CicloMed Announces Initiation of Phase 1B Trial of

KANSAS CITY, Mo., June 29, 2021 (GLOBE NEWSWIRE) — CicloMed LLC., a Kansas City-based biotechnology company developing novel treatments for bladder cancer and other malignancies, today announced that the Phase 1B clinical trial of fosciclopirox for the treatment of bladder cancer is now open.

“We are pleased to have initiated this phase 1B study of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors,” said Tammy Ham, CEO of CicloMed. “We believe that fosciclopirox has strong potential to improve treatment outcomes for patients with bladder cancer.”

In September 2020, CicloMed received a Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI), enabling the Phase 1B trial. “The SBIR grant validates our work developing fosciclopirox for the treatment of bladder cancer,” said Ham. “When an external panel of scientists positively confirms your work, you know you’re on the right track.”

The Phase 1B study is being conducted at the University of Kansas Cancer Center under the direction of John A. Taylor III, MD, M.Sc., director of Urologic Research and co-leader of the Drug Discovery, Delivery and Experimental Therapeutics Research Program and founder and director of the Leo and Anne Albert Institute for Bladder Cancer Care and Research.

“In addition to supporting the Phase 1B trial, the NCI SBIR grant allows us to study the relationships between targets modulated by fosciclopirox and treatment outcomes in patients receiving standard of care,” Taylor said. “We are reviewing our registry of bladder cancer patients and our biorepository consisting of more than 1,000 bladder tumor specimens from approximately 500 patients to identify patients who are more likely to benefit from fosciclopirox treatment.”

“Fosciclopirox inhibits bladder cancer initiation and progression in preclinical models, at least in part, by acting as a gamma secretase complex inhibitor, resulting in inhibition of Notch and Wnt signaling pathways,” said Scott Weir, director of the Institute for Advancing. Medical Innovation at the University of Kansas Medical Center and CicloMed Acting Chief Scientific Officer. “Working with Dr. Taylor will allow us to explore the relationships between Notch and Wnt signaling and response to immunotherapy and chemotherapy. The start of this Phase 1B study allows us to explore the pharmacological activity and mechanisms of action of fosciclopirox after treatment in urothelial cancer patients,” Weir added.

CicloMed presented results of its completed fosciclopirox first-in-human phase 1 dose-escalation study in patients with advanced solid tumors (NCT03348514) at ASCO-GU 2020. In addition, the company announced at the time that it had opened a phase 1 expansion cohort study (NCT04608045) at three US sites evaluating fosciclopirox in a neoadjuvant setting in muscle-invasive bladder cancer patients scheduled for cystectomy. The Phase 1 expansion cohort study is expected to complete enrollment in September 2021.

Visit www.ciclomed.com and www.bionovus.com For more information.

Research reported in this release is supported by the National Cancer Institute of the National Institutes of Health under Grant Number 1R44CA246997-01A1. The content is the sole responsibility of CicloMed and does not necessarily represent the official views of the National Institutes of Health.

About Fosciclopirox

Fosciclopirox was discovered by scientists at the NCI-designated Cancer Center headquartered at the University of Kansas Medical Center, and the Institute for Advancing Medical Innovation (IAMI), the cancer center’s product development company. CicloMed was established in 2016 as a public-private partnership between BioNovus Innovations LLC and IAMI, with fosciclopirox as the lead drug development candidate.

About bladder cancer

More than 500,000 men and women are living with bladder cancer in the United States. Bladder cancer is the seventh most common cancer in Americans and the fourth most common cancer in men. According to the American Cancer Society, approximately 81,400 new cases of bladder cancer will be diagnosed this year and 17,980 deaths are expected from the disease. Of all known malignancies, bladder cancer has the highest recurrence rate, and bladder cancer also has the highest lifetime treatment cost per patient of all cancers.

About CicloMed LLC

CicloMed is a developmental pharmaceutical company focused on unmet medical needs in oncology, and fosciclopirox (formerly Ciclopirox Prodrug, CPX-POM) is the lead drug development candidate. CicloMed is a portfolio company of BioNovus Innovations LLC, a unique company created to invest in individuals and organizations that are transforming healthcare. BioNovus is breaking new ground with the financial investment and commitment to make new solutions a reality.

About the University of Kansas Kansas Cancer Center

The University of Kansas Cancer Center is transforming cancer research and clinical care by combining an innovative approach to drug discovery, delivery and development with a nationally recognized patient care program. Our consortium center includes cancer researchers and healthcare professionals involved in the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Laurens; The Stowers Institute for Medical Research; Mercy for Children; and in collaboration with members of the Masonic Cancer Alliance.

About the Institute for Advancing Medical Innovation

The vision of the Institute for Advancing Medical Innovation (IAMI) at the University of Kansas Cancer Center 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 medicines, diagnostics and medical devices with clear paths to the market. For more information visit www.kumc.edu/iami.html.

For further information contact:
Gina Meagher
gemagher@gmail.com

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