Hyundai Bio Begins Phase 3 Clinical Trial of 'Mugotong' Pain-Free Anticancer Drug Exclusively for Companion Dogs

Hyundai Bio announced on the 13th that it is conducting drug administration experiments on companion dogs to obtain product approval by next year for Polytaxel, a so-called "pain-free" anticancer drug developed to concentrate its efficacy only on cancer cells without damaging normal cells, as a dedicated anticancer drug for companion dogs.

Hyundai Bio stated that in the "efficacy experiment for the phase 3 clinical trial of companion dog anticancer drugs," currently underway under the approval of the Animal Experiment Ethics Committee at 'Culp,' a CRO specializing in animal drug clinical trials, Polytaxel was administered to companion dogs with naturally occurring mammary cancer, demonstrating excellent safety and efficacy.

The phase 3 clinical trial for product approval of the companion dog anticancer drug requires an application process to the Animal and Plant Quarantine Agency under the Ministry of Agriculture, Food and Rural Affairs, which has the authority to approve product licenses. The number of companion dogs involved in the ongoing experiment can be combined with the scale of phase 3 trials. This means Hyundai Bio has effectively started phase 3 clinical trials with this experiment.

In this experiment, companion dogs were administered 4.5 mg/kg of Polytaxel, which is below the No Observed Adverse Effect Level (NOAEL) without a recovery period, once a week for three consecutive weeks. Observations three weeks later showed that the size of mammary tumors decreased by an impressive 76.78% compared to before administration. Notably, the size of tumors metastasized to lymph nodes decreased by 74.01%, proving Polytaxel's excellent efficacy in treating metastatic cancer as well.

The company reported that companion dogs administered Polytaxel showed no abnormal symptoms in the liver and kidneys, no weight loss, no increase in stress levels, no bone marrow suppression, or platelet reduction, and even ate well. Typically, dogs with cancer lose vitality and have poor appetite.

Dr. Seongho Hwang, director of Culp, who conducted the experiment, said, "In over 30 years of conducting animal tests, this is the first time I have experienced a drug with excellent anticancer effects without any liver or kidney damage and without bone marrow function decline." He added, "This is exactly the kind of anticancer drug needed by companion dogs worldwide, one without side effects."

Hyundai Bio plans to conduct a large-scale phase 3 clinical trial for companion dog anticancer drugs after applying to the Ministry of Agriculture, Food and Rural Affairs, following the ongoing efficacy experiment, to swiftly obtain product approval for Polytaxel as a companion dog anticancer drug.

Currently, there is no suitable dedicated anticancer drug for companion dogs worldwide, so human anticancer drugs are used. However, these cost millions to tens of millions of won, and due to severe drug side effects, effective anticancer treatment is often not properly achieved.

Meanwhile, the results of this experiment have also increased the possibility of developing a pain-free anticancer drug for humans. Regarding this, Hyundai Bio CEO Sanggi Oh said, "Based on the results of this companion dog experiment, we will promptly prepare a clinical plan for Polytaxel to treat pancreatic cancer patients and apply to health authorities," adding, "Our company's goal is to open the era of pain-free anticancer drugs."

The tumors in the companion dogs participating in this experiment occurred naturally, similar to humans, and the results of the companion dog experiment brighten the prospects for human clinical trials. Dr. Geunwoo Jin, Vice President of Hyundai Bio, said, "Five years ago, Polytaxel demonstrated excellent safety and efficacy in a pancreatic cancer xenograft mouse model," adding, "By proving safety and efficacy in naturally occurring mammary cancer in companion dogs, which are much more sensitive to anticancer drug toxicity and side effects than humans and mice, the likelihood of success in human clinical trials has also increased."

Polytaxel also raised expectations for the birth of a pain-free anticancer drug by showing results such as a 90.4% reduction in tumor tissue and 100% survival rate without weight changes in experimental subjects in a 2019 experiment using a pancreatic cancer xenograft mouse model.

Existing chemotherapy drugs have severe drug toxicity and are administered at doses dozens of times higher than the maximum non-toxic dose during anticancer treatment, causing toxicity that damages not only cancer cells but also normal cells. Patients suffer from bone marrow function decline, liver and kidney abnormalities, weight loss, increased stress levels, hair loss, and other hardships. Therefore, patients must have a recovery period of 2 to 3 weeks after one anticancer drug administration to allow normal cells to recover.

This content was produced with the assistance of AI translation services.