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U.S. FDA okays TissuGene to continue with phase 3 clinical trial on Invossa

2018.07.06 13:35:43 | 2018.08.02 09:29:33
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Kolon TissueGene, the biotech unit of Korea’s pharmaceutical firm Kolon Life Science, said on Friday the U.S. Food and Drug Administration (FDA) has removed clinical hold on phase 3 clinical trial of its investigational osteoarthritis drug Invossa.

Kolon TissueGene shares soared nearly 10 percent in early morning trade on the news but ended the day 0.77 percent lower at 38,600 won.

The company said it will soon begin an enrollment process for the clinical trial to evaluate the drug’s efficacy on about 1,020 patients at more than 50 sites across the U.S.

The company has prepared sample agents to meet FDA requirements for the study whose basic design was approved by the health regulator in May 2015.

The phase 3 trial was designed to assess the drug’s ability to reduce pain and improve physical functions in patients with osteoarthritis and whether Invossa can be a disease-modifying osteoarthritis drug (DMOAD), which inhibits structural disease progression and ideally also improves symptoms. Currently, there is no approved DMOAD in the world.

By Shin Chan-ok and Minu Kim

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]



  • Seoul Tue 25 September 2018
  • TUE


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