GC Green Cross Cell Launches Phase 3 Clinical Trial of "Immuncell-LC Injection" for Pancreatic Cancer

GC Green Cross Cell CI (Photo by GC Green Cross Cell)

[Asia Economy, reporter Lee Chunhee] The Phase 3 clinical trial of GC Green Cross Cell’s anticancer drug “Immuncell-LC Injection” for pancreatic cancer has officially begun.

GC Green Cross Cell announced on September 7 that the first patient has been enrolled in the Phase 3 clinical trial of Immuncell-LC Injection for pancreatic cancer. The company received approval for the Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety in December 2020, and plans to conduct the trial at clinical sites including Seoul National University Hospital, enrolling 408 pancreatic cancer patients to evaluate the addition of a new indication.

Immuncell-LC Injection was previously approved as an anticancer drug for liver cancer in 2007, and last month, it was also approved as an advanced biopharmaceutical under the Advanced Regenerative Bio Act.

This clinical trial will evaluate efficacy and safety by dividing patients with pancreatic ductal adenocarcinoma who have undergone curative resection into two groups: a standard treatment group receiving gemcitabine monotherapy, and a combination therapy group receiving both Immuncell-LC Injection and gemcitabine. The combination therapy group will receive 16 additional doses of Immuncell-LC Injection on top of standard gemcitabine treatment.

The primary endpoints include recurrence-free survival (RFS), overall survival (OS), and changes in the tumor marker CA19-9, all evaluated for the combination therapy group.

Pancreatic cancer has a five-year survival rate of 12.6%, the lowest among the top ten cancers. Since cancer survival statistics began in 1993, the five-year survival rate for other cancers has increased by 27.4%, while for pancreatic cancer, the increase has been only 2.0%, making it one of the most difficult-to-treat diseases.

Lee Deukjoo, CEO of GC Green Cross Cell, stated, “Developing treatments for pancreatic cancer is a challenging field, with many multinational pharmaceutical companies having experienced failures. However, since our investigator-initiated trial (IIT) for end-stage pancreatic cancer patients announced in 2014 showed significant potential, we expect positive results from this Phase 3 clinical trial as well.”

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