ADM Korea Launches First Clinical Trial of Niclosamide-Based Anticancer Drug for Prostate Cancer

ADM Korea Launches First Clinical Trial of Niclosamide-Based Anticancer Drug for Prostate Cancer

ADM Korea Launches First Clinical Trial of Niclosamide-Based Anticancer Drug for Prostate Cancer Patients Resistant to Hormone Therapy

Overview

ADM Korea, a subsidiary of Hyundai Bioscience, has announced plans to initiate clinical trials for their niclosamide-based oral metabolic anticancer drug, targeting prostate cancer patients resistant to hormone therapy. This novel drug aims to tackle cancer cell drug resistance by not only regulating cancer cell metabolic pathways to induce cell death but also by blocking signaling pathways that cancer cells use to evade treatment effects.

Drug Resistance

  • Current anticancer treatments such as hormone therapies, chemotherapies, targeted therapies, and immunotherapies often become ineffective due to cancer cell drug resistance. 
  • Niclosamide, identified for its ability to inhibit the Wnt/β-catenin and STAT3 pathways linked to drug resistance, has shown promising anticancer effects in combination therapies with various agents. 
  • However, its historical challenges with absorption and half-life have hindered its use in cancer treatment until now.

CNPharm’s New Technology

  • CNPharm has developed patented technology to address these challenges, allowing niclosamide to be repurposed effectively as an oral anticancer drug. 
  • Animal studies have demonstrated significant anticancer effects when combined with chemotherapy, such as docetaxel, showing a 67% improvement over chemotherapy alone in triple-negative breast cancer models. 
  • Furthermore, safety studies have indicated a wide safety margin, with significant reductions in cancer cell proliferation even at low concentrations well below the observed safe levels in animal toxicity studies.

IND by ADM Korea

  • ADM Korea plans to submit an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety in August, beginning with clinical trials combining niclosamide with hormone therapy for prostate cancer patients resistant to conventional treatments. 
  • The decision to prioritize prostate cancer stems from its increasing prevalence and the urgent need for effective therapies for hormone-resistant cases. 
  • Initial clinical trials are expected to be relatively short, about four weeks, with potential for high therapeutic efficacy compared to other cancers.

Global Market for Prostate Cancer Treatment

  • The global market for prostate cancer treatment is projected to grow substantially, highlighting the potential impact of ADM Korea's niclosamide-based drug in enhancing treatment outcomes and quality of life for cancer patients. 
  • Vice President Jin Geun-woo expressed optimism about the drug's potential, citing significant tumor reduction observed in preclinical models resistant to hormone therapies.
  • This initiative marks a significant advancement in prostate cancer treatment, aiming to overcome drug resistance and improve patient outcomes through innovative therapeutic approaches.

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