RepliCel Life Sciences Inc (OTCMKTS:REPCF) has announced positive results from the proviosional analysis of the phase 1 trial that is studying RCS-01dor damaged and aging skin treatment. The main objective of the study is to develop a self-supporting safety portfolio for RCS-01 intradermal injections at a post-injection period of six months. Participants in the study which is being carried out in Germany did not experience any life-threatening adverse event at the trial’s interim point. The trial’s researchers also collected convincing positive-of-concept results showing skin rejuvenation potential of the product.
There were minimal chances of a statistically important result of safety and efficacy from the trial. However, the almost double increase in expression of genes related to collagen in the skin following a single dose injection of RCS-01 was very pronounced with a single RCS-01 injection raising the statistic significance of the results. The trial examined the effect of the injection on several biomarkers that are related to sun-damaged as well as aging skin. Gene expression biomarkers like metalloproteinases (TIMP) inhibitors exhibited a lot of changes attached to increase in collagen fibers. Increase in production of collagen and reduction in dehydration of collagen is correlated to reduced wrinkles as well as sun-damaged skin repair
Prof. Dr. med Jean Krutmann, from the IUF Leibniz Research Institute for Environmental Medicine which hosted the study says the positive impact on TIMP gene expression is a rare occurrence and this is an isolated finding particularly for an efficacy and safety study with a small size of the sample. He adds that the positive finding show the ability of RCS-01 to enhance the rejuvenation of the skin.
According to Krutmann repeating these findings in a bigger study will confirm the product’s ability as an alternative to Botulinum toxins and only works to temporarily reverse and prevent the aging signs.
Chief Medical Officer at RepliCel Dr. Rolf Hoffmann say the trial has indicated a perfect safety profile and offers significant proof-of-concept that RCS-01 cells are naturally good producers off collagen in the skin.