National Center for Child Health and Development Initiates Phase 1/2 Trial of Green Cross' idursulfase-beta ICV for the Treatment of Hunter Syndrome with Neurocognitive Decline

Address the Significant Unmet Need of Improving the Cognitive Decline in MPSII Patients

YONGIN, South Korea, Oct. 26, 2016 /PRNewswire/ -- Green Cross Corporation (Green Cross) (KRX: 006280), a South Korean biopharmaceutical company, and the National Center for Child Health and Development (NCCHD) in Japan announced today that the first patient has begun treatment in a Phase 1/2 clinical trial for GC1123 (idursulfase-beta ICV), an investigational formulation of idursulfase-beta for the treatment of neurocognitive decline associated with Hunter syndrome (also known as mucopolysaccharidosis type II or MPSII).

This formulation is being studied for use with Green Cross' currently approved treatment for Hunter syndrome, Hunterase (idursulfase-beta), which is administered intravenously and does not penetrate the blood brain barrier in clinically adequate amounts. GC1123 is delivered directly to cerebral ventricles by intracerebroventricular (ICV) administration, in order to reach the cells of the brain and central nervous system.

Hunter syndrome is a lysosomal storage disorder caused by inadequate activity of the enzyme iduronate-2-sulfatase, which leads to severe clinical complications and early mortality. Two thirds of Patients with Hunter syndrome manifest cognitive impairment.

"Hunter syndrome with neurocognitive impairment has long been a difficult condition to treat due to challenges in effectively delivering a therapy that bypasses the blood brain barrier," said Hyi Jeong Ji, Ph.D., Senior Vice President at Green Cross Corporation. "This study will provide important clinical insights into our approach to deliver enzyme replacement therapies directly to the brain."

"Patients with Hunter syndrome especially with neurological complications need therapies that target the cause of this fatal disorder that currently have no approved treatment options," said Torayuki Okuyama, M.D., Director of Clinical Laboratory Medicine at NCCHD and principal investigator for this study. "This is a critical first step to finding potential treatments."

About Green Cross Corporation

Green Cross Corporation is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, Green Cross is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for nearly half a century.

About NCCHD

The National Center for Child Health and Development (NCCHD), based in Tokyo, Japan, is national medical center in Japan; specialized in medical care and research for child health and development.

This release includes forward-looking statements, which express the current beliefs and expectations of management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.