The company has been awarded a $750,000 clinical grant from Maryland Technology Development Corp. via the Maryland Stem Cell Research Fund.
The new grant will be used by TissueGene to fund a portion of its US-based phase three clinical trials for Invossa. The clinical study aims to verify that the drug not only enables tissue regeneration but also treats other inflammatory conditions such as synovitis.
The drugmaker plans to start phase three clinical trials of Invossa in the US by the first half of next year. The clinical study, which is to go on for two years, will involve 1,020 patients and take place at 50-70 locations in the US, the firm said.
TissueGene is planning to go public on Korea’s secondary bourse Kosdaq by November. It is offering 1.5 million new shares for sale at an indicative price range of 16,000 won ($14) to 27,000 won in order to raise between 120 billion won to 202.5 billion won.
The firm developed Invossa, a first-in-class drug that treats osteoarthritis of the knee through a single intra-articular injection. It is a cell-mediated gene therapy, which involves inserting normal genes in place of missing or defective ones into a patient’s cell to treat a disease.
Invossa was approved by the Korean Ministry of Food and Drug Safety in July. However, it was approved only for pain relief and function improvement, limiting the drug’s therapeutic boundaries.
The cell gene drug has been widely expected to offer breakthrough improvements in joint structure by regenerating damaged cartilage. It is a core therapeutic benefit that Kolon has stressed for Invossa as well.
The Kolon-owned drug developer has stated that it will prove Invossa’s therapeutic efficacy in joint improvement, including joint regeneration, through its upcoming phase three clinical trials in the US.
By Sohn Ji-young (email@example.com)