Juniper Biologics has obtained the licensing rights for the development and commercialisation of Kolon Life Science ’s cell-mediated gene therapy, TissueGene-C low dose (TG-C LD), to treat knee osteoarthritis.
A non-surgical investigational therapy, TG-C LD is claimed to be the first in the world to potentially treat knee osteoarthritis, which is a common form of arthritis.
It is administered as a single intra-articular injection.
Under the $600m licencing deal, Juniper will develop and market the gene therapy to medical professionals and hospitals in the Asia Pacific, the Middle East and Africa.
Furthermore, Kolon will extend support for the gene therapy development and supply.
TG-C’s licence holder in the US, Kolon TissueGene, has concluded a Phase II clinical trial in the country.
Preliminary findings from the trial showed that a single injection of TG-C in the knee joint offered lasting pain relief and improvement in mobility for possibly up to two years.
Phase III trials enrolling 1,020 patients in the US are currently underway to validate the safety and efficacy of TG-C.
Apart from establishing the statistically significant decline in pain and function improvements reported in the US Phase II trial, these trials are intended to demonstrate the delay of disease progression to obtain a Disease-Modifying Osteoarthritis Drug designation.
Juniper Biologics CEO Raman Singh said: “We are always looking to identify areas in which we can make the most difference and TG-C LD offers substantial relief for knee osteoarthritis patients who would otherwise be in need of surgery or other treatment options.
“We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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