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GC Pharma to proceed with P2/3 trial for hepatitis B immunoglobulin
  • By Lee Han-soo
  • Published 2018.01.18 11:28
  • Updated 2018.01.18 11:28
  • comments 0

GC Pharma, formerly known as Green Cross, said Thursday it has received approval from the Ministry of Food and Drug Safety to go ahead with phase 2/3 clinical trials for GC1102, a new recombinant hepatitis B immunoglobulin.

GC1102, also known as Hepabig-gene, employs immunoglobulins made from genetic recombination technology as its primary treatment source and prevents the recurrence of hepatitis B virus infection following liver transplantation.

Genetic recombination technology has broad applications in drug developments, including insulin and growth hormone. However, there have been no successful cases of hepatitis B immunoglobulin utilizing the technology, making the company’s treatment closest to commercialization worldwide.

The phase 2/3 clinical trial, which is the final step in the development phase, will evaluate the optimal dose of Hepabig-gene and evaluate its efficacy against existing treatments for liver transplant recipients with hepatitis B as the underlying disease in nine medical institutes.

According to the company, the treatment’s purity is higher than that of the existing plasma-derived product. It also has high virus-suppressing abilities and reduced drug administration time than conventional drugs.

The drug administration time can also fall to one-sixtieth of that of the conventional product.

Also, since the problem of limited imports of special plasma, which is the raw material of existing products, is eliminated, it is possible to respond flexibly to demand. Such aspects can lead to a reduction in manufacturing cost, which can lower the burden on the patient.

Based on the drug's improvements, both the U.S. Food and Drug Administration and European Medicine Agency assigned orphan drug status to it in 2014.

"Currently available treatments that are effective for hepatitis B recurrence following liver transplantation are hepatitis B immune globulin derived from human plasma,” GC Pharma President Hun Eun-chul said. “GC1102, which does not contain plasma-based additives, may offer innovative and more effective alternatives, as there are no other recombinant treatments available.”

The company believes GC1102 has potential to change the current treatment paradigm for hepatitis B patients, Huh added.

The phase 2/3 clinical trials are expected to take around five years to complete.

corea022@docdocdoc.co.kr

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