Green Cross, Hunter Syndrome Treatment 'Hunterlase' Receives Phase 1 Clinical Trial Approval

GC Green Cross Severe Hunter Syndrome Treatment 'Hunterase'

[Asia Economy Reporter Lee Chun-hee] GC Green Cross announced on the 7th that it has received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial of the severe Hunter syndrome treatment 'Hunterase ICV' (development name 'GC1123').

Hunterase is the world's first commercially successful treatment for severe Hunter syndrome. It received the world's first marketing authorization in Japan in January last year. In the Japanese clinical trial, Hunterase ICV significantly reduced 'heparan sulfate (HS)', a key substance causing central nervous system damage, and showed effects of maintaining or improving developmental age. This treatment method involves inserting a device into the head to directly administer the drug into the brain ventricle, improving on existing intravenous formulations that cannot cross the blood-brain barrier (BBB) and thus fail to reach the 'brain parenchymal tissue'.

The current domestic Phase 1 clinical trial is being conducted at three domestic institutions?Samsung Seoul Hospital, Seoul National University Hospital, and Yangsan Pusan National University Hospital?targeting 12 patients with severe Hunter syndrome to evaluate the safety and efficacy of the drug. The company explained that about 70% of all Hunter syndrome patients exhibit neurogenic symptoms, indicating a high unmet medical need.

A GC Green Cross official stated, "We will continue to strive to improve the quality of life for patients with rare diseases," adding, "Since this product has already been successfully commercialized overseas, we will do our best to supply it to domestic patients as well."

This content was produced with the assistance of AI translation services.