A new international study conducted at the urology department of the Shaare Zedek Medical Center in Jerusalem is reporting encouraging results in the treatment of high-risk non-muscle invasive bladder cancer (NMIBC), with researchers suggesting the findings could potentially influence standard clinical approaches worldwide.
According to the study data, approximately 95% of patients achieved a complete response, with full disappearance of the tumor observed after just three months of treatment. After one year of follow-up, 76% of participants remained disease-free.
Particularly notable results were recorded among patients who had developed resistance to the standard BCG therapy and were otherwise facing the prospect of bladder removal surgery. In this subgroup, 80% of patients showed complete remission at the one-year mark.
Importantly, the researchers reported no cases of progression to invasive disease during the follow-up period, and none of the patients required a cystectomy.
The study evaluated a novel treatment known as NDV-01, which is based on a biodegradable polymer gel administered into the bladder. The gel forms a sustained drug reservoir that releases two chemotherapy agents-gemcitabine and docetaxel-continuously over a 14-day period.
Researchers say this delivery method allows prolonged exposure of the tumor to the active drugs while reducing the need for repeated procedures and more complex treatment regimens currently in use.
The treatment also demonstrated a favorable safety profile. No serious adverse events were recorded, and side effects were generally mild, primarily involving temporary burning during urination. All participants completed the treatment without withdrawing from the study.
Findings were presented at the annual meeting of the American Urological Association. The study was led by Prof. Boris Chertin of Shaare Zedek’s urology and pediatric urology department.
Prof. Chertin described the results as a potentially major shift in bladder cancer care, noting the absence of disease progression and the avoidance of bladder removal among all study participants.
Following the successful Phase II results, Relmada Therapeutics announced preparations to launch large-scale Phase III trials aimed at advancing the therapy toward potential clinical adoption.