CicloMed Announces Initiation of Phase 1B Trial of Fosciclopirox in Newly Diagnosed & Recurrent Urothelial Cancer Patients

CicloMed LLC recently announced that the Phase 1B clinical trial of fosciclopirox for the treatment of bladder cancer is now open.

“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 of 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 2 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’re on the right path.”

The Phase 1B trial is being conducted at The University of Kansas Cancer Center under the leadership of John A. Taylor III, MD, MSc, Director of Urologic Research and co-leader of the Drug Discovery, Delivery and Experimental Therapeutics Research Program and founder and director of the Leo and Anne Albert Institute for Bladder Cancer Care and Research.

“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.

CicloMed presented results from its completed fosciclopirox first-in-human Phase 1 dose escalation study in advanced solid tumor patients (NCT03348514) at ASCO-GU 2020. In addition, the company announced at that time it had opened a Phase 1 expansion cohort study (NCT04608045) at three US sites evaluating fosciclopirox in a neoadjuvant setting in muscle-invasive bladder cancer patients scheduled for cystectomy. The Phase 1 expansion cohort study is expected to complete enrollment by September 2021.

Fosciclopirox was discovered by scientists at the NCI designated cancer center headquartered at the University of Kansas Medical Center, and the Institute for Advancing Medical Innovation (IAMI), the cancer center’s product development enterprise. CicloMed was formed in 2016 as a public-private partnership between BioNovus Innovations LLC and IAMI, with fosciclopirox as the partnership’s lead drug development candidate.

More than 500,000 men and women are living with bladder cancer in the United States.  Bladder cancer is the seventh-most common cancer in Americans and the fourth most common cancer in men. According to the American Cancer Society, about 81,400 new cases of bladder cancer will be diagnosed this year, and 17,980 deaths are expected due to the disease. Of all known malignancies, bladder cancer has the highest recurrence rate, and bladder cancer also has the highest lifetime treatment costs per patient of all cancers.

CicloMed is a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, and fosciclopirox (formerly Ciclopirox Prodrug, CPX-POM) is its lead drug development candidate. CicloMed is a portfolio company of BioNovus Innovations LLC, a unique venture formed to invest in individuals and organizations that are transforming healthcare. BioNovus is charting a new path with the financial investment and commitment to bring novel solutions to reality.

The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally-accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Masonic Cancer Alliance.

The vision of the Institute for Advancing Medical Innovation (IAMI) at The University of Kansas Cancer Center is to develop, demonstrate and disseminate medical innovations that change the standard of care for pediatric, adolescent and adult patients suffering from diseases including cancer and rare diseases. Its mission is to discover drugs, diagnostics and medical devices with clear paths to market. For more information, visit www.kumc.edu/iami.html.