A prospective observational study on Electromotive Drug Administration (EMDA®- Mitomycin) in bladder cancer treatment is under process in a major Institute in Thailand in order to prove efficacy of EMDA, medical device produced by Physion Srl in Italy and distributed by Siam Trade Development in Thailand.
The study is the prelude to a project of diffusion of EMDA in all Asia-Pacifica Area.
Bladder cancer is the sixth most commonly diagnosed cancer in the male population worldwide.
Risk factors for bladder cancer are tobacco smoking and occupational exposure to aromatic amines, polycyclic aromatic hydrocarbons, and chlorinated hydrocarbons. In Thailand, in 2020 more than 1.800 cases of bladder cancer have been diagnosed. Survival rate with traditional treatments is 50%.
Approximately 75%-80% of new bladder cancer cases present as non- muscle invasive bladder cancer that may be treated with EMDA, whose usage increases the absorption of Mitomycin of 4-7 times (Di Stasi et al.).
The study will replicate and confirm results achieved by Prof. Dis Stasi’s team: “the exceptionally good results demonstrated a 48-month longer disease-free interval (69 mo. vs. 21 mo., p=0,0012), 12.6 % lower risk of progression (9.3 % vs. 21.9 %, p=0,0047) and 10.9% higher overall survival rate (78.5 % vs. 67.6 %, p=0,045) in the sequential BCG/EMDA®- Mitomycin arm.
Guidelines for study are set in the document “Intravesical sequential bacillus Calmette-Guérin (BCG)/Electromotive Drug Administration (EMDA®- Mitomycin) in patients with high-risk non-muscle-invasive bladder cancer: a prospective observational study”.
Results of study shall be published as soon as available.
EMDA mitomycin in bladder cancer treatment license is held by Siam Trade Development for the kingdom of Thailand.
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