KOSDAQ-listed ViGenCell rose sharply early on the 26th on news that it secured statistical significance in a phase 2 clinical trial for a rare lymphoma drug.
As of 9:47 a.m. that day, ViGenCell was trading at 4,555 won, up 1,050 won (29.96%) from the previous session. ViGenCell hit the upper price limit (the top of the daily price band) right after the open.
ViGenCell, a new drug development company, said after the regular session closed the previous day that it disclosed key indicator results showing statistical significance for the phase 2 trial of "VT-EBV-N," an NK/T-cell lymphoma treatment.
The trial was conducted using randomization and a double-blind design at 13 medical institutions nationwide, including Seoul St. Mary's Hospital. Dosing for 48 patients with NK/T-cell lymphoma was completed in Sep. 2023, followed by two years of follow-up observation.
In the trial results, the primary efficacy endpoint, 2-year disease-free survival (DFS), was 95.0% in the treatment group and 77.58% in the control group. The difference between the two groups was analyzed as statistically significant (p=0.0347). In the treatment group, the incidence of relapse or death events was only 4.76% (1 patient). No serious adverse reactions were reported for safety.
ViGenCell plans to issue a follow-up disclosure after securing the final clinical study report (CSR) early next year. The company said, "VT-EBV-N was designated as an orphan drug in development by the Ministry of Food and Drug Safety in 2019, and based on this we plan to seek priority review designation and pursue conditional approval."