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Immuncell-LC of GC Cell, appointed as an Orphan Drug for Pancreatic Cancer by FDA of USA
2018-09-12

The appointment of Immuncell-LC of GC Cell as an orphan drug for pancreatic cancer was approved by Food and Drug Administration(FDA) of USA.

The Immuncell-LC of GC Cell, an immuno-anticancer agent approved by Ministry of Food and Drug Safety in 2007, has been produced and sold since then. The appointment as an orphan drug approved by FDA of USA is the third one after liver cancer(June) and brain tumors (glioblastoma) (August).

GC Cell has published results of clinical trials driven by researchers of the Immuncell-LC for patients suffering progressive pancreatic cancer in an SCI Journal of “Cancer Immunology, Immunotherapy” in June, 2014.

In the clinical trials driven by researchers for patients suffering the progressive pancreatic cancer in the Severance Hospital of Yonsei University, patients with pancreatic cancer were administered with the Immuncell-LC 10 times from which an average 25% of the rate of therapeutic response was identified. All patients with progressive pancreatic cancer participated in the clinical trial were of stage IV. They were primarily treated with Gemcitabine. Of them, 45%, 35%, and 25% experienced liver metastasis, lung metastasis, and lymph node metastasis, respectively.

GC Cell now plans to attain an easy approach to Biological License Application (BLA) based on development of a concrete strategy aiming for the market of pancreatic cancer in USA together with those of hepatoma and brain tumors already appointed as orphan drugs by FDA of USA.

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