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Biz News Korea(Eng)
Phase III clinical study approved to evaluate Invossa in mild knee OA patients in Korea
- Collected
- 2017.11.24
- Distributed
- 2017.11.27
- Source
- Go Direct
The company aims to expand the therapeutic window of the cell therapy to include mild patients classified by the Kellgren-Lawrence grading system and OA-related pain severity. The drug is currently indicated for the treatment of patients with moderate to severe knee OA (Grade 3) who feel pain walking on an even terrain.
Kosdaq-listed shares of Kolon Life ended Thursday 3.8 percent up at 145,300 won ($133).
There are several ways to diagnose and classify knee OA and the Kellgren-Lawrence grading scale is commonly used, which is broken up into four grades: Doubtful (Grade 1), Mild (Grade 2), Moderate (Grade 3) and Severe (Grade 4).
The planned clinical trial is designed to evaluate the efficacy and safety of the drug in patients with a KLGS of 2, who feel pain walking on a slope as the narrowing of joint space progresses.
The phase III study will last for two years from early next year involving 146 patients at 17 hospitals. Invossa is directly injected into the joint requiring no need of knee resection in patients and is proven effective for two years with one-time administration.
The therapy is the country’s first home-grown cell and gene therapy and 29th novel medicine approved by the Ministry of Food and Drug Safety.
By Kim Myung-hwan and Minu Kim
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