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TissueGene Inc.

Latest From TissueGene Inc.

A Glimpse Of Light For Kolon As US Invossa Trials To Resume

Following the long-awaited decision from the US FDA, Kolon TissueGene will resume Phase III clinical trials of the cell and gene therapy for degenerative osteoarthritis TG-C (Invossa) in the US this year.

South Korea Clinical Trials

Kolon TissueGene Faces Delisting In Korea On Invossa Uncertainties

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 Gene Therapy

Korea Suspends First Approved Gene Therapy Pending Component Discrepancy Probe

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.

South Korea United States

Disease Modifying Status Targeted As Kolon's Novel OA Therapy Enters US Phase III

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.

Clinical Trials Biologics
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Company Information

  • Industry
  • Biotechnology
    • Gene Therapy, Cell Therapy
  • Pharmaceuticals
  • Therapeutic Areas
  • Musculoskeletal & Connective Tissue Disorders
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • TissueGene Inc.
  • Senior Management
  • Kwan H Lee, MD, PhD, CEO
    Moon Soo Song, CFO
    J. Kelly Ganjei , Dir., Bus. Dev.
  • Contact Info
  • TissueGene Inc.
    Phone: (301) 921-6000
    209 Perry Pkwy., Ste. 13
    Gaithersburg, MD 20877