GC LabCell gets approval for Phase 1 trials of CT303

GC LabCell's headquarters in Yongin, Gyeonggi [GC PHARMA]

GC LabCell won approval to start Phase 1 clinical trials of CT303, its treatment candidate for acute respiratory distress syndrome (ARDS).

With permission from the Ministry of Food and Drug Safety, the clinical trials will involve a total of eight patients to test safety, tolerability and efficacy.

The trials will take place locally. Seoul National University Hospital and Seoul Metropolitan Government-Seoul National University Boramae Medical Center are participating.

ARDS is a life-threatening lung disease in which fluid leaks into the lungs. The mortality rate for ARDS is around 45 percent, and there is no cure for this disease to date, according to the company.

GC LabCell said its animal tests of CT303 have produced meaningful results confirming its effectiveness against serious lung diseases such as pulmonary edema.

“Starting with this, we strive to expand our development of third-generation stem cell treatments,” Hwang Yu-kyeong, head of GC LabCell’s cell therapy research center, said.

BY SARAH CHEA [chea.sarah@joongang.co.kr]