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Kolon Group Receives FDA Approval for Phase 3 Clinical Trials of Invossa
Knee Medicine
Kolon Group Receives FDA Approval for Phase 3 Clinical Trials of Invossa
  • By Jung Min-hee
  • May 19, 2015, 09:15
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Invossa made by the Kolon Group (Chairman Lee Woong-yeul), the world’s first allogeneic cell therapy for osteoarthritis of the knee, will start Phase 3 clinical trials by the U.S. Food and Drug Administration (FDA). A cell therapy product for degenerative arthritis, it is the first treatment to enter Phase 3 clinical trials in the world.

Invossa is the official brand name of the new drug, which was known as TissueGene-C (TG-C) before. It is named in accordance with the naming guidance for new drugs of the U.S. FDA. Invossa is a contraction of “Innovative Arthritis Drug.”

On May 15, TissueGene, Inc., Kolon Group’s subsidiary in the U.S., ended a Special Protocol Assessment (SPA) and determined to enter Phase 3 clinical trials.

The SPA measures the possibility of failure due to the incorrect design of clinical trials by having prior consultation with the U.S. FDA on the plan for Phase 3 clinical trials, including evaluation index and statistical significance test.

This double-blinded randomized controlled trial will involve approximately 1,020 patients with osteoarthritis of the knee in the U.S. Patients will receive an injection of either Invossa or a placebo. The trial is designed to evaluate improvement in knee function and pain and therapeutic efficacy as measured by joint space width. The company plans to use data from the trial as the basis for the submission of a Biologics License Application (BLA) for Invossa.

If it passes, Invossa will be the first disease-modifying osteoarthritis drug (DMOAD) marketed for the treatment of osteoarthritis of the knee in the world.

Lee Woo-sok, President and CEO of Kolon Life Science Inc. and TissueGene, Inc., said, “We are happy to receive the approval for the Phase 3 clinical trial of Invossa from the U.S. FDA. We will successfully initiate this trial as soon as possible so we can help 150 million patients suffering from degenerative arthritis all over the world.”

Kolon Life Science is currently conducting the local trial on 156 patients in 12 university hospitals including Seoul National University Hospital, Samsung Medical Center Seoul, and ASAN Medical Center. It plans to complete the trial in July this year and to apply for Korean Food and Drugs Administration approval for the item within this year. President Lee said, “Starting with the commercialization of Invossa in Korea some time next year, we look forward to its expansion in the Asian market and full-fledged growth.”

Invossa is a gene therapy to treat osteoarthritis of the knee by simply injecting healthy human allogeneic cartilage cells and cells with a growth factor promoting cell differentiation on the glenoid cavity of the knee. It is possible to mass produce these cells, so the medicine will be an innovative treatment that can respond to the massive demand in time.