by Jang Hyowon
Published 13 Apr.2022 14:45(KST)
[Asia Economy Reporter Jang Hyowon] NewGelLabPharma's subsidiary, NewGelLabPharma USA, announced on the 13th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the Phase 1+2a clinical trial of the anti-cancer agent KAT (Ko Anti-cancer Technology) targeting liver cancer. NewGelLabPharma had previously obtained clinical approval from the U.S. Food and Drug Administration (FDA) last year.
The domestic clinical trial of KAT will be conducted with the same structure as in the United States. NewGelLabPharma plans to verify the ‘Objective Response Rate (ORR)’, ‘Disease Control Rate (DCR)’, ‘Progression-Free Survival (PFS)’, and ‘Overall Survival (OS)’ of KAT monotherapy targeting liver cancer and determine the optimized dosage.
NewGelLabPharma designed this clinical trial as an ‘Open Label’ study (a method in which both the subjects and investigators know whether the test drug or control drug is being used). This allows the efficacy data observed during the clinical process, such as Complete Response (CR) and Partial Response (PR), to be announced even during the trial.
A representative of NewGelLabPharma stated, “KAT has been sufficiently validated for efficacy through numerous preclinical trials and emergency clinical treatment cases, so we expect to announce positive efficacy data soon.” He added, “Since Korea has a larger number of liver cancer patients than the U.S., the clinical trial can proceed at a faster pace.”
He continued, “We expect to accelerate the commercialization of the anti-cancer agent KAT through a multinational clinical trial conducted simultaneously in Korea and the U.S.,” and added, “We will strive to provide hope to patients suffering from liver cancer, for which there is currently no effective treatment.”
KAT is a new anti-cancer drug candidate that uses a substance called ‘3BP (3-Bromopyruvate)’ to block the unique energy metabolism of cancer cells and selectively induce apoptosis only in cancer cells. Existing anticancer drugs kill cancer cells by binding to receptors or immune-specific substances on the outer membrane of cancer cells, but KAT has a mechanism that allows the drug to directly enter inside cancer cells.
Existing anticancer drugs have limitations in that they are effective only for certain cancer types because receptors vary depending on the cancer type. In contrast, KAT is a universal therapeutic candidate that can treat almost all cancer types by selectively entering cancer cells and blocking the energy production process inside the cells, thereby inducing cell death.
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