CicloMed Announces FDA Clearance of IND Application for Ciclopirox Prodrug in the Treatment of Bladder Cancer

KANSAS CITY, Mo., Oct. 11, 2017 -- CicloMed LLC announced today that its development candidate for non-muscle-invasive and muscle-invasive bladder cancer, Ciclopirox Prodrug, was cleared by the U.S. Food and Drug Administration to begin human clinical trials. With this clearance, CicloMed plans to initiate the first-in-human safety trial in patients with advanced solid tumor cancers as soon as possible at several centers, including The University of Kansas Cancer Center.

“We are excited to move Ciclopirox Prodrug into phase I trials in partnership with the KU Cancer Center and its Institute for Advancing Medical Innovation (IAMI). This drug development project demonstrates the success of our unique public-private partnership,” said Tammy Ham, president and chief executive officer of CicloMed. “Our shared goal is to discover and develop paradigm-changing cancer treatments.”

“Ciclopirox Prodrug demonstrates KU Cancer Center’s vision of bringing together basic, translational and clinical scientists to not only discover and develop new cancer treatments, but also to advance promising new treatments to patients,” said Roy A. Jensen, MD, director of the KU Cancer Center, one of only 69 cancer centers nationally designated by the National Cancer Institute (NCI). “If we are successful, our patients are the ones who will benefit.”

Discovered by a multidisciplinary team of researchers at KU Cancer Center, Ciclopirox Prodrug was licensed to CicloMed LLC, a subsidiary of Kansas City-based BioNOVUS Innovations LLC, in November 2015.

“Ciclopirox Prodrug represents the first KU Cancer Center-invented anticancer agent advancing from the laboratory to the clinical-trial participant’s bedside,” said Scott Weir, PharmD, PhD, IAMI director.

“Ciclopirox Prodrug offers hope to bladder cancer patients, who endure a lifetime of monitoring, surgical procedures and chemotherapy treatments that often are not successful,” said John Taylor III, M.D., director of basic urological research and co-leader of the Drug Discovery, Development and Experimental Therapeutics Research Program at KU Cancer Center. Dr. Taylor also is president of the Leo and Anne Albert Institute for Bladder Cancer Care and Research in New York.

Clinical Study Details

The phase l trial will evaluate the safety, dose tolerance, pharmacokinetic and pharmacodynamic properties of Ciclopirox Prodrug in patients with advanced solid tumors, including patients with metastatic bladder cancer. The dose-escalating, phase l, first-in-human trial will determine the recommended intravenous dose of Ciclopirox Prodrug for subsequent phase ll trials.

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.

About Ciclopirox Prodrug

Ciclopirox Prodrug has been developed to selectively deliver ciclopirox to the entire urinary tract following intravenous and subcutaneous administration. Ciclopirox, the active metabolite of Ciclopirox Prodrug, was first approved as a topical antifungal agent in 1982. Studies funded by CicloMed have indicated that this agent shows promise in muscle-invasive and non-muscle-invasive human bladder cancer cell lines as well as in a murine model of bladder cancer.
    
About CicloMed LLC

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.bionovus.com.

About The University of Kansas Cancer Center

The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally-accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Midwest Cancer Alliance. For more information, visit http://www.kucancercenter.org.

About the Institute for Advancing Medical Innovation

The vision of the Institute for Advancing Medical Innovation (IAMI) at The University of Kansas Cancer Center’s is to develop, demonstrate and disseminate medical innovations that change the standard of care for pediatric, adolescent and adult patients suffering from diseases including cancer and rare diseases. Its mission is to discover drugs, diagnostics and medical devices with clear paths to market. For more information, visit http://www.kumc.edu/iami.html.

For further information, contact:

CicloMed media inquiries: Dick Johnson, 913.649.8885, [email protected]
CicloMed / BioNOVUS partnering: Tammy Ham, 816.949.8721, [email protected]
KU Cancer Center media inquiries: Kay Hawes, 913.617.8698, [email protected]