Korean FDA approves Phase I/II clinical trial for VM106
ViroMed today announced Korean FDA approval of a Phase I/II clinical trial for VM106 - Retro-CGD®. Dr. Sunyoung Kim, CEO, said "This trial will be a proof-of-concept to show whether we can expand the use of our platform technology to a broad range of life-threatening diseases."
About CGD (Chronic Granulomatous Disease)
Chronic Granulomatous Disease (CGD) is a rare, genetic condition that affects four in a million people. People with CGD have a faulty bone marrow gene, which means that certain white blood cells do not function correctly. These are known as neutrophils, which are responsible for killing fungi and bacteria. Someone with CGD is more susceptible to fungal and bacterial infections. Medication is required continuously to keep infection at bay, but serious problems can arise that lead to life-threatening illnesses and prolonged periods in the hospital. In most cases, CGD patients die before the age of 30.
VM106 has been developed based on ViroMed’s proprietary retroviral vector. Since allogenic bone marrow transplantation can cure CGD, gene transfer into patient’s hematopoietic stem cells could provide the same benefits without immunological complications such as graft rejection. Retroviral vector-mediated gene therapy could be a promising alternative to hematopoietic stem cell transplantation for CGD, considering that the autologous cells will be administered to the patients after being loaded with the normal gene. Another beneficial element to CGD gene therapy is that full restoration of NADPH oxidase activity is not required for patients in order to overcome repeated infections.