Moscow, Russia;Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, 117198 Moscow, Russia;ZAO ‘MiraxBioPharma’, 12 Kutuzovsky av., 121248 Moscow, Russia;National Research Centre (NRC ‘Kurchatov Institute’), 1, Akademika Kurchatova pl., Moscow 123182, Russia

关键词: Personalized medicine;    Prostate cancer;    Prostatic intraepithelial neoplasia;    Tolerability;    Safety;    Targeted prevention;    Molecularly targeted treatment;    Bioavailability;    Preclinical trials;    Infemin;    3,3′-Diindolylmethane;   

Others  :  1136550
DOI  :  10.1186/1878-5085-5-18

 received in 2014-08-08, accepted in 2014-08-26,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Paltsev et al.; licensee BioMed Central Ltd.

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