CicloMed Announces First Patient Dosed With Ciclopirox Prodrug in Phase I Trial

CicloMed LLC recently announced that the first patient has been dosed in a Phase I clinical trial. The CPX-POM-001 study is characterizing the safety, dose tolerance, pharmacokinetics and pharmacodynamics of Ciclopirox Prodrug, or CPX-POM, in patients with advanced solid tumors.

Under the leadership of the study’s Principal Investigator, Howard A. “Skip” Burris III, MD, Chief Medical Officer and President, Sarah Cannon Research Institute, the first-in-human trial will enroll patients at several US sites. This initial clinical trial aims to determine the recommended intravenous dose of CPX-POM for subsequent Phase II trials.

“Ciclopirox Prodrug has demonstrated anti-tumor activity in preclinical models of non-muscle invasive and muscle-invasive bladder cancer. There is preclinical evidence for activity in both forms of the disease, particularly in inhibiting the progression from non-muscle invasive to muscle-invasive bladder cancer. This trial represents an important first step in our strategy to evaluate the combined activity of Ciclopirox Prodrug and standard-of-care surgical, chemotherapy and immunotherapy treatments in bladder cancer patients,” said Tammy Ham, President and Chief Executive Officer of CicloMed LLC.

CPX-POM was discovered by researchers at The University of Kansas Cancer Center and KU’s Institute for Advancing Medical Innovation (IAMI). CicloMed was formed in 2016 as a unique public-private partnership between BioNovus Innovations LLC and IAMI. Development of CPX-POM for the treatment of bladder cancer is the lead development program under this partnership. “Our vision is to discover and advance to patients promising new cancer treatments. This achievement represents a major milestone for our program,” commented Roy Jensen, MD, Director of the University of Kansas Cancer Center. For further information, please view the Phase I study’s disclosure page or search for CicloMed or CPX-POM on www.clinicaltrials.gov.

More than 500,000 men and women are living with bladder cancer in the US. Bladder cancer is the fifth most common cancer in Americans and the fourth most common cancer in men. According to the American Cancer Society, about 79,000 new cases of bladder cancer will be diagnosed this year, and 16,800 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 Ciclopirox Prodrug is its lead drug 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.