Korea's Pharmicell gets FDA approval to start phase I study of liver cirrhosis treatment

South Korea’s biotech company Pharmicell Co. has received a go-ahead from the U.S Food and Drug Administration (FDA) to start a phase I clinical study with its Cellgram-LC stem cell drug for treating alcoholic liver cirrhosis, the company announced Monday.

Pharmicell’s Cellgram-LC, dubbed Cellgram TM in the U.S., is liver cirrhosis treatment that uses bone marrow-derived mesenchymal stem cell. The treatment is designed to reduce fibrosis, a hardening of liver tissues damaged by alcohol, and restore functions of liver.

Following the FDA’s approval, the Korean pharmaceutical company will embark on a phase I study of Cellgram-LC on patients suffering from alcoholic liver cirrhosis at the University of Utah Hospital in the U.S., said the company.

Pharmicell shares jumped 12.64 percent on Monday and finished at 6,150 won ($5.65).

The number of liver cirrhosis patients is growing every year but the currently available treatment is liver transplantation, said a Pharmicell official, adding that the company aims to complete clinical trials on its new liver cirrhosis treatment as early as possible to give new hopes to people suffering with the liver disease.

Pharmicell has completed phase II clinical study of Cellgram-LC stem cell treatment in Korea and plans to file for conditional approval of the new drug in the country by the end of this year. Alcoholic liver fibrosis has been recognized as an irreversible serious illness in Korea.

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