Sarasota Memorial Hospital Launches Gene Therapy Trials for Bladder Cancer Treatment
Key Insights
Sarasota Memorial Hospital (search)'s research institute is participating in two international clinical trials (ABLE-22 and ABLE-32) investigating gene therapy alternatives to bladder removal surgery for non-muscle-invasive bladder cancer patients.
The experimental treatment uses a non-replicating virus to deliver genes into bladder cancer cells, instructing them to produce proteins that boost immune response and directly attack cancer cells.
The trials target patients with intermediate-risk and high-risk NMIBC, conditions that affect 70-80% of all bladder cancer cases and often lead to quality-of-life-impacting surgeries due to high recurrence rates.
Sarasota Memorial Hospital (search)'s Kolschowsky Research and Education Institute has joined two international clinical trials investigating gene therapy as a potential non-surgical alternative for patients with early-stage bladder cancer. The trials, sponsored by Ferring Pharmaceuticals, represent a significant advancement in treating non-muscle-invasive bladder cancer (NMIBC), which accounts for 70% to 80% of all bladder cancers.
Novel Gene Therapy Approach
The experimental treatment employs a non-replicating virus to deliver therapeutic genes directly into bladder cancer cells. Once delivered, these genes instruct the cancer cells to produce proteins that serve multiple anti-cancer functions: boosting the immune system to identify and attack cancer cells, slowing the growth of new blood vessels that feed tumors, and directly killing cancer cells.
Dr. Robert Carey, a urologist with Sarasota Memorial's First Physicians Group and the Brian D. Jellison Cancer Institute, is leading the local research efforts. "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," Carey stated.
Addressing Treatment Challenges
NMIBC presents significant treatment challenges due to high rates of recurrence and progression, often necessitating surgeries that substantially impact patients' quality of life. Some patients with high-grade NMIBC do not respond to current treatments, creating an urgent need for more effective therapeutic options.
The research addresses this critical gap by exploring alternatives to radical cystectomy, a procedure that involves complete bladder removal and significantly affects patients' daily functioning and overall well-being.
Trial Design and Patient Populations
The ABLE-32 trial focuses on patients with intermediate-risk NMIBC and will enroll up to 250 participants across 100 to 150 sites in Europe and North America. Eligible participants must be at least 18 years of age and have a confirmed diagnosis of intermediate-risk NMIBC.
The ABLE-22 trial targets patients with high-risk NMIBC and plans to enroll up to 454 participants at approximately 120 sites across Asia, Australia, Europe, and North America. This study requires participants to be at least 18 years old, diagnosed with high-grade NMIBC with carcinoma in situ (CIS), and have previously received at least two courses of BCG immunotherapy without adequate response.
Research Participation
Patients interested in learning more about these studies or determining their eligibility can contact the Sarasota Memorial research team at (941) 917-2225 or researchinstitute@smh.com. The trials represent part of a broader international effort to develop more effective, less invasive treatment options for bladder cancer patients worldwide.