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Novel intra-articular gene therapy improves function, pain in knee OA

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LIVERPOOL, England — A novel intra-articular injection of allogeneic gene-modified cell therapy was associated with significant improvements in International Knee Documentation Committee scores compared with placebo, according to findings presented here.

Bumsup Lee, PhD, president and CEO of TissueGene Inc., presented findings for the Invossa-k (Kolon TissueGene) injection for the treatment of knee OA. The injection is approved in Korea and is in phase 3 trials in the US. “We make one single injection into the intra-articular joint,” he said.

In the current study, 78 patients were given the injection at a dose of 1.8 X 10⁷ cells in the knee (3.0 mL) and 81 patients received placebo. Participants were observed for 1 year. Lee presented data for both 1-year and 3-years’ follow-up. International Knee Documentation Committee (IKDC) score and scores from the 100-point VAS scale at 52 weeks served as the primary endpoints.

The final analysis included 74 patients in the active therapy group, and 76 in the placebo group.

Results showed Invossa-k was associated with an improvement in IKDC score of 15.1 through 12 months, compared with an improvement of five for placebo.

“VAS also showed statistically significant improvement for Invossa-k over placebo,” Lee said. “It maintained its improvement over 3 years.”

Lee reported a responder rate of 84% for the study drug and 45% for placebo.

Other findings indicated non-significant differences between the two study arms in terms of bone area change and cartilage thickness at 12 months.

Also at 1 year, WOMAC scores changed by -13.9 for the active therapy group and -6.2 for placebo. By 3 years, WOMAC score changed by -17.4 for patients in the Invossa-k group.

Serum biomarker CTX-1 and CTX-2 levels were “consistently and steadily” reduced by the study drug over the first year, according to Lee. He added that the active treatment arm also improved over placebo in terms of JSW evaluation (P = .08).

One patient in the active therapy group and six patients in the placebo group required TKA surgery at 3 years, according to Lee.

Safety data showed joint swelling and arthralgia in the Invossa-k group. No serious adverse events were reported.

“Invossa-k was associated with statistically and clinically significant improvements in function and pain,” Lee concluded. “It shows great potential for a DMOAD drug going to market for the first time.”– by Rob Volansky

Reference:

Lee BB. Abstract #66. Presented at: OARSI 2018 World Congress on Osteoarthritis; April 26-29, 2018; Liverpool, England.

Disclosure: Lee is president and CEO of TissueGene, Inc.