- ‘TPX-105,’ if approved, is world’s 2nd wrinkle-improving cell therapy product
“TPX-105,” a wrinkle-improving cell therapy product developed by Tego Science, has shown excellent effects with just a single administration, raising hopes for its market release, the company said Wednesday.
TPX-105 is an autochthonous skin cell treatment using the cells of patients. In February, the drug applied to the Ministry of Food and Drug Safety for its permission and review is under way. The target disease is the improvement of the “non-coarse corrugation,” or bags under eyes.
If approved, the drug will be the second wrinkle-improving cell therapy product in the world, and the first one for curing under-eye folds, it said.
As it is a self-derived cell therapy, there is no immunity rejection or side effects, and users can expect long-term therapeutic effects.
Tego Science, a company specializing in developing cell therapy products, collaborated with two large hospitals to conduct clinical trials – manifold, randomized, independently assessed, blind, placebo-controlled tests -- on 46 adults showing severe symptoms of under-eye bags, from December 2015 to October 2016.
After injecting a shot of TPX-105, the researchers waited for 24 weeks and found improvement in 76 percent of the experimental group administered with the drug. On the other hand, none of the patients in the placebo-treated control group showed wrinkle-improving effects.
Statistical analysis showed the two groups showed a significant difference in wrinkle improvement, proving great effects of TPX-105, the company said.
That compares with a competing product – LaViv released by Fibrocel, a U.S. company – which showed the wrinkle-improving rate of 20-40 after three times of administering, it said.
Tego Science plans to step up efforts to commercialize TPX-105, by replenishing production capacity at its research and development center, whose construction is under way for completion in the latter half of this year and securing distribution network, a company spokesman said.