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RXi Begins Scar Correction Trial

Self-delivering RNAi compound to test against abdominal scarring

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

RXi Pharmaceuticals has enrolled the first patient in its Phase II study of the anti-scarring product RXI-109. In this study, patients with a long hypertrophic scar in the lower abdominal area are eligible to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. Patients will receive RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar. Each patient’s revised scar area will provide the opportunity to compare the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated. This design allows for intra-subject comparison of the three revised scar segments, as such increasing the power of the study.

Two additional Phase II studies will be initiated in the near future. The first of these will evaluate the effect of RXI-109 on the recurrence of keloids after keloid revision surgery. The second study will evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.

RXI‑109 is a self-delivering RNAi compound developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.

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