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Hyundai Bioscience Reveals Clinical Strategy for Niclosamide-Based Metabolic Anticancer Treatment Aimed at P53 Mutation-Associated Cancer

Friday, April 26, 2024

Hyundai Bioscience made headlines on April 25th with its breakthrough announcement regarding the development of an oral anticancer drug targeting patients with intractable cancers caused by p53 gene mutations. These mutations are pervasive across various cancer types such as ovarian, uterine, and esophageal cancer.

The p53 gene plays a crucial role as the "guardian of the genome," detecting DNA damage within cells and triggering cell death mechanisms. However, when mutated, it loses this function, resulting in resistance to conventional anticancer treatments and aggressive metastasis of cancer cells. Despite previous efforts to develop drugs targeting p53 mutations, none have been successful in selectively killing mutated cancer cells without harming healthy ones.

Previous research has identified niclosamide as a promising metabolic anticancer agent. It operates by modulating cancer cell metabolic pathways, inducing cancer cell death, overcoming drug resistance, and inhibiting cancer cell metastasis, all while minimizing side effects. Additionally, niclosamide demonstrates enhanced anticancer effects when used in combination with existing therapies.

However, the development of niclosamide as an anticancer drug has been hindered for over six decades due to its poor bioavailability and short half-life. Through innovative patented drug delivery technology, Hyundai Bioscience has succeeded in formulating niclosamide into an oral anticancer agent, achieving the necessary drug concentration levels to inhibit cancer cell proliferation at non-toxic doses.

Recent in vivo studies conducted on triple-negative breast cancer models showcased the potential of combination therapy involving Hyundai Bioscience's oral niclosamide-based anticancer agent and docetaxel, a widely used chemotherapeutic drug. The combination therapy demonstrated a 67% increase in anticancer effects compared to docetaxel treatment alone. Furthermore, long-term animal toxicity tests confirmed the safety of niclosamide, even at concentrations below one-tenth of the No-Observed-Adverse-Effect Level (NOAEL), with a blood concentration of 7,888 ng/mL, well above the IC50 required to inhibit most cancer cell types.

CEO Sang-ki Oh expressed confidence in their niclosamide-based metabolic anticancer drug candidate, heralding it as the first treatment to selectively target and eliminate p53 mutated cancer cells. He announced plans to initiate clinical trials targeting patients with intractable cancers caused by p53 mutations through their subsidiary, ADM Korea, marking the initial phase of clinical development for the niclosamide-based anticancer agent pipeline.

Jong-Eon Lim, CEO of ADM Korea, outlined their strategy to submit an Investigational New Drug (IND) application for a clinical trial comparing combination therapy with niclosamide-based anticancer drugs and existing treatments against single-agent therapy. This milestone, he noted, will propel them toward becoming a leading biotech specializing in oral metabolic anticancer agents.



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