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First Patient Dosed with Ciclopirox Prodrug in Phase I Trial in Patients with Advanced Solid Tumors

March 01, 2018

CicloMed LLC, a biotechnology company developing novel treatments for bladder cancer, announced that the first patient has been dosed in a Phase I clinical trial.

The anti-cancer drug, called Ciclopirox Prodrug, or CPX-POM, was discovered at The University of Kansas Cancer Center. The study is characterizing the safety, dose tolerance, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors.

The first-in-human trial will enroll patients at several U.S. 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.

In a unique public-private partnership with CicloMed LLC, a subsidiary of BioNovus Innovations LLC, KU’s Institute for Advancing Medical Innovation (IAMI) and KU Cancer Center completed studies required by the Food and Drug Administration to obtain clearance to advance the drug to patients. This is the first drug development collaboration advanced to patients by the public-private 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, M.D., director of The University of Kansas Cancer Center.

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About Bladder Cancer

More than 500,000 men and women are living with bladder cancer in the United States. 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.

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