- IND for clinical study for combination therapy with hormone
therapy in prostate cancer patients to be submitted in August,
2024.
- Niclosamide-based metabolic anticancer drug aims to block
signaling pathways that allow cancer cells to evade anticancer
effects, potentially solving the issue of drug resistance.
SEOUL,
South Korea, July 11,
2024 /PRNewswire/ -- ADM Korea, a subsidiary of
Hyundai Bioscience, announced on the 8th that the first clinical
trial target population for its niclosamide-based oral metabolic
anticancer drug will be 'prostate cancer patients resistant to
hormone therapy.'
Metabolic anticancer drugs regulate the metabolic pathways of
cancer cells to induce their death. The niclosamide-based metabolic
anticancer drug not only regulates the metabolic pathways of cancer
cells to induce their death but also blocks the signaling pathways
of cancer cells that avoid anticancer effects, thus inhibiting drug
resistance.
Currently used anticancer drugs, including hormone therapies,
chemotherapies, targeted therapies, and immunotherapies, all fail
to resolve the issue of cancer cell drug resistance that arises
with long-term treatment. Cancer cell resistance refers to the
phenomenon where cancer cells activate cell signaling pathways that
help them evade the effects of anticancer agents through repeated
drug administration, thereby decreasing the efficacy of the drugs.
The biggest challenge in anti-cancer treatment is solving the
problem of cancer cell drug resistance, but no drug has yet been
developed to address this.
Niclosamide is a drug that has been identified to inhibit the
Wnt/β-catenin and STAT3 cell signaling pathways, which are
activated when cancer cells develop resistance to anticancer drugs,
thereby suppressing cancer cell drug resistance. Numerous studies
have shown that when niclosamide is used in combination with
chemotherapies (such as SN38 and azacitidine), immunotherapies
(PD-L1 Ab), targeted therapies (erlotinib), and hormone therapies
(enzalutamide), the anticancer effects are superior to those of
single-agent treatments. However, due to the longstanding issues of
low absorption and short half-life, niclosamide has not been
repurposed as an anticancer drug over the past 60 years.
CNPharm, which plans to enter into an exclusive license
agreement with ADM Korea, has overcome these two issues with its
patented technology, successfully repurposing niclosamide as an
oral metabolic anticancer drug.
In a triple-negative breast cancer model animal study conducted
by CNPharm, the combination treatment of the chemotherapeutic agent
docetaxel and the niclosamide-based metabolic anticancer drug
showed 67% greater anticancer effects compared to the
docetaxel-only treatment group. Additionally, in a three-month
animal toxicity study of the oral niclosamide-based metabolic
anticancer drug, the blood concentration at the NOAEL (No
Observable Adverse Effect Level) of niclosamide was 7,888 ng/mL,
and cancer cell proliferation was found to be reduced by 50% at a
concentration of less than one-tenth of NOAEL level (65~654 ng/mL)
in in vitro study, confirming the drug's safety. The
niclosamide-based drug is an oral medication offering convenience
and ease of administration.
ADM Korea plans to conduct clinical trials combining existing
treatments with the oral niclosamide-based metabolic anticancer
drug for all terminal cancer patients who have developed resistance
to existing anticancer drugs. Initially, in August, ADM Korea will
submit an IND to the Ministry of Food and Drug Safety of the
Republic of Korea for a clinical study combining hormone therapy
and the niclosamide-based metabolic anticancer drug in prostate
cancer patients resistant to hormone therapy. ADM Korea received a
proposal for this combination therapy clinical study from a
domestic prostate cancer expert in mid-May. ADM Korea decided to
conduct the clinical trial on prostate cancer patients first, as
the number of prostate cancer patients is steadily increasing,
there is no suitable treatment for patients resistant to hormone
therapy, the clinical trial period for prostate cancer is
relatively shorter (taking about four weeks), and higher
therapeutic effects compared to other cancers can be expected.
According to a recent paper published in the Lancet, the number
of prostate cancer patients worldwide is expected to more than
double from 1.4 million in 2020 to 2.9 million in 2040. The global
prostate cancer market is predicted to reach approximately
29.8 trillion KRW by 2025.
Combining niclosamide with existing anticancer treatments is
expected to solve the problem of drug resistance, significantly
enhancing the effectiveness of anticancer therapy compared to
single-agent treatments, and drastically improving the quality of
life for cancer patients.
Vice President of ADM Korea Jin Geun-woo said, "The clinical
trial is designed to verify the safety and efficacy of combining
niclosamide-based metabolic anticancer drug and hormone therapy in
prostate cancer patients over four weeks by observing PSA levels.
According to Clinical Cancer Research article {20.12 (2014)}, in
animal models with tumors resistant to secondary hormone therapies
for prostate cancer, enzalutamide alone reduced tumors by only
about 5%, while the combination of niclosamide and enzalutamide
resulted in a tumor reduction of about 72%. The niclosamide-based
metabolic anticancer drug will mark a historic turning point in
prostate cancer treatment."
About ADM Korea Inc. and Hyundai Bioscience
ADM Korea Inc., a subsidiary of Hyundai Bioscience, is a
biotechnology company that develops anticancer drugs and also a
Clinical Research Organization (CRO) service company in
South Korea. ADM Korea Inc. is
listed on the KOSDAQ market (symbol: 187660).
Hyundai Bioscience is a biotechnology company that
develops new drugs based on its novel drug delivery system
technologies to deliver active ingredients safely and efficiently
to targeted areas of the human body. Founded in 2000, Hyundai
Bioscience focuses on repurposing or expanding indications of
existing drugs using its proprietary organic-inorganic hybrid
technologies. Hyundai Bioscience is a public company listed on
KOSDAQ (symbol: 048410) in South
Korea.
For more information, please contact Ms. Joobin Jung, Global PR Manager
(joobin@hyundaibio.com).
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SOURCE ADM Korea