Chemotherapy can be completed in 8 days with two doses of Polytaxel, a breakthrough cancer drug from the South Korean biotech firm.

Chemotherapy can be completed in 8 days with two doses of Polytaxel, a breakthrough cancer drug from the South Korean biotech firm.
  • Politaxel, a novel without pain cancer medication, may not require rest periods
  • A new standard of care is suggested, more convenient than docetaxel
  • Hyundai Bioscience to start a clinical trial on pancreatic cancer in Australia
  • Patient-focused chemotherapy to enable outpatients to lead normal lives

Seoul, South Korea, November 25, 2022 /PRNewswire/ — An innovative cancer therapy that can complete chemotherapy with two doses of an anticancer drug in as little as 8 days will enter a clinical trial for cancer patients.

This chemotherapy is a patient-centered treatment that focuses on controlling the toxicity of the cancer drug. This unprecedented chemotherapy is expected to help cancer patients receive outpatient treatments without side effects and lead normal lives at home and at work.

Hyundai Bioscience announced the November 24, 2022which is collaborating with an Australian cancer hospital for its global Phase 1 pancreatic cancer clinical trial of Polytaxel, which was developed as a so-called ‘painless’ anti-cancer drug, based on a new nanohybrid inorganic polymer Drug delivery platform technology. Polytaxel is loaded with docetaxel as the active pharmaceutical ingredient, which is known as one of the leading chemotherapy drugs. Hyundai Bioscience will submit 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.

Hyundai Bioscience held a press conference at Ewha Womans University on November 22thand unveiled its clinical trial design for Polytaxel in conjunction with NOAEL therapy, an innovative cancer therapy that can be administered without recovery rest periods.

“Polytaxel’s clinical design has a 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 has emerged to enable painless anti-cancer treatment.”

Hyundai Bioscience’s clinical trial design is essentially to administer Polytaxel at 7-day intervals 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 the administration and 15 days for the three-dose group. Existing chemotherapy with docetaxel usually takes 3-6 months due to the fact that there should be a 3-week recovery period between doses.

It is notable that such a 7-day interval dosing frequency is the same as applied to animal tests. In case of conventional chemotherapy, patients must have a recovery period after drug injection due to severe side effects caused by drug toxicity. That is why the dosing range of efficacy tests on animals is not adopted in the same way as human tests are generally.

Mr. Park said: “Politaxel showed excellent therapeutic efficacy in tumor remission by 67% up to 83% with just three doses on days 1, 8 and 15 in preclinical trials. However, there was no decrease in the body weight, the most important indicator of toxicity.

Dr. jin geun woo, Director of R&D at Hyundai Bioscience, said: “Cytotoxic drug-based chemotherapy has not made significant progress for several decades because the dosage range applied to animals cannot be directly applied to humans due to the toxicity of the drug. drug”. He explained: “It is inevitable that humans 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 that recovery period.

Dr. Jin said, “We have conducted dozens of animal tests with the goal of applying the same dosing range to animals and humans, and finally found the right dosing range to satisfy you.” He said: “Politaxel is a safe drug that is effective even if administered below the non-toxic level, allowing the same dosing range to apply for both humans and animals.”

Pancreatic cancer is known as one of the most difficult types to cure and 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 nearly impossible and drug delivery is structurally difficult. In the past 20 years since 2003, 174 candidates have been designated as orphan drugs for the treatment of pancreatic cancer by the US Food and Drug Administration (FDA), but only three have been approved.

Mr Park explained: “The decision to select pancreatic cancer as the clinical destination indication for Polytaxel is part of our strategy to accelerate the fast-track approval process by demonstrating the safety and efficacy of Polytaxel in the most intractable cancer”. He said: “In the pharmacokinetic study we conducted in from Japan Sekisui Medical, although Polytaxel was verified to be a polymeric substance, it delivers well to the pancreas, which is known to be difficult to reach in drug delivery.”

Lee Hwa JeongProfessor of Pharmacy at Ewha Womans University, who was a panelist at the conference, said: “It is very impressive that Polytaxel achieved a concentration in tumors 10 times that of normal tissue in the preclinical study, demonstrating great property directed at tumors.” peter koo, a former professor at Yale University School of Medicine, said: “It will be a positive, if Polytaxel is successfully approved, we will have more options for cancer combination therapy.” Mr. Koo also recommended continued research into the use of immuno-oncology drugs in combination.

Hyundai Bioscience has undergone 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 without pain chemotherapy. NOAEL therapy is a novel therapy in which Polytaxel is delivered below the No Observed Adverse Effect Level (NOAEL) in vivo so that cancer can 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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SOURCE Hyundai Bioscience

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