CicloMed Expands Fosciclopirox Bladder Cancer Trial

CicloMed announced the expansion of its fosciclopirox clinical development program. The fosciclopirox first-in-human Phase 1 trial has been expanded to include patients with muscle-invasive bladder cancer who are ineligible to receive cisplatin chemotherapy. The first patient has been enrolled at The University of Kansas Cancer Center in a study extension with expected recruitment to complete within 12 months. Fosciclopirox is the proposed International Nonproprietary Name for Ciclopirox Prodrug, or CPX-POM.

The milestone follows completion of a first-in-human Phase 1 dose escalation study in 19 advanced solid-tumor patients that gathered safety, dose tolerance, pharmacokinetic and pharmacodynamics data resulting in identification of the fosciclopirox Recommended Phase 2 Dose (RP2D).

"We are excited to launch this expansion cohort study to begin evaluating the antitumor activity of fosciclopirox in a well-defined subgroup of bladder cancer patients," said Tammy Ham, President and Chief Executive Officer of CicloMed LLC. "As a National Cancer Institute (NCI) -designated center, the KU Cancer Center is a strong partner in providing scientific and clinical expertise to support CicloMed’s fosciclopirox drug development program."

Bladder cancer patients selected for the expansion cohort will have tumors that have progressed into the bladder’s muscle layer but not beyond, and who are ineligible for cisplatin chemotherapy due to other medical issues. The standard of care for these patients is cystectomy (surgical removal of the bladder), typically six to eight weeks after diagnosis. Fosciclopirox will be administered as two 21-day treatment cycles prior to cystectomy to evaluate the antitumor activity of fosciclopirox.

"We have designed this study to characterize the activity of fosciclopirox in muscle-invasive bladder cancer patients in a neoadjuvant setting, while providing them with standard-of-care surgical treatment of their disease," said John A. Taylor III, M.D., Co-Leader of the Drug Discovery, Delivery and Experimental Therapeutics progam at the KU Cancer Center, who also is the Principal Investigator for the expansion cohort study. "Bladder cancer patients today face limited options, and treatments often have difficult impacts on their quality of life. This study will provide important data on potential benefits of fosciclopirox, while aiding in planning for subsequent pivotal trials characterizing safety and efficacy."

Nearly 700,000 men and women are living with bladder cancer in the United States, according to the NCI, with more than 80,000 new cases of bladder cancer expected to be diagnosed in 2019 and more than 17,000 deaths this year. Bladder cancer is the sixth most common cancer in the United States.

"This expansion cohort study is an important next step in the development of fosciclopirox," said Scott J. Weir, Ph.D., Acting Chief Scientific Officer of CicloMed and Director of the Institute for Advancing Medical Innovation (IAMI), the KU Cancer Center’s product development arm. "We recently published preclinical data in the peer-reviewed Journal of Pharmacology and Experimental Therapeutics describing that systemic administration of fosciclopirox selectively delivers its active metabolite to the entire urinary tract at concentrations exceeding those required to inhibit cancer cell proliferation. A series of publications are planned describing the drug’s activity in preclinical models of bladder cancer as well as unique mechanisms of action.  Results of the recently completed Phase 1 dose escalation study will be presented next year. Overall, development of fosciclopirox is progressing well."

Fosciclopirox was discovered by scientists at the KU Cancer Center and IAMI. Preclinical studies suggest that the compound inhibits progression of non-muscle invasive to muscle-invasive bladder cancer. CicloMed was formed in 2016 as a public-private partnership between BioNOVUS Innovations LLC and IAMI, with fosciclopirox as the collaboration’s lead development program.

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