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Pharma Tech Outlook | Monday, July 05, 2021
The Phase, 1B trial, is being led by John A. Taylor III, M.D., M.Sc., director of Urologic Research and co-leader of the Drug Discovery, Delivery, and Experimental Therapeutics Research Program, as well as the founder and director of the Leo and Anne Albert Institute for Bladder Cancer Care and Research at The University of Kansas Cancer Center.
FREMONT, CA: CicloMed LLC., a Kansas City-based biotechnology business developing novel treatments for bladder cancer and other malignancies, recently announced that the Phase 1B clinical trial of fosciclopirox for the diagnosis of bladder cancer is now open.
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“We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors,” said Tammy Ham, CEO, CicloMed. “We believe that fosciclopirox provides strong potential to improve treatment outcomes for patients with bladder cancer.”
“In September 2020, CicloMed was awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI), enabling the Phase 1B trial. The SBIR grant validates our work developing fosciclopirox for the treatment of bladder cancer,” commented Ham. “When an external panel of scientists favorably validates your work, you know you are on the right path.”
The Phase, 1B trial, is being led by John A. Taylor III, M.D., M.Sc., director of Urologic Research and co-leader of the Drug Discovery, Delivery, and Experimental Therapeutics Research Program, as well as the founder and director of the Leo and Anne Albert Institute for Bladder Cancer Care and Research at The University of Kansas Cancer Center.
“In addition to supporting the Phase 1B trial, the NCI SBIR grant enables us to study the relationships between targets modulated by fosciclopirox and treatment outcomes in patients receiving standard-of-care,” said Taylor. “We are reviewing our bladder cancer patient registry and biorepository comprising over 1,000 bladder tumor specimens from approximately 500 patients to identify patients who are more likely to benefit from fosciclopirox treatment.”
“Fosciclopirox inhibits the initiation and progression of bladder cancer in preclinical models, at least in part, by acting as a gamma-secretase complex inhibitor, resulting in inhibition of Notch and Wnt signaling pathways,” said Scott Weir, director of the Institute for Advancing Medical Innovation at the University of Kansas Medical Center and CicloMed Acting Chief Scientific Officer. “By partnering with Dr. Taylor, we can explore relationships between Notch and Wnt signaling and response to immunotherapy and chemotherapy treatment. The initiation of this Phase 1B trial enables us to characterize the pharmacologic activity and mechanisms of fosciclopirox action following treatment in urothelial cancer patients,” Weir added.
At ASCO-GU 2020, CicloMed reported findings from its fosciclopirox first-in-human Phase 1 dosage escalation trial in advanced solid tumor patients (NCT03348514). At the time, the business also disclosed that a Phase 1 expansion cohort study (NCT04608045) testing fosciclopirox in a neoadjuvant context in muscle-invasive bladder cancer patients slated for cystectomy had begun at three U.S. sites. Enrollment for the Phase 1 expansion cohort study is planned to be completed by September 2021.
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