Hyundai Bio Submits Clinical Trial Phase 1 Plan Approval Application for Politaxel Pancreatic Cancer to MFDS

Hyundai Bioscience (CEO Sang-gi Oh) announced on the 27th that it has applied to the Ministry of Food and Drug Safety for approval of a Phase 1 clinical trial to verify the safety and anticancer effects of Polytaxel in pancreatic cancer patients.

About 80% of pancreatic cancer patients are ineligible for resection surgery due to major blood vessel invasion by pancreatic cancer cells and metastasis to surrounding organs. Therefore, pancreatic cancer requires drug treatment using anticancer agents more than surgery. However, the development of pancreatic cancer treatments is very difficult, and even the developed and approved pancreatic cancer drugs have many side effects due to drug toxicity. There is a great need to develop pancreatic cancer treatments without side effects.

Polytaxel is a nano-sized polymer-drug conjugate, and unlike blood vessels around normal cells, it is selectively delivered to cancer cells through the blood vessels around tumors, which have a loose structure due to the absence of supporting cells nearby, and accumulates for a long time. Polytaxel is not delivered to normal cells, so it does not damage normal cells, allowing administration without a recovery period, and it remains in cancer cells for a long time, thereby inhibiting the progression of pancreatic cancer.

Hyundai Bioscience has demonstrated through experiments on a cancer cell-transplanted mouse model that Polytaxel administered within the No Observed Adverse Event Level (NOAEL) dose can treat cancer without side effects, so-called NOAEL therapy. The experiment showed that mice transplanted with pancreatic cancer tumors had a 100% survival rate and no weight loss when administered Polytaxel at a dose within the NOAEL limit (20 mg/kg). In contrast, the docetaxel group administered the same dose had a 0% survival rate and significant weight loss. The paper containing these experimental results was selected as the cover article of the Journal of Materials Chemistry B (JMCB), an international journal published by the Royal Society of Chemistry.

Hyundai Bioscience also recently demonstrated the non-toxicity, safety, and anticancer efficacy of Polytaxel through experiments on dogs with naturally occurring mammary gland cancer. The experiment involved administering Polytaxel at a dose within the NOAEL limit (4.5 mg/kg) three times at one-week intervals and observing the results three weeks later. No side effects such as inflammation, stress, bone marrow suppression, or weight loss were observed, and the size of the mammary tumors decreased by an impressive 76.78% compared to before administration. Notably, the size of tumors metastasized to lymph nodes also decreased by 74.01%, proving Polytaxel’s excellent efficacy in treating metastatic cancer.

Jin Geun-woo, Vice President of Hyundai Bioscience’s R&D division, said, "We applied for this clinical trial based on the non-toxic mechanism of Polytaxel and the results of mouse and dog experiments. Especially, since the safety and anticancer efficacy of Polytaxel were proven through the naturally occurring mammary gland cancer dog experiment, the prospects for the success of Polytaxel clinical trials have become even brighter."

Meanwhile, cases of health authorities such as the FDA and the Ministry of Food and Drug Safety designating new drug candidates for pancreatic cancer as orphan drugs or fast-track are increasing. Receiving orphan drug designation provides benefits such as shortened review periods, clinical trial cost support, and exclusive marketing rights for a certain period. Additionally, if fast-track designation is granted simultaneously, accelerated approval can be obtained to expedite commercialization.

CEO Sang-gi Oh of Hyundai Bioscience stated, "We plan to promptly conduct Phase 1 clinical trials and, based on the results, utilize the fast-track procedure applicable to pancreatic cancer treatments to conduct integrated Phase 2/3 clinical trials in the United States. We aim to bring forward the era where cancer treatment can be received without side effects from anticancer drug toxicity while maintaining daily life as much as possible."

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