Home China FDA Approves Korean Gene Therapy Venture for Osteoarthritis Clinical Trials

FDA Approves Korean Gene Therapy Venture for Osteoarthritis Clinical Trials

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Jeong Sae-Im writing for Korea Biomedical Review reports that Kolon Life Science  has obtained US FDA IND approval to conduct a phase 1/2a clinical trial based on a gene therapy for neuropathic pain known as KLS-2031.

Kolon Life Science’s KLS-2031 is targeting osteoarthritis cell gene therapy Invoassa-K.  It will be consumed via injection.  According to Jeong Sae-Im’s article, the first delivery by the GAD 65 gene suppresses the pain signal to the brain and the second one by the GDNF and the IL-10 gene protects the injured nerve and prevents inflammation.

They report Kolon developed the treatment as a single topical injection to make analgesic effects long lasting. The investigational treatment has been developed for patients with neuropathic pain who don’t do well with conventional treatments.  Kolon now can plan for a study to start within the year for 18 participants at two clinical institutions within the U.S. over the next 24 months.

CEO Lee Woo-Suk reports that “the FDA’s approval for the clinical trials KLS-2031 will be an opportunity for us to be recognized as a gene therapy specializing company in the global market and promote korea advanced gene research capabilities in the biotech sector.”

Kolon Life Sciences Background

Founded in 2000, Kolon has been developing innovative cell and gene therapeutics and currently had 5 projects in its development pipeline including the world’s first cell mediated gene therapy for Osteoarthritis.

Kolon recently celebrated a commercial deal in China.  It entered into an agreement with a Chinese healthcare provider to export Invossa, the injectable cell gene therapy for osteoarthritis in a deal purported to be worth U.S. $203.5 million.  In this partnership, the Chinese healthcare organization will supply the island province of Hainan—a province China is marketing as a medical tourist destination. China Life Medical will be in charge of regulatory approval, sales and marketing.

Kolon has inked other distribution (export) deals in Hong Kong, Mongolia, Saudi Arabia and the UAE.

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