• Clinical trials of Niclosamide-based oral metabolic anticancer drug to commence for patients with difficult-to-treat cancers such as triple-negative breast cancer and pancreatic cancer
• Niclosamide-based oral anticancer drug project to be carried out by the new subsidiary of Hyundai Bioscience

Hyundai Bioscience  announced the positive results from its preclinical study on triple-negative breast cancer, investigating combination therapy of 'Niclosamide-based oral anti-cancer drug' jointly developed with CNPharm and Docetaxel, one of widely-used chemical anticancer agents. As a result, the combination therapy was found to be more effective than Docetaxel alone. The anti-cancer efficacy of the combination therapy group was 67% better than the Docetaxel-treated group.

This preclinical study results will be published through an SCI-level paper.

Hyundai Bioscience has succeeded in repurposing Niclosamide as an oral anticancer drug. Niclosamide had been found effective in treating various cancers by acting on the metabolic process of cancer cells, evidenced by decades of in vitro studies.

Metabolic anticancer drugs inhibit the growth and survival of cancer cells by disrupting the unique metabolic mechanisms of cancer cells as well as blocking the cell signaling pathways. Metabolic anticancer agents exhibit higher antitumor activity when treated with the existing anticancer drugs as a combination therapy.

From the in vitro test, Niclosamide successfully inhibited the proliferation and survival of cancer cells by disrupting their metabolism, preventing the anticancer drug-resistance by blocking the cell signaling pathways of tumor cells and recurrence and metastasis of cancer by inhibiting cancer stem cells. Niclosamide is found to be an antitumor agent that blocks metabolism, and Niclosamide-based anticancer drugs can solve the resistance and metastasis problems simultaneously.

Due to its anticancer mechanism, Niclosamide is effective against multiple cancers, including lung cancer, breast cancer, prostate cancer, colon cancer, liver cancer, kidney cancer, and head and neck cancer. It has also been found to be highly effective against cancers that are resistant to current anticancer treatments such as triple-negative breast cancer, lung cancer, prostate cancer, ovarian cancer, colon cancer, pancreatic cancer, and head and neck cancer.

Although Niclosamide was known for excellent anticancer efficacy, it has not been clinically used on humans for over 60 years because of its 'low bioavailability' and 'short half-life to maintain effective drug concentration in the blood.'

Through its proprietary 'drug delivery technology' technology, Hyundai Bioscience, in collaboration with CNPharm, has developed a niclosamide-based oral anticancer drug formulation that enables a drug concentration at IC50 level or higher to inhibit the proliferation of cancer cells even with a non-toxic Niclosamide dose. Their 3-month-long in vivo toxicity tests demonstrated that the Niclosamide blood concentration level of no-observed-adverse-effect level (NOAEL) dose was 7,888 ng/mL. Considering the IC50 of various cancer cells is mostly 65~654 ng/mL, Niclosamide can effectively inhibit cancer cell proliferation even when administered at a dose less than one-tenth of the NOAEL.

Hyundai Bioscience's in vivo efficacy study on combination therapy of a niclosamide-based anticancer agent with Docetaxel was conducted on animals implanted with triple-negative breast cancer cells. The results confirmed that Niclosamide significantly increased the anticancer efficacy.

Dr. Jin Geun-Woo, leading Hyundai Bioscience R&D, highlighted the significance of these preclinical results, stating, "This is the first case that is statistically proven in vivo that the oral Niclosamide-based anticancer treatment has a remarkable effect on triple-negative breast cancer, a type of cancer that is challenging to treat. Niclosamide-based metabolic anticancer drugs could potentially address the problems of drug resistance and metastasis that make cancer treatment difficult." He added, "Clinical phase 1/2a trials will be conducted in Korea for various difficult-to-treat cancers, including triple-negative breast cancer, pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and metastatic prostate cancer."

Mr. Oh Sang-gi, the CEO of Hyundai Bioscience, announced, "The Niclosamide-based oral anticancer drug project will be carried out by a new subsidiary of Hyundai Bioscience, ADM KOREA," and added, "Hyundai Bioscience therefore plans to transfer its Niclosamide-based oral anticancer technology to its new subsidiary."