Ciclopirox “Prodrug” for Bladder Cancer Shows Promise
Bladder cancer is the fifth most common cancer in the United States, with approximately 77,000 new cases and 16,000 deaths annually. It has the highest recurrence rate among all cancers – up to 50 percent of cases may recur within 12 months. Additionally, 25 percent may advance to muscle invasive disease, requiring more aggressive treatment. As such, patients face a lifetime of monitoring and medical care.
Discovered by scientists at The University of Kansas Cancer Center and KU’s Institute for Advancing Medical Innovation (IAMI), the Ciclopirox Prodrug is a bladder cancer drug—a compound that transforms into ciclopirox as the body metabolizes it.
Ciclopirox was first marketed in 1982 as an antifungal agent found in several topical drug products. The team therefore, gave this drug a twist in order to turn it into a cancer fighting drug. It has long been of interest in the oncology community because of strong preclinical evidence that it has some anticancer properties.
But they were faced with a challenge- a clinical trial demonstrated that ciclopirox, given orally, was not a viable treatment.
The researchers, Scott Weir, Pharm.D., Ph.D., director of IAMI, and Shrikant Anant, Ph.D., associate director for cancer prevention
and control research program, then modified this drug to be administered intravenously. The new drug, called Ciclopirox Prodrug, converted to ciclopirox in the bloodstream where it then was selectively delivered to the urinary tract. Further research demonstrated that it was able to kill bladder cancer cells.The drug exhibited wondrous results. “Fantastic results. Not only did the drug have an effect on the cancer cells, but it did not harm surrounding healthy cells,” Anant said.
“This is potentially a game-changer in treating patients with non-invasive bladder cancer. A new and effective drug, which doesn’t require catheterization, is welcomed in a field where care has not advanced much in several decades,” Taylor said.
Under an existing partnership agreement, the University of Kansas Medical Center licensed Ciclopirox Prodrug to BioNovus Innovations LLS. Development is being managed by BioNovus subsidiary CicloMed LLC.
CicloMed is on track to submit an investigational new drug (IND) application to the FDA in early 2017. Pending FDA clearance, the firm intends to initiate a Phase I clinical trial at several sites, including KU Cancer Center. The goal is to enroll the first patient in a clinical trial by mid-2017.
“It takes a village to understand the biology of cancer, discover and develop new cancer treatments and demonstrate that the treatment is effective,” Weir said. “We’re proud to have built a team of experts whose strengths span the spectrum of research – from basic to translational to clinical. Because of this team effort, bladder cancer patients may soon have better treatment options.”
