On November 21, 2018, BioLife’s customer Kolon TissueGene, Inc., a leader in advanced cell and gene therapies, announced that it has dosed its first patient in its pivotal US Phase III clinical trials for Invossa, a cell and gene therapy in development for knee osteoarthritis (OA).
‘This is an exciting step for Kolon TissueGene as we progress towards providing key clinical benefits for patients of this debilitating disease with this novel cell and gene therapy for knee osteoarthritis,’ stated Mr. Woosok Lee, President and CEO of Kolon TissueGene.
Kolon TissueGene is conducting pivotal Phase III trials for US approval of Invossa for knee osteoarthritis. The pivotal phase III trials for US approval of Invossa will enroll close to 1,020 patients in approximately 60 clinical sites across the United States. The trial investigators include orthopedic surgeons, rheumatologists and pain specialists. During the trial, the company will assess pain and function endpoints as well as MRI, X-Ray and liquid biomarkers.
In addition to demonstrating significant improvements in pain relief and function, the trials are designed to show structural benefits, including a delay in disease progression, and if successful could achieve a Disease Modifying Osteoarthritis Drug or ‘DMOAD’ label claim. Such an indication by the FDA would be a first for any osteoarthritis drug approved in the US.
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