May 09, 2016
The University of Kansas Medical Center granted exclusive rights to CicloMed LLC for Ciclopirox Prodrug, a novel agent targeted for the treatment of bladder cancer. CicloMed plans to submit an investigational new drug application (IND) to the Food and Drug Administration early next year. Pending Food and Drug Administration (FDA) clearance, CicloMed intends to initiate a Phase I clinical trial at several clinical sites, including the University of Kansas Cancer Center.
"We are excited about the potential of Ciclopirox Prodrug to enhance the effectiveness of therapy for bladder cancer patients, and we are looking forward to moving this drug aggressively through development. Our goal is to enroll the first patient in a clinical trial in early 2017," said Tammy Ham, president and chief executive officer of CicloMed.
President-elect of the American Urology Association and former chair of the Department of Urology at the University of Kansas Medical Center, Brantley Thrasher, M.D., said "Novel treatments that prevent recurrence and progression of bladder cancer are desperately needed as none have been approved in the past 20 years."
Ciclopirox Prodrug was discovered by KU Medical Center's Institute for Advancing Medical Innovation (IAMI). Ciclopirox Prodrug effectively treats bladder cancer in animal models via novel mechanisms of action and selectively delivers drug to the entire urinary tract.
"The project exemplifies our vision of becoming a leading National Cancer Institute Cancer Center in discovering and advancing promising new cancer treatments to our patients," said IAMI Director Scott Weir, Pharm.D., Ph.D.
CPX-POM is the first product development and commercialization collaboration between BioNovus Innovations and IAMI under the partnership agreement recently established between the two organizations. "Our work with IAMI differentiates our National Cancer Institute-designated cancer center by allowing us to deliver treatments from bench to bedside," said Roy Jensen, M.D., director of The University of Kansas Cancer Center. "This drug has real potential to become the first KU-invented cancer drug that will span the entire process, from discovery to development, and ultimately to patients.
About Bladder Cancer Bladder cancer remains a devastating disease. In 2014, 74,690 bladder cancer patients were diagnosed with a reported 78 percent five-year survival rate. Bladder cancer is a disease of the elderly, with a mean age at diagnosis of 73 years. The American Cancer Society estimates that 16,390 bladder cancer patients will die this year. This cancer ranks as the fourth most common cancer in the U.S. for men, and the sixth most common cancer for men and women. In 2012, an estimated 577,403 patients were living with this disease. Because of the high risk of recurrence, progression and life-long surveillance, bladder cancer is the most expensive cancer to treat on a per patient lifetime basis. Despite standard of care treatment, 60-70 percent of patients with non-muscle invasive bladder cancer will recur, and 20-30 percent will progress to muscle invasive bladder cancer, where the gold standard treatment is neoadjuvant chemotherapy followed by radical cystectomy. Despite improvements in perioperative management, radical cystectomy is associated with significant morbidity with a 64 percent complication rate at 90 days. In addition, patients who progress to muscle invasive bladder cancer have worse survival than those who present with de novo muscle invasive bladder cancer.
About the University of Kansas's Institute for Advancing Medical Innovation (IAMI) Established in 2009, IAMI serves as a national model for transforming biomedical discoveries into drug, diagnostic and medical device innovations. Focusing on the creation of medical products that benefit our patients, the Institute has advanced several new drug treatments to patients through collaborations with industry, academia, government and patient advocacy partners, including The University of Kansas Cancer Center, Frontiers, Children's Mercy Hospital, the National Institutes of Health, The Leukemia and Lymphoma Society and other disease advocacy organizations. For more information, visit: kumc.edu/iami.
About BioNovus Innovations Founded by Paul DeBruce, BioNovus Innovations commercializes novel drugs, medical devices, diagnostics and other treatments from the early stages of discovery and development, through regulatory approvals, marketing and distribution to the consumer. For more information, visit BioNovus.com.