- Polytaxel, a novel pain-free anticancer drug, may not
require break periods
- A new standard of care, more convenient than docetaxel, is
- Hyundai Bioscience to enter clinical trial on pancreatic cancer
- Patient-centered chemotherapy to enable outpatients to live
SEOUL, South Korea,
Nov. 25, 2022 /PRNewswire/ -- An
innovative anticancer therapy that may complete chemotherapy with
two doses of an anticancer drug in as short as 8 days is to enter a
clinical trial for cancer patients.
This chemotherapy is a patient-centered treatment that focuses
on controlling toxicity of anticancer drug. This unprecedented
chemotherapy is expected to help cancer patients receive outpatient
treatments without suffering from side effects and live their
normal lives at home and at work.
Hyundai Bioscience announced on November
24th, 2022, that it is collaborating with an Australian
cancer hospital for its global Phase 1 clinical trial on pancreatic
cancer with Polytaxel, which was developed as so-called 'pain-free'
anticancer drug, based on a novel inorganic polymer
nanohybrid drug delivery platform technology. Polytaxel is
loaded with docetaxel as its active pharmaceutical ingredient,
which is known as one of the major chemotherapy drugs. Hyundai
Bioscience will file its clinical plan to the Human Research Ethics
Commission (HREC) of Australia as
soon as its clinical design is confirmed with a local clinical
Hyundai Bioscience held a press conference at Ewha Womans
University on November 22nd, and
unveiled its clinical trial design of Polytaxel along with NOAEL
therapy, an innovative cancer therapy that may be administered
without recovery break periods.
"The clinical design of Polytaxel has a very unique dosing
method compared to the existing standard treatment method of
docetaxel," said Park Kwang-Sik, president of Hyundai Bioscience's
Bio Division. He said, "Based on the very low toxicity of
Polytaxel, a completely new standard treatment to enable pain-free
anticancer treatment has emerged."
Hyundai Bioscience's clinical trial design is basically to
administer Polytaxel by 7-day interval to two separate groups of
patients, twice for one cohort and three times for the other. For
the two-dose group, it will take 8 days to complete administration,
and 15 days for the three-dose group. Existing chemotherapy with
docetaxel usually takes 3~6 months due to the fact that there needs
to be a 3-week recovery period between doses.
It is remarkable that such dosing frequency of 7-day interval is
the same as was applied to animal testing. In case of conventional
chemotherapy, the patients must have a recovery period after drug
injection due to severe side effects caused by the drug's toxicity.
That's why the dosing interval from efficacy testing on animals is
not equally adopted to human testing typically.
Mr. Park said, "Polytaxel showed excellent therapeutic efficacy
in remission of tumors by 67% up to 83% with just three doses on
days 1, 8, and 15 in pre-clinical trials. Nevertheless, there was
no decrease at all in body weight, the most important indicator of
Dr. Jin Geun-Woo, head of Hyundai
Bioscience R&D, said, "Cytotoxic drug-based chemotherapy has
not made significant progress for several decades because the
dosing interval applied to animals cannot be applied directly to
humans due to drug toxicity." He explained, "It is inevitable for
humans to have a recovery period for a period of time so that
normal cells damaged by drug toxicity can recover after the
previous dose, and the problem is that cancer cells also recover
during such recovery period."
Dr. Jin said, "We have conducted dozens of animal testing with
the goal of applying the same dosing interval to animals and
humans, and we have finally found the appropriate dosing interval
to satisfy it." He said, "Polytaxel is a safe drug that is
effective even if administered below the non-toxic level, which
enables the same dosing interval to be applied for both humans and
Pancreatic cancer is known as one of the hardest-to-cure kinds
with the lowest survival rate among the top 10 cancers, with a
5-year survival rate of 7.9% and a 10-year survival rate of only
1%, because early diagnosis is almost impossible and drug delivery
is structurally difficult. In the last 20 years since 2003, 174
candidates have been designated as orphan drugs for the treatment
of pancreatic cancer by the U.S. Food and Drug Administration
(FDA), but only three have actually been approved.
Mr. Park explained, "The decision to select pancreatic cancer as
the clinical target indication for Polytaxel is part of our
strategy to accelerate the approval process through fast track by
proving the safety and efficacy of Polytaxel in the most
intractable cancer." He said, "In the pharmacokinetics study we
conducted at Japan's Sekisui
Medical, Polytaxel, although it is a polymer substance, was
verified to be well delivered to the pancreas, which has been known
to be hard to reach in drug delivery."
Lee Hwa-Jeong, professor of
pharmacy at Ewha Womans University, who participated as a panelist
at the conference, said, "It is very impressive that Polytaxel
achieved a concentration in tumors 10 times higher than that in
normal tissue at preclinical study, proving great tumor-targeting
property." Peter Koo, former Yale
University Medical School professor, said, "It will be a positive
thing, if Polytaxel gets successfully approved, that we will have
more combination anticancer treatment options." Mr. Koo also
recommended a continuing research to be conducted on the use of
immuno-oncology drugs in combination.
Hyundai Bioscience has performed rigorous R&D efforts to
establish the formulation of Polytaxel suitable for mass production
or CMC (chemistry, manufacturing and controls), and finally
completed its NOAEL therapy, a pain-free chemotherapy. NOAEL
therapy is a novel therapy in that Polytaxel is administered below
no-observed-adverse-effect level (NOAEL) in vivo, so that cancer
may be treated without side effects. Hyundai Bioscience had
previously announced the feasibility of this at the Global Bio
Conference (GBC) held in Seoul in
2018 and 2019.
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