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New Clinical Trials at Sarasota Memorial Explore Gene Therapy Alternative to Bladder Removal Surgery

New Clinical Trials at Sarasota Memorial Explore Gene Therapy Alternative to Bladder Removal Surgery

Wednesday, December 17, 2025

Sarasota Memorial’s Kolschowsky Research and Education Institute is participating in two clinical trials looking at potential non-surgical options for patients with early-stage bladder cancer, known as non–muscle-invasive bladder cancer (NMIBC). NMIBC accounts for 70–80% of all bladder cancers and can be difficult to treat due to high rates of recurrence and progression, oftenDr. Carey leading to surgeries that can significantly impact quality of life.

Some patients with high-grade NMIBC do not respond to current treatments such as BCG immunotherapy, which works by stimulating the immune system to attack cancer cells. To help identify new, more effective, non-surgical options, the research team is participating in the ABLE-22 and ABLE-32 trials, sponsored by Ferring Pharmaceuticals.

Led locally by principal investigator Robert I. Carey, MD, PhD, FACS, a urologist with Sarasota Memorial’s First Physicians Group and the Brian D. Jellison Cancer Institute, both studies are investigating nadofaragene firadenovec as a potential therapy for patients with NMIBC. The treatment uses a non-replicating virus to deliver a gene into the bladder’s cancer cells. This gene instructs the cells to make a protein called interferon alfa-2b (IFNα2b), which can help the body fight the cancer. The protein boosts the immune system to find and attack cancer cells, slows the growth of new blood vessels that feed tumors, and helps kill cancer cells directly.

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The ABLE-32 trial (for patients with intermediate-risk NMIBC) will enroll up to 250 patients at approximately 100-150 sites in Europe and North America. Eligible participants for this study must be at least 18 years of age and be diagnosed with intermediate risk NMIBC.

The ABLE-22 trial (for patients with high-risk NMIBC) will enroll up to 454 patients at approximately 120 sites in Asia, Australia, Europe, and North America. Eligible participants for this study must be at least 18 years of age, be diagnosed with high-grade NMIBC with CIS, and have received and not responded to at least two courses of BCG immunotherapy for NMIBC.

“These trials offer potential non-surgical options for patients with NMIBC that could help preserve quality of life and avoid the life-altering impact of radical cystectomy,” said Dr. Robert Carey.

For more information or to find out if you are eligible to participate in these local studies, contact the Sarasota Memorial research team at (941) 917-2225 or researchinstitute@smh.com. For information about these trials visit:
ABLE-32 trial - https://clinicaltrials.gov/study/NCT06510374
ABLE-22 trial - https://clinicaltrials.gov/study/NCT06545955

About the Kolschowsky Research and Education Institute

Located on the flagship Sarasota Memorial Hospital-Sarasota campus, the Kolschowsky Research and Education Institute serves as a premier hub for medical research and clinical innovation. With dedicated space for research, clinical innovation and graduate medical education, the Kolschowsky Institute provides a collaborative learning environment for physicians, nurses, researchers and students studying new treatments and mastering the latest tools and techniques in patient care. Through state-of-the-art simulation labs, hands-on training programs, and a robust portfolio of clinical studies, Sarasota Memorial and the Kolschowsky Institute play a vital role in advancing medical knowledge, improving patient outcomes, and shaping the future of healthcare in the region. Learn more here.