- First-time results from recently completed fosciclopirox Phase I safety, dose tolerance, pharmacokinetics and pharmacodynamics trial in advanced solid-tumor patients
- Initiation of fosciclopirox expansion cohort study in cisplatin-ineligible muscle-invasive bladder cancer patients scheduled for cystectomy
KANSAS CITY, Mo., Feb. 13, 2020 (GLOBE NEWSWIRE) -- CicloMed LLC, a biotechnology company developing novel treatments for bladder cancer, today announced that two posters on clinical trials of its lead investigational drug, fosciclopirox, are being presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) February 13-15 in San Francisco.
Results from the recently completed first-in-human Phase 1 dose escalation study in patients with advanced solid tumors will be presented. The safety, dose tolerance, pharmacokinetics and pharmacodynamics of fosciclopirox were characterized in 19 advanced solid-tumor patients across eight dose cohorts, resulting in the identification of the Recommended Phase 2 Dose (RP2D), currently being evaluated in the expansion cohort study described below. (Abstract No. 518, Poster J19, Session B, 12:15-1:45 p.m. February 14, is available here.)
A second poster describes the fosciclopirox Phase I expansion cohort study in cisplatin-ineligible muscle-invasive bladder cancer (MIBC) patients currently underway at two U.S. sites. This “window of opportunity” trial is characterizing the safety, dose tolerance, pharmacokinetics and pharmacodynamics of fosciclopirox administered at the RP2D in 12 MIBC patients scheduled for cystectomy. (Abstract No. TPS604, Poster N22, Session B, 12:15-1:45 p.m. February 14, is available here.)
Fosciclopirox was discovered by scientists at The University of Kansas Cancer Center (KU Cancer Center), a National Cancer Institute (NCI) designated cancer 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.
“We are pleased to be able to share our progress on this potential new treatment for non-muscle invasive and muscle invasive bladder cancer with the research and clinical community at ASCO-GU. The first-in-human Phase I dose escalation study demonstrated fosciclopirox was well tolerated, achieved significant systemic and urinary tract concentrations of its active metabolite, ciclopirox, at well-tolerated doses, with evidence of pharmacologic activity,” said Scott J. Weir, Ph.D., Acting Chief Scientific Officer of CicloMed and Director of IAMI. “The expansion cohort study now underway provides an opportunity to characterize the pharmacologic activity of fosciclopirox directly in bladder tumor tissue in a neoadjuvant setting.”
Led by Principal Investigator, John A. Taylor III, MD, MS, at KU Cancer Center, the MIBC expansion cohort study involves MIBC patients who are scheduled for cystectomy but ineligible for neoadjuvant cisplatin chemotherapy. Fosciclopirox is being administered at the RP2D as two 21-day treatment cycles following diagnosis but prior to cystectomy. The study is underway at KU Cancer Center and the Sarah Cannon Research Institute at HealthONE in Denver.
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 fourth most common cancer among men and sixth most common cancer among women in the United States.
About CicloMed LLC
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 subsidiary of BioNOVUS Innovations LLC, a Kansas City-based firm committed to investing in individuals and organizations who are transforming healthcare and bringing novel solutions to reality. Portfolio companies have developed new enabling technologies, pharmaceuticals and delivery models that are transformative. For more information, visit www.ciclomed.com.
For further information, contact:
CicloMed media inquiries: Dick Johnson, 913.649.8885, dick@johnsonstrategic.com
CicloMed / BioNOVUS partnering: Tammy Ham, 816.949.8721, info@bionovus.com