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Madrid, Spain – A pilot study presented at the European Association of Urology (EAU) Congress in Madrid has revealed that a second tuberculosis (TB) vaccination, administered after surgery, significantly boosts immune response and reduces cancer recurrence in patients with non-muscle invasive bladder cancer.

The RUTIVAC-1 Trial, involving 40 patients, explored the efficacy of the RUTI vaccine, a non-live TB vaccine, in conjunction with standard treatment. Patients typically receive Bacillus Calmette Guerin (BCG) inoculation directly into the bladder following tumor removal. However, recurrence rates remain high, with up to 50% of patients experiencing a return of the cancer.

The study’s results were striking. Patients who received the RUTI vaccine demonstrated a significantly enhanced immune response compared to the control group, which received standard treatment alone. Notably, after five years, all patients in the RUTI group were cancer-free, compared to 13 out of 18 patients in the control group.

“We expected that the RUTI vaccine would improve the immune response for patients, but we didn’t know what effect this might have on cancer progression over five years,” said Principal Investigator, Dr. Cecilia Cabrera, of IrsiCaixa and IGTP, Barcelona. “It was very surprising for us to see such a vast improvement in cancer progression even with such a small group of patients.”

The RUTI vaccine was also well-tolerated, with patients experiencing only mild reactions at the injection site and no systemic adverse effects.

Non-muscle invasive bladder cancer, which affects the bladder lining, is an early-stage cancer. It is important to note that bladder cancer is the ninth most common cancer worldwide.

Joost Boormans, Professor of Urology at Erasmus University Medical Center, The Netherlands, praised the study as “well-conducted” and noted the “promising results.” He also highlighted the minimal burden on patients, requiring only two additional injections.

Despite the encouraging findings, researchers emphasize that this was a pilot study. A larger, more comprehensive trial is necessary to validate these results before the treatment can be considered for widespread clinical use.

RUTI is under development as a therapeutic vaccine against tuberculosis by Archivel Farma SL. Its application as an immunotherapeutic agent for bladder cancer is a collaborative effort between IrsiCaixa, IGTP, and Archivel Farma.

Disclaimer: This article is based on preliminary findings from a pilot study presented at a medical congress. The results should be interpreted with caution. Further research, including larger clinical trials, is necessary to confirm the efficacy and safety of the RUTI vaccine for bladder cancer treatment. This information should not be considered medical advice. Always consult with a qualified healthcare professional for any health concerns or before making1 any decisions related to your health or treatment.2

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