TissueGene gets go-ahead for Ph IIa OA trial

The USA's TissueGene and its South Korean licensing partner Kolon Life Science have received regulatory allowance from the Korean Food and Drug  Administration to initiate a Phase IIa trial of TissueGene-C in patients  with severe osteoarthritis of the knee.

The Phase IIa clinical trial is designed as a randomized, multicenter  study to evaluate the safety and efficacy of TG-C in patients with Grade  IV Degenerative Joint Disease of the knee who have been unresponsive to  existing therapies. The patients will receive an intra-articular  injection to the damaged joint area at one of two dose levels. The  primary endpoint of the trial will be evidence of symptomatic  improvement and the secondary endpoint will be a sign of cartilage  regeneration through MRI evaluation.

"The launch of this Phase II study represents a critical step in the  development of a commercially- and clinically-viable mechanism to  initiate regeneration of cartilage for patients suffering from  osteoarthritis," said chief executive Kwan Hee Lee.