ADM Korea Announces First Clinical Trial of Niclosamide-based Anticancer Drug for Hormone Therapy-Resistant Prostate Cancer Patients

ADM Korea, a subsidiary of Hyundai Bioscience, announced plans to target 'prostate cancer patients resistant to hormone therapy' in its first clinical trial for a niclosamide-based oral metabolic anticancer drug. This novel drug aims to regulate metabolic pathways in cancer cells, inducing their death and blocking the signaling pathways that contribute to drug resistance.

Existing anticancer treatments, including hormone therapies, chemotherapies, targeted therapies, and immunotherapies, often fail due to the development of drug resistance in cancer cells. This resistance occurs when cancer cells activate certain signaling pathways to evade the effects of anticancer agents. Addressing this problem has been a significant challenge, as no drug has yet been developed to effectively combat drug resistance in cancer cells.

Niclosamide, a drug known to inhibit the Wnt/β-catenin and STAT3 signaling pathways, has shown potential in this regard. These pathways are typically activated when cancer cells develop resistance to anticancer drugs. Studies indicate that niclosamide, when combined with chemotherapies (like SN38 and azacitidine), immunotherapies (PD-L1 Ab), targeted therapies (erlotinib), and hormone therapies (enzalutamide), offers superior anticancer effects compared to single-agent treatments. However, niclosamide has historically faced challenges like low absorption and short half-life, preventing its repurposing as an anticancer drug.

CNPharm, poised to enter an exclusive license agreement with ADM Korea, has overcome these challenges using patented technology, successfully repurposing niclosamide as an oral metabolic anticancer drug. In animal studies focused on triple-negative breast cancer, the combination of docetaxel and the niclosamide-based drug showed a 67% improvement in anticancer effects compared to docetaxel alone. Further, a three-month animal toxicity study revealed that the drug's blood concentration at the NOAEL (No Observable Adverse Effect Level) was 7,888 ng/mL, with cancer cell proliferation reduced by 50% at concentrations much lower than the NOAEL level (65~654 ng/mL), confirming the drug's safety. The oral niclosamide-based drug is convenient and easy to administer.

ADM Korea is preparing to conduct clinical trials that combine existing treatments with the niclosamide-based metabolic anticancer drug for terminal cancer patients resistant to current medications. The company plans to submit an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety of the Republic of Korea in August for a clinical study involving hormone therapy and the niclosamide-based drug in hormone-resistant prostate cancer patients. This decision was influenced by a proposal from a domestic prostate cancer expert and factors such as the rising number of prostate cancer patients, the lack of suitable treatments for hormone-resistant cases, the relatively shorter clinical trial period for prostate cancer (about four weeks), and expected higher therapeutic effects.

A recent Lancet paper projects that the global number of prostate cancer patients will more than double from 1.4 million in 2020 to 2.9 million by 2040, with the global prostate cancer market expected to reach approximately 29.8 trillion KRW by 2025. Combining niclosamide with existing anticancer treatments is anticipated to solve the issue of drug resistance, significantly enhancing the effectiveness of anticancer therapy compared to single-agent treatments and dramatically improving the quality of life for cancer patients.

Jin Geun-woo, Vice President of ADM Korea, emphasized that the clinical trial aims to verify the safety and efficacy of combining the niclosamide-based metabolic anticancer drug with hormone therapy in prostate cancer patients by observing PSA levels over four weeks. Previous studies have shown that in animal models, the combination of niclosamide and enzalutamide led to a significant tumor reduction, marking a potential turning point in prostate cancer treatment.