Invossa Phase 3 trials to resume in U.S. as FDA green-lights

Kolon TissueGene has been granted approval by the U.S. Food and Drug Administration (FDA) to resume Phase 3 clinical trials for Invossa, a gene therapy off the shelves and in limbo since early last year.

The U.S. subsidiary of Kolon Life Science said Sunday that it received a letter from the U.S. regulator on Saturday informing it that a hold on Invossa’s Phase 3 clinical trials had been removed. With the letter, Kolon TissueGene will be able to resume trials that have been frozen since last May.

Kolon TissueGene said the letter indicates that the FDA acknowledged the viability of clinical trial data from the past. In September, the FDA asked for supplementary data for Kolon TissueGene to resume trials.

In its letter, the FDA requested the company improve the manufacturing process for Invossa and asked for data on the to-be-resumed clinical trial.

Kolon TissueGene plans to kick off the Phase 3 clinical trial restart after finishing discussions with the FDA on the additional requests.

Clinical trial resumption could be a big win for Kolon TissueGene and its parent company as the fortunes of both were highly dependent on Invossa.

Kolon TissueGene is fighting possible delisting from the Kosdaq.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]