The Ministry of Food and Drug Safety (MFDS) has approved Kolon Life Science to conduct phase 3 clinical trials to expand treatment for Invossa-K injection, the world’s first-in-class cell gene therapy to treat osteoarthritis of the knee.
The ministry initially approved the treatment for treating patients with Kellgren & Lawrence (K&L) grade 3 and patients who have sustained symptoms despite three months of conservative therapy.
K&L system is a method of classifying the severity of knee osteoarthritis using five grades from zero to five with five being the highest.
The research, which aims to extend treatment to K&L grade 2 patients, will examine 146 patients with knee osteoarthritis in a randomized, placebo-controlled, single-blind, parallel design and multicenter-controlled clinical trials at 17 institutions for two years from next January.
The company expects to expand treatment of Invossa-K injection to 1.8 million patients with either K&L 2 or K&L 3 out of the total 2.7 million people with knee osteoarthritis in Korea.
“The biggest goal of this clinical trial is to expand treatment to K&L grade 2 patients,” said Lee Woo-sok 이우석, CEO of Kolon Life Science 코오롱생명과학. “The company hopes to help improve quality of life by providing new treatment options for patients suffering from osteoarthritis.”
Kolon also expects the additional clinical trial will prove the possibility of Invossa-K injection as a new alternative to more patients in the global drug market, he added.
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