- "Successful disappearance of tumors in subjects upon
administering the pain-free anticancer drug, Polytaxel, without
side effects such as weight loss."
- Suppressed 99.8% of tumors despite a non-toxic dose…more
effective than existing FDA-approved pancreatic cancer drugs.
- Hopes for a Korean 'Anti-cancer Drug' amidst chemotherapy's 70
year history.
SEOUL, South Korea,
June 30, 2020 /PRNewswire/ -- There
has been an increase in the possibility for the 'conquering of
cancer' as test results confirm, for the first time, the
disappearance of tumors upon administering a 'pain-free anticancer
drug.'
On June 30th, Hyundai
Bioscience (CEO, Oh Sang-Ki/ KOSDAQ: 048410) announced that its
majority Shareholder, CNPharm, had conducted animal testing at a
non-clinical CRO agency to compare the efficacy of Polytaxel,
developed as a new pain-free anticancer drug, to Nab-paclitaxel. As
a result of administering 20mg/kg, which is a dose within the
maximum non-toxic 'No Observed Adverse Effect Level (NOAEL),' to
Polytaxel group animals, it was confirmed that the tumor nearly
disappeared upon observation of the tumor's height decreased and
flattened in two thirds of the animals.
Among a total of 48 animals tested in this study, particularly
one of the four animals, out of the six animal groups of Polytaxel
administration, showed that the tumor had disappeared completely,
while the tumors of three others showing to have nearly
disappeared. CNPharm continues to observe changes in the tumors of
the remaining three animals. In addition to the four animals, two
animals are being involved in a follow-up experiment to remove the
tumors, such as administering one or two additional doses.
Hyundai Bioscience administered Polytaxel within NOAEL, which is
undergoing clinical procedures for the treatment of pancreatic
cancer, and has been proven to have higher safety and efficacy than
Nab-paclitaxel, a pancreatic cancer treatment approved by the
FDA.
As a result of the study, a Polytaxel dose within NOAEL of 20
mg/kg that was administered inhibited tumor growth in the body by
99.8% without the side effect of weight loss to the subject caused
by drug toxicity. On the other hand, even though a Nab-paclitaxel
dose of 30mg/kg, 30 times greater than NOAEL, was administered,
only 41.4% of tumor growth inhibition was observed. Nab-paclitaxel
is currently widely used as a pancreatic cancer treatment.
Additionally, the body weight of the Nab-paclitaxel-administered
subject was reduced by 0.9%, which shows that the subject was not
free from toxicity.
In the results of animal experiments of pancreatic cancer
published at the Global Bio Conference (GBC) last year, a dose
within NOAEL of Polytaxel has proved that it is safer and more
effective than Docetaxel, a candidate for pancreatic cancer
treatment. There have been no cases where existing chemotherapy
drugs such as Nab-paclitaxel or Docetaxel showed efficacy in animal
experiments when dosed within NOAEL.
CNPharm's use of 'pain-free anticancer therapy' (NOAEL Therapy),
which can cure cancer without causing side effects due to drug
toxicity by administering 'ultra-low-toxicity' doses of anticancer
drugs within NOAEL, was first unveiled at the GBC hosted by the
Korean Government in June, 2019 and attracted much international
attention.
When the results of this experiment are confirmed in human
clinical trials, cancer patients can cure cancer with painless
chemotherapy without suffering side effects from drug toxicity due
to surgery or radiation therapy. In this case, this form of
treatment is expected to replace standard chemotherapy which
appeared on the medical scene in the 1950's and has been widely
used thus far.
Existing anticancer therapies administer toxic drugs at levels
far higher than NOAEL, and patients are in need of a recovery
period after the drugs are administered. They have a limitation in
that they extend the patient's life by reducing the size of the
tumor rather than curing the cancer. On the other hand, this new
pain-free anticancer therapy cures cancer without side effects by
continuously attacking only the tumor cells while the drug
administered within the NOAEL dosage stays in the body for a long
time for long circulation.
An official from Hyundai Bio said, "Once this pain-free
anticancer therapy is put into practice, patients will not only be
relieved from side effects caused by drug toxicity, but also will
not need surgery or radiation treatment."
On the heels of the Polytaxel research, CNPharm is currently
conducting a related experiment by designating 'Polyplatin', a
platinum-based anticancer drug, as a new pain-free drug.
CNPharm plans to expand the range of diseases that can be
treated with pain-free anticancer drugs, such as Polytaxel and
Polyplatin, using its platform-based technology to treat various
cancers as well as viral diseases.
For more information, please
visit: www.hyundaibioscience.com
-END-
Q&A
Question: What is the most important point in this
animal test comparing the efficacies on pancreatic cancer?
Answer: It was confirmed that the tumor was
completely removed in an efficacy comparison experiment on an
intractable cancer, pancreatic cancer. It is also the first case
that a tumor disappeared completely by administering an anticancer
drug within the maximum non-toxic limit (NOAEL) that doesn't cause
side effects due to toxicity. This proves that cancer can be cured
by administering anticancer drugs at a dose that does not develop
drug toxicity. In other words, it can be summarized that conquering
cancer without bodily harm has been proven to no longer be a dream.
If universalization of this is achieved through clinical trials,
cancer patients can be cured by continuing administration of
non-toxic anticancer drugs without the need for surgery or
radiation therapy. In the course of chemotherapy, it means that
patients can live a normal life while maintaining a certain level
of health.
Question: At last year's GBC, CNPharm announced the
results that Polytaxel can eliminate tumors within NOAEL. What is
difference regarding these latest experiments?
Answer: The experiment published at last year's GBC
confirmed that the pain-free anticancer drug, Polytaxel, is
effective in treating pancreatic cancer. The drug to be compared
was Docetaxel, which has not yet been approved as a treatment for
pancreatic cancer by the FDA. As a result of the experiments
conducted from December 2018 to March
of the following year, it was proven that Polytaxel is more
effective than Docetaxel in treating pancreatic cancer without side
effects caused by toxicity. At the same time, tumors nearly
disappeared in some of the subjects administered with Polytaxel,
but the pattern was relatively less pronounced in the results of
this experiment. Complete death was not observed.
This experiment was conducted to confirm whether Polytaxel can
completely remove tumors within NOAEL. As a result of the
experiment, tumors disappeared in four out of six subjects, and in
one of them, the complete elimination of the tumor was confirmed
for the first time. Therefore, a follow-up experiment is underway
to confirm the results of the complete cancer treatment in all six
subjects of the experimental group.
An efficacy comparison experiment was conducted against
Nab-paclitaxel, a pancreatic cancer drug currently on the market
that is approved by the FDA. As a result of the experiment,
Polytaxel administered within NOAEL did not cause side effects and
showed better efficacy than Nab-paclitaxel, which was administered
at 30 times higher than NOAEL. This is a preclinical result;
however it proves that Polytaxel can be a next-generation
anticancer drug that is superior to the existing pancreatic cancer
treatments in terms of ability to control toxicity and its
efficacy.
Question: How would you best portray pain-free
therapy (NOAEL)?
Answer: NOAEL therapy, a painless anti-cancer
therapy, liberates the patient from the toxicity of the drug by
administering it in a pain-free dosage that shows efficacy in
curing cancer, even when the dose is within the maximum non-toxic
limit and the drug's toxicity is not apparent in the body. This is
a next-generation patient-friendly form of chemotherapy. It can be
said that this is the emergence of a 'new standard therapy,' which
can simultaneously replace chemotherapy and radiation therapy.
Patients do not suffer from side effects due to drug toxicity
because such an ultra-low toxicity dose is administered causing
little to no discomfort from side effects. Since there are no side
effects due to drug toxicity, it is possible to continuously
administer the drug until the tumor disappears completely without a
recovery period to overcome side effects. NOAEL therapy is treating
cancer until it is completely cured, with safe drugs that do not
harm the patient's health.
Question: What makes pain-free chemotherapy
different from conventional chemotherapy?
Answer: The standard treatment of chemotherapy
generally attacks cancer cells, causes gene damage or interferes
with gene replication. However, it is known that fully curing
cancer cells is almost impossible theoretically. For this reason,
this form is designed to attack as many cancer cells as possible by
administering a dose within the range that the human body can
withstand the side effects of drug toxicity. This is why the dosage
far exceeds NOAEL. As a result, highly toxic anticancer drugs
attack even normal cells, seriously damaging the patient's health
in the course of chemotherapy. Therefore, in currently existing
anti-cancer therapies, a recovery period of about 2 to 4 weeks is
usually expected so that normal cells can recover.
Another purpose of chemotherapy is the reduction of tumors to
extend the patients' life rather than complete regression of
cancer. It is almost impossible to cure cancer with existing
anti-cancer therapies, especially for metastatic and resistant
cancers.
Existing anti-cancer drugs are administered to patients with a
recovery period in mind because the strong toxicity attacks normal
cells as well. Resistant cancers have been pointed out as a common
limitation of existing anticancer therapies along with the
development of metastatic cancer.
Moreover, in the existing anticancer therapy, surgery or
radiation therapy is combined with the administration of anticancer
drugs. Due to this, patients suffer from various concurrent
treatment side effects in addition to the side effects due to drug
toxicity. It is a reality that many patients treated with
conventional anticancer therapies have lost their health or
suffered unfortunate deaths due to side effects of the drugs and/or
concurrent treatments. Unlike conventional therapies, CNPharm's
pain-free anticancer therapy has a mechanism to cure cancer within
a non-toxic dosage. One of its great features is that it does not
require a combination of surgery or radiation therapy, but only
drug administration. When treated with this pain-free therapy,
there are no side effects due to drug toxicity and the patient does
not suffer from side effects due to surgery or radiation
treatment.
Drugs used in this pain-free therapy also apply a new concept of
a 'targeted anticancer drug', such as Polytaxel, which circulates
in the body for a long time and exerts efficacy only on cancer
cells, continuously attacking cancer cells without a rest or
recovery period. The hope to cure cancer is no longer a dream if it
is administered continuously.
Question: What about 'Metronomic Chemotherapy',
treating cancer by repeatedly administering the lowest dose of an
anticancer drug so that the toxic expression can be suppressed as
much as possible?
Answer: Metronome anticancer therapy is a new form
of therapy that continuously administers the lowest dose of an
anticancer drug so that the toxicity of the drug does not affect
the human body. Like a metronome that determines the speed of
music, this is an anticancer therapy that periodically administers
the lowest dose of anticancer drugs, which are often very toxic and
ineffective.
Unlike conventional chemotherapy, where toxic drugs attack
cancer cells directly, this form of therapy indirectly prevents the
growth of cancer cells by suppressing angiogenesis which is
necessary for tumor growth. If conventional anti-cancer therapy
wields a strong punch against tumors, the metronome therapy can be
compared to a jab.
This is a therapy that first appeared in the early 1990's so
there are not many papers related to it and cannot be treated with
existing anticancer therapies. There is a limitation for patients
with very weak bodies, such as the elderly. In addition, there is a
problem in that if a low-dose drug is continuously administered,
drug resistance is expressed in cancer cells and side effects due
to accumulation of toxicity appear in the body. It is also pointed
out that this form of treatment is insignificant for
carcinomas.
As mentioned above, metronome chemotherapy can be said to be a
treatment that supports existing chemotherapies, the standard
treatment for cancer. In this regard, it is a sub-therapy that
cannot be compared with the pain-free anticancer therapy of
CNPharm, which continuously administers safe anticancer drugs
controlled by advanced technology until the cancer cells die.
Pain-free chemotherapy, which directly attacks only cancer cells,
can theoretically prevent resistant cancers and treat metastatic
cancer as well.
Question: What are the future plans for pain-free
anticancer therapy?
Answer: CNPharm's pain-free anticancer therapy
constitutes a safe drug that does not express toxicity in the body
and aims to cure all cancers. This not only relieves the patient's
pain caused by drug toxicity, but also eliminates the need for
surgery or radiation therapy that has many side effects. CNPharm is
in the process of developing Polytaxel as a new pain-free
anticancer drug to treat pancreatic cancer in the U.S. and abroad.
CNPharm plans to carry out an IND filing this year in cooperation
with its affiliated company Hyundai Bioscience for the global
clinical trials of Polytaxel.
Polytaxel is a modified new drug loaded with Docetaxel. The main
difference between it and Docetaxel is that it is effective within
NOAEL and does not exhibit toxicity. Since it stays in the body for
a long circulation and attacks only cancer cells, it can be
administered continuously until the tumors die. Docetaxel is widely
used as a treatment for eight different cancer types including
gastric cancer, lung cancer, and cervical cancer, so there are
plans to expand the target in fast track to other cancers while
conducting clinical trials for pancreatic cancer.
On the heels of Polytaxel, CNPharm has developed 'Polyplatin,' a
pain-free platinum-based anticancer drug targeting cervical,
bladder, and rectal cancer. CNPharm plans to expand the range of
diseases that can be treated with pain-free anticancer drugs using
its platform-based technology, such as Polytaxel and Polyplatin, to
combat various cancers as well as viral diseases.
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SOURCE Hyundai Bioscience