CicloMed (Kansas City, Mo.) has expanded the Phase 1 clinical trial for fosciclopirox, its bladder cancer drug candidate.
The trial has been expanded to include patients with muscle-invasive bladder cancer who are ineligible to receive cisplatin chemotherapy, the company said yesterday. Researchers have enrolled the first patient at The University of Kansas Cancer Center; the study extension is expected to be completed within 12 months.
The study extension comes after completion of a first-in-human Phase 1 dose-escalation study in 19 advanced solid-tumor patients. The study gathered safety, dose tolerance, pharmacokinetic and pharmacodynamics data resulting in the identification of the fosciclopirox recommended Phase 2 dose.
“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,” Tammy Ham, president and CEO of CicloMed, said in a news release.
“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,” Ham said.