Polytaxel, a novel pain-free anticancer drug, may not require break periods
A new standard of care, more convenient than docetaxel, is suggested
Hyundai Bioscience to enter clinical trial on pancreatic cancer in Australia
Patient-centered chemotherapy to enable outpatients to live normal lives
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 has announced 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 trial institution.
"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 toxicity."
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 animals."
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.
The number of international medical tourists visiting Korea increased by 25% from 110,000 in 2020 to 140,000 in 2021 despite the impact of the COVID-19 pandemic.
Korea is one of the most advanced countries in medical technology, excelling in major medical surgeries and treatment across various specialties, including cancer, cardiovascular disease, organ transplantation, spine, infertility, and physiotherapy.
Korea has been awarded by the International Medical Travel Journal (IMTJ) for "Health and Medical Tourism: Destination of the Year" for two consecutive years, being globally recognized for its competitiveness in medical tourism. Over 3 million patients visited Korea to receive medical treatment in Korea since 2009.
Internal medicine attracted the most international patients to Korea, followed by physical examination. Plastic surgery and dermatology ranked 3rd and 4th, respectively. The number of foreign patients visiting Korea is expected to rise in the post-pandemic era.
Medical Korea's website www.medicalkorea.or.kr is operated by the Korea Health Industry Development Institute (KHIDI) as an official website of the Korean government and provides information and statistics related to Korea's medical services available to foreign patients. It is a one-stop service for international tourists visiting Korea for medical treatment.
Information on operations and treatment of medical specialties, including oncology, cardiology and organ transplantation, are available on the Medical Korea website, which has a list of clinics and hospitals designated to treat foreign patients.
It also offers various other essential information for visiting Korea, such as the types of medical visas, visa processing, and tax refund for cosmetic surgery. It also details health guidelines for severe diseases, such as cerebral infarction, breast cancer and respiratory diseases, as well as daily activities for enhancing immunity and concentration.
The website also provides information on Korean government agencies, associations, and medical institutions as well as other essential information for visiting Korea, such as medical visas. Medical Korea's official website is available in four languages: English, Chinese, Japanese, and Russian.
Click the link below to visit the website for details. medicalkorea.or.kr
Korea Health Industry Development Institute (KHIDI) is a government-affiliated institution operating under the Ministry of Health and Welfare of the Republic of Korea. KHIDI was established in 1999 with the purpose of providing professional and systematic support for development of Korean healthcare industry in order to enhance its competitiveness on a global scale.
Its aim is the promotion of advanced healthcare services with a long-term perspective to turn the healthcare business into a new growth engine for Korea's creative economy. it is striving to generate the 'Korean-wave' in the global healthcare industry by combining the strength of Korea's medical services, pharmaceutical products, medical devices and cosmetics.