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GC Cell gets FDA orphan drug designation for Immuncell-LC
  • By Marian Chu
  • Published 2018.08.20 12:09
  • Updated 2018.09.12 14:08
  • comments 0

GC Cell said Friday that it got an orphan drug designation from the U.S. Food and Drug Administration for its anticancer immunotherapy Immuncell-LC to treat glioblastoma, the most aggressive cancer that begins in the brain.

Immuncell-LC

The Korean pharmaceutical firm won approval for Immuncell-LC to treat liver cancer from the Ministry of Food and Drug Safety in 2007.

Immuncell-LC is a customized anti-cancer drug that is made from a patient’s blood. Professionals extract a sample of a patient’s T-cells from the blood and genetically modify it into a robust immune cell that has maximized anticancer functions and incubated for about two weeks before they infuse it into the patient.

The therapy was also designated as a rare drug for liver cancer treatment in the U.S. in June this year.

"We received the FDA's rare drug approval for hepatocellular carcinoma, brain tumor, and pancreatic cancer,” GC Cell CEO Lee Deuk-joo said. “We expect to be able to obtain U.S. product licenses under favorable terms."

The recent designation is likely to open up a smooth road to treatment development and approval, according to the firm. Companies with rare drug designations receive a variety of benefits that include tax breaks and exemption from fees related to new drug approval review. They are also eligible for a seven-year exclusive monopoly after getting marketing authorization.

GC Cell shares jumped nearly 30 percent Friday to close at 45,570 won ($40). Shares of its parent company, GC, also surged 5.59 percent while GC Holdings rose 6.95 percent.

Since 2008, GC Green Cross Cell has conducted phase 3 trials in 180 patients with brain tumors. International medical journals Immunotherapy and Oncotarget published the research papers in 2017 and 2016, respectively.

yjc@docdocdoc.co.kr

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