Local biopharmaceutical companies, including Sillajen, HLB, and Pharmicell, are competing to develop treatments for liver diseases and tapping the global market.
Sillajen, a Kosdaq-listed firm with more than 6 trillion won ($5.5 billion) market capitalization, is pinning its hope on liver cancer therapy Pexa-Vec. The immunotherapeutic drug uses vaccinia virus to make them selectively proliferate on targeted cancer cells only.
Various multi-country clinical trials on Pexa-Vec are in progress in Korea, France, and the U.S. The oncolytic drug has shown complete remission in previous clinical trials, raising expectations both in clinical and marketable aspects.
The drug also showed positive results in studies testing combination therapies with other immunotherapies such as Opdivo (ingredient: nivolumab) and Yervoy (ingredient: ipilimumab) to treat solid cancer, breast cancer, and soft tissue sarcoma. With oncolytic viruses showing better results in combination therapies than single ones, Pexa-Vec is drawing attention in the stock market, as well as the pharmaceutical industry.
LifeLiver, a subsidiary of HLB, is developing a liver treatment called HepaStem. Using stem cells extracted from liver, HepaStem is reportedly effective on urea cycle disorders (UCD), nonalcoholic steatohepatitis (NASH), and acute-on-chronic liver failure (ACLF). The possibility of treating NASH, in particular, HepaStem helped LifeLiver attract foreign investment including that of Mitsubishi. In Korea, the drug entered a phase-2b clinical trial. HepaStem is the only cell-based therapy in development for NASH.
Pharmicell is also a major player in liver treatment. The company is working on Cellgram-LC, using bone marrow-derived mesenchymal stem cell to treat hepatocirrhosis. The drug is in clinical trials, aiming to reduce fibrosis, a hardening of liver tissues damaged by alcohol, and to restore the function of the liver.
Pharmicell has completed a phase-2 clinical trial in Korea, submitted a phase-3 trial plan to the Ministry of Food and Drug Safety in June, and requested a review for conditional approval of the drug. The company hopes to receive the conditional approval within this year. On Nov. 4, it also asked for a permission of the Food and Drug Administration for a phase-1 clinical trial in the U.S.
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