Clinical trials for a new bladder cancer therapy show promising interim results. Lead researcher Alvaro Morales says that the breakthrough using the drug Urocidin follows thirty years of his research in this important area.
"I am optimistic about the results of the trial," says Dr. Morales, professor emeritus in the Department of Urology at Queen's University and director of the Queen's University Centre for Applied Urological Research. "Positive results in the next phase of trials will move us very close to a far more effective bladder cancer treatment."
Initial human trials found that Urocidin is effective and much safer than previous treatment options for cases of superficial bladder cancer that is not responsive to Bacillus Calmette-Guérin (BCG) therapy. A recent large North American clinical trial confirmed the initial findings, with 25 per cent of patients becoming disease-free after one year of therapy with the new drug. Patients also tolerated Urocidin well.
Dr. Morales spearheaded BCG as a bladder cancer treatment in the 1970s in collaboration with the Cancer Research Institute of New York. BCG provoked an immune response strong enough to eliminate some bladder cancers without chemicals. It was also the first effective agent approved by the FDA against solid tumors. BCG remains the first choice to treat superficial bladder cancer due to its superior efficacy over chemotherapy drugs; however, as a live bacterium, it has the potential for serious adverse effects.
"There has been a lot of concern about the adverse effects of BCG," explains Dr. Morales. "I've always thought that we should look for something better. Urocidin could be what we're looking for." Until the discovery of BCG as a bladder cancer therapy, the only alternative short of bladder removal was to put chemicals into the bladder.
Urocidin was developed by Bioniche Life Sciences Inc. A second Phase III clinical trial is underway, funded by Bioniche's licensing partner, Endo Pharmaceuticals.
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