Pharmicell submits commercialization plan on new therapy
By Yun Suh-young
A way to revive failed livers through stem cells could be available within the next few years as clinical tests of a new treatment regimen are underway.
Pharmicell, a Korean pharmaceutical company developing stem cell therapeutics, said Monday that it has submitted a plan for the commercialization of “Livercellgram,” a stem cell therapy for liver failure, to the Korea Food and Drug Administration (KFDA).
The company said that it successfully completed research trials, which began in 2009, and confirmed that the therapy was effective in curing alcohol induced cirrhosis. The company will begin secondary stage clinical trials if the plan is approved by the KFDA.
If the product is approved, Pharmicell will be the first beneficiary of a revised rule made by the KFDA last year which allows research trials to replace a first round of clinical trials.
If Livercellgram is fully developed and approved for commercialization, it may revive degenerated liver cells, enhance liver performance and reduce other complications. It will open the way for liver disease patients to receive effective and cheaper cures at only one fourth the price of getting a transplant.
“Thanks to the revision of the rule by the KFDA, the commercialization of the therapeutic drug will be accelerated. If the drug is commercialized, it will become the best cure for liver patients who had no real means to receive treatment,” said a Pharmicell researcher.
Until now, there has been no cure for liver cirrhosis except undergoing a transplant. This can be problematic due to the limited number of donors and cases of rejection. The cost of operations is also high.
Liver cirrhosis is the number one cause of death among males in the 40 to 50 age group and the eighth biggest cause of death for all Koreans. In 2010, nearly 7,000 people died of the disease.
According to research by the World Health Organization (WHO), about 1.4 million people die every year due to the disease and Korea is the leading nation among members of the Organization for Economic Cooperation and Development (OECD) in terms of the number of deaths.
Liver cirrhosis develops when a person engages in too much drinking or has a chronic infection. The liver hardens and its function deteriorates; it may also sometimes develop into cancer.