[Click eStock] "Newgelab Pharma, Time to Focus on Promising Anticancer Drug Potential"

[Asia Economy Reporter Jang Hyowon] Hanyang Securities analyzed on the 21st that Newgelab Pharma is at a noteworthy stage as patient dosing has begun for the promising metabolic anticancer agent ‘KAT’. KAT is expected to have therapeutic effects through a direct injection method into liver cancer, and early data release is planned for this year.

Researcher Oh Byungyong of Hanyang Securities explained, “Newgelab Pharma is a company developing ‘KAT’, a novel anticancer drug that blocks cancer metabolism, and has been preparing clinical trials for ‘KAT’ for a long time. In August last year, it received IND (Investigational New Drug) approval from the U.S. FDA for liver cancer, and in April this year, it also obtained IND approval from the Korean Ministry of Food and Drug Safety. Clinical trials targeting liver cancer patients will be conducted at three hospitals in Korea and two in the U.S.,” he said.

Researcher Oh added, “Newgelab Pharma is currently awaiting IRB (Institutional Review Board) approval from Seoul National University Hospital, the main clinical site, and patient recruitment is expected to begin immediately upon IRB approval in August. The number of clinical trial patients is planned to be about 45 for phase 1 and 30 for phase 2a,” he stated.

He explained, “In this phase 1 clinical trial, Newgelab Pharma used an ‘Accelerated Titration Design’, recruiting one patient per dose at low doses to quickly escalate the dose, and recruiting three patients starting from doses where grade 2 or higher adverse effects appear. This shows their intention to quickly pass through low doses and strongly drive the trial from the early stages,” he said.

Researcher Oh said, “Phase 1 consists of three cohorts recruiting about 15 patients each: oral administration, I.T administration (direct injection into the tumor), and a combination of oral + I.T. Especially, the I.T method uses a catheter to directly inject the drug around the liver cancer target, which is expected to have relatively good therapeutic effects,” he explained.

He added, “‘KAT’ was originally developed by Dr. Ko Younghee, who has experience treating many cancer patients through the U.S. compassionate use program. One liver cancer treatment case was published in the 2012 ‘J BIOENERG BIOMEMBR’ academic journal. At that time, ‘KAT’ was administered via embolization to a 16-year-old liver cancer patient, and the cancer cells disappeared,” he explained.

Meanwhile, Newgelab Pharma is confident in the excellent efficacy of ‘KAT’ in clinical trials based on treatment data and plans to disclose data from a small number of early clinical patients to the market.

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