Clinical Trial of ‘Invossa’
Kolon Life Science is striving to penetrate the U.S. market with its gene therapy product Invossa. The company is currently preparing a clinical trial so that its cartilage regeneration effect can be acknowledged by the U.S. FDA.
The upcoming trial focuses on knee cartilage regeneration and the subjects include mild cases as well as serious cases. “Cartilage regeneration tends to be more active in mild cases than in serious cases and, as such, we are expecting that the result of the upcoming third clinical phase in the United States will be better than that of the previous clinical trial in South Korea,” the company mentioned. The previous trial covered only serious cases before the first gene therapy product in South Korea was approved in the same country.
Kolon Life Science is planning to adopt various methods, such as biomarkers as well as joint space width measurement, for regeneration effect measurement. Earlier, the South Korean Ministry of Food & Drug Safety denied the product’s cartilage regeneration effect based on its joint space width measurement. “These days, pain reduction based on the extension of a non-cartilage tissue is increasingly regarded as cartilage regeneration,” the company explained, adding, “We are planning to conduct regular MRI analysis, not to mention X-ray, in order to observe changes in muscles and tissues.”
The biomarkers are expected to enable the company to observe the regeneration continuously for 24 months. “If a patient being treated with the Invossa shows a significant decrease in cartilage crumbling, it can be said that the medicine is effective for cartilage regeneration,” it went on to say. The third clinical phase continues from April 2018 to June 2021 and a total of 1,020 patients are scheduled to take part in it.