Latest From TissueGene Inc.
Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.
South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.
With the removal of an FDA clinical hold, Kolon TissueGene is set to begin a US Phase III trial for Invossa, its first-in-class cell and gene therapy, for osteoarthritis of the knee. The planned study, which is larger and longer than the product's Korean Phase III program, will be under the spotlight as it will determine whether Invossa can be designated as the world's first disease-modifying drug in osteoarthritis, and is being designed accordingly.
2017 was the second-best year for new drug launches worldwide since the start of the millennium, new research by Informa Pharma Intelligence's Pharmaprojects has found.
- Gene Therapy, Cell Therapy
- Therapeutic Areas
- Musculoskeletal & Connective Tissue Disorders
- North America
- Parent & Subsidiaries
- TissueGene Inc.
- Senior Management
Kwan H Lee, MD, PhD, CEO
Moon Soo Song, CFO
J. Kelly Ganjei , Dir., Bus. Dev.
- Contact Info
Phone: (301) 921-6000
209 Perry Pkwy., Ste. 13
Gaithersburg, MD 20877
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