Green Cross plans phase 2 trial of immunoglobulin
음성듣기
Hepatitis B therapy to be tested for liver transplant patients
By Jung Min-ho
Green Cross has received approval from the Ministry of Food and Drug Safety to develop what the company says is the world's first genetically recombined hepatitis B antibiotic therapy, in the form of an artificial immunoglobulin.
Unlike existing immunoglobulin, which comes from plasma from donated blood, the new product is purer and will therefore act faster and require lower doses to achieve the same effects, the company said.
In a statement issued Wednesday, the company said it had received the green light for a phase 2 clinical trial of the new drug, Hepabig-Gene, which will involve patients recovering from liver transplants.
If the project succeeds, Green Cross will become an influential player in the world market for hepatitis B treatments.
"The initiation of the clinical trial is an important step forward," Ji Hyi-jeong, senior vice president of Green Cross, said. "If Hepabig-Gene is proven safe and effective, it will be the first recombinant Hepatitis B [immunoglobulin] and an alternative treatment choice for physicians and their patients who undergo [the most common kind of] liver transplantation."
Both the European Medicine Agency and the U.S. Food and Drug Administration granted orphan drug designation for Hepabig-Gene last year.
Orphan drugs are drugs developed specifically to treat rare conditions, making them less profitable to develop under normal market conditions, so manufacturers may be eligible for assistance in bringing these new drugs to market.
Although hepatitis B is a global public health issue, affecting up to 350 million people worldwide, patients recovering from liver transplants represent a small group who lack the purchasing power to create a new market.
Chronic hepatitis B patients face a considerably increased risk of developing cirrhosis (a disease in which scar tissue and nodules replace liver tissue) and hepatocellular carcinoma (the most common type of liver cancer).
Liver transplantation is the usual treatment for patients with liver failure and hepatocellular carcinoma. About 700 liver transplants are performed annually in Korea alone.