- The only solution for intractable cancer caused by mutations
in the p53 gene
- Planning clinical trials targeting cancer patients with no
available treatment due to p53 gene mutations
SEOUL,
South Korea, April 25,
2024 /PRNewswire/ -- Hyundai Bioscience announced on
April 25th that its clinical
development plan of oral "Niclosamide Metabolic Anticancer Drug"
targeting cancer patients with intractable cancer caused by p53
gene mutations. Mutations in the p53 gene occur in almost all
cancer types and cause intractable cancers such cases found in
ovarian cancer, uterine cancer, esophageal cancer, etc.
The p53 gene acts as the "guardian of the genome," detecting
cellular DNA damage and inducing cell death. When mutated, the p53
gene loses its function, leading to resistance to existing
anticancer drugs and rapid metastasis of cancer cells. While
R&D attempts have been made to develop anticancer agents that
target p53 mutated cancer cells, those attempts have failed to
selectively kill p53 mutated cancer cells without damaging normal
cells.
Previous researches have shown evidences that niclosamide is a
promising metabolic anticancer agent. Niclosamide can induce cancer
cell death by regulating cancer cell metabolic pathways and can
resolve drug resistance and cancer cell metastasis while
minimizing side effects. It also enhances anticancer effects
when used in combination therapy with existing anticancer drug.
Niclosamide, however, has not been developed as an anticancer
drug for over 60 years due to its low bioavailability and short
half life. With its patented drug delivery system technology,
Hyundai Bioscience succeeded in developing niclosamide as an
oral anticancer agent by reaching the necessary drug concentration
level (IC50) to inhibit the proliferation of most cancer cells at
non-toxic (NOAEL) dose.
Recently, in a triple-negative breast cancer in vivo studies,
Hyundai Bioscience demonstrated that the combination therapy group
with oral niclosamide-based anticancer agent and docetaxel, the
widely-used chemotherapeutic drug, showed 67% higher anticancer
effects compared to the docetaxel-alone treatment group.
Long-term (13 weeks) animal toxicity tests confirmed that the blood
concentration when administering the No-observed-adverse-effect
level (NOAEL) of Niclosamide was 7,888 ng/mL. Considering that the
IC50 for most types of cancer cell is 65~654 ng/mL, niclosamide is
expected to inhibit the proliferation of most cancer cell types
even when administered at less than one-tenth of the NOAEL.
Sang-ki Oh, CEO of Hyundai Bioscience, stated,
"Niclosamide-based metabolic anticancer drug candidate will be the
first P53-targeting anticancer treatment that selectively kills p53
mutated cancer cells," and added, "Through our subsidiary ADM
Korea, we plan to conduct clinical trials targeting cancer patients
with intractable cancer caused by p53 mutations, which will be the
first step of clinical development on niclosamide-based anticancer
agent pipeline."
Jong-Eon Lim, CEO of ADM Korea,
mentioned, "We plan to submit IND for a clinical trial that is
designed to compare the combination therapy group with
niclosamide-based anticancer drug and existing anticancer drugs
treatment against the single-agent therapy group," and added, "With
this clinical trial, we will advance into a biotech specialized in
oral metabolic anticancer agent."
About Hyundai Bioscience
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 Hyundai Bioscience