[Edaily Reporter YU JIN-HEE ] #HYUNDAI BIOSCIENCE CO., LTD.’s new anticancer drug candidate “Penitrium” (CP-PCA07) will continue treatment as determined by the medical team immediately after completing the first patient dosing in a Phase 1 clinical trial for prostate cancer in South Korea.

HYUNDAI BIOSCIENCE CO., LTD. announced on the 9th that the first patient in the lowest-dose group of its Phase 1 clinical trial for castration-resistant prostate cancer, currently underway at Seoul National University Hospital, has completed 12 weeks of treatment. The company further reported that on the 6th, the lead clinical physician formally submitted and had accepted an application for “individual treatment-use approval” with the Ministry of Food and Drug Safety to prevent a gap in the patient’s treatment and ensure the continuity of therapeutic effects.

Individual Treatment Use Approval is a system under which the Ministry of Food and Drug Safety authorizes the administration of pre-approved investigational drugs to critically ill patients whose lives are at risk or who have no alternative treatment options.

The patient covered by this application received the lowest dose of Penitrium—600 mg per day—in combination with the existing standard treatment, enzalutamide, for the planned 12-week treatment period. After the 12-week treatment schedule ended on the 2nd, the attending physician at Seoul National University Hospital carefully reviewed the patient’s treatment progress and overall condition and determined that an additional 6 months (180 days) of treatment was necessary.

Although Phase 1 clinical trials are an early stage primarily intended to verify a drug’s safety and tolerability, this case is significant because the medical team directly requested an extension of treatment and followed the procedures of the Ministry of Food and Drug Safety.

In response to the attending physician’s request, HYUNDAI BIOSCIENCE CO., LTD. issued a letter of intent on the 5th stating that it would supply the full 180-day supply of Penitrium (a total of 1,080 tablets) free of charge. The company plans to provide the medication as soon as approval from the Ministry of Food and Drug Safety is granted and will continue to provide support should further extensions be necessary in the future.

Penitrium is a “pseudo-resistance” targeted anticancer candidate that modulates the tumor microenvironment to facilitate the delivery of anticancer drugs to cancer cells. Its mechanism of action involves alleviating the physical barriers caused by the stiffening of cancer-associated fibroblasts (CAFs) and the extracellular matrix (ECM), thereby increasing the response rate to existing drugs.

The compound secured global competitiveness last September when it received a “Study May Proceed” approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2a clinical trial for recurrent or refractory advanced solid tumors. The company plans to continue enrolling patients and conducting dose-escalation trials in its domestic Phase 1 study while simultaneously conducting the U.S. Phase 2a trial to verify the efficacy of combination therapy.

Jin Geun-woo, CEO of HYUNDAI BIOSCIENCE CO., LTD., stated, “Following the FDA’s approval to proceed with the Phase 2a trial, an application has been submitted to extend treatment for patients in the lowest-dose group of the domestic Phase 1 trial,” adding, “We will actively support treatment opportunities for patients while demonstrating the potential of this new combination therapy through objective clinical data.”