Phase 2 BCG-Unresponsive Bladder Cancer Study Gets the OK to Start Enrollment


Patients with Bacillus Calmette Guérin-unresponsive carcinoma in-situ will be treated at the University of Chicago in a Theralase study.

The University of Chicago Medicine received approval from the Institutional Review Board to begin enrolling patients in a clinical trial from Theralase in June.

Researchers on the trial, which is the Phase 2 Non-Muscle Invasive Bladder Cancer Clinical Study, will enroll and treat 100-125 patients who were diagnosed with Bacillus Calmette Guérin (BCG)-unresponsive carcinoma in-situ. These patients must have also shown intolerance to BCG therapy.

“This technology harnesses the power of near infrared light produced by a laser to destroy localized bladder cancer cells that have not responded to standard of care therapy such as BCG. It gives patients an option to consider before bladder removal,” stated Dr. Piyush Agarwal, Professor of Surgery and Urology, Director of the Bladder Cancer Program and Fellowship Director of Urologic Oncology at the University of Chicago Medicine, in a release.

The first patient to be treated in the study received their treatment at Virginia Urology in Richmond, Virginia.

The study will be Theralase’s seventh U.S.-based clinical study site. The clinical stage pharmaceutical company will submit clinical assessment data on the first 25 patients who are treated in the study to the Food and Drug Administration (FDA) for consideration of breakthrough designation status. So far, 20 patients have been enrolled in the trial, plus three from the phase 1b study.

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