The US Food and Drug Administration allows the resumption of the phase 3 clinical trial.

The US Food and Drug Administration allows the resumption of the phase 3 clinical trial for Invossa in the US.

▷ KOLON TissueGene receives an official notice from the FDA lifting the clinical hold on the phase 3 trial for Invossa, a gene therapy for osteoarthritis, in the US.

▷ The FDA says that all clinical hold issues related to Invossa have been resolved to satisfaction.

▷ The phase 3 clinical trial is set to resume with the transformed kidney-derived cell (second fluid of Invossa).

▷ The FDA recognizes the validity of data of all previous clinical trials for Invossa.

On April 11 (Korean local time), the FDA of the US officially allowed the resumption of the phase 3 clinical trial (patient administration) for Invossa, a cell-and-gene therapy for osteoarthritis currently being developed by KOLON TissueGene, by removing a clinical hold that had been in place.

In its official notice to KOLON TissueGene lifting the clinical hold and dated April 11, the FDA stated, “All clinical hold-related issues of Invossa have been resolved to satisfaction. We lifted the clinical hold, and KOLON TissueGene is now free to perform the clinical trial for Invossa.”

KOLON TissueGene may now resume the Invossa clinical trial after 11 months since the FDA decided to impose the clinical hold in May last year.

This means that the FDA has recognized the validity of the clinical trial data submitted previously by KOLON TissueGene and allowed the resumption of the phase 3 clinical trial, including patient administration, with the transformed kidney-derived cell (second fluid).

On May 3 of last year, the FDA decided to impose a clinical hold on the phase 3 clinical trial for Invossa in the US and requested the submission of the analysis of ingredients and their traits, the background of the change of ingredients, and follow-up measures. On September 20, the FDA additionally requested the submission of complementary data for the materials previously submitted. KOLON TissueGene has been continually exploring the possibility of the resumption of the clinical trial by submitting the required data and discussing the matter with the FDA.

The FDA requested additional data on the improvement measures for the manufacturing process of Invossa specified in the annual report and the stability of the clinical sample in the notice. A KOLON TissueGene staff member said, “This request is unrelated to the removal of the clinical hold and can be easily handled.”

KOLON TissueGene plans to carry out the clinical trial and administer Invossa to patients as soon as updates on the clinical trial plan and the clinical trial patient consent form are made as discussed with the FDA.

A KOLON TissueGene staff member said, “We will thoroughly perform the phase 3 clinical trial in the US to prove the value of Invossa as the world’s first cell-and-gene therapy for osteoarthritis.”

Invossa’s cell-and-gene therapy for osteoarthritis is a combination of cartilage cells extracted from human cartilage (first fluid of HC) and transformed cells with TGF-β1 (second fluid of TC) by the ratio of 3:1. It is injected into the glenoid cavity.