RXi Pharma Reports Start Of First Phase 2 Trial With RXI-109 - Quick Facts

(RTTNews) - RXi Pharmaceuticals Corp. (RXII) announced the enrollment of the first patient in a Phase 2 study with the anti-scarring product RXI-109. In this trial, 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.

The company said the patients would 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 would 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 trial.

Commenting on the trial, President and CEO of RXi Pharmaceuticals said: "Not only can the outcome of this first Phase 2 study create a novel treatment approach in an area where no FDA approved drugs exist; it should also confirm the clinical relevance of our proprietary sd-rxRNA approach for human diseases in a broader sense, creating numerous business development opportunities that could add substantial value to our company."

The firm, in its public disclosures, has indicated that two additional Phase 2 studies would be initiated in the near future. Of these, the first would assess the effect of RXI-109 on the recurrence of keloids after keloid revision surgery, while the second study would evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.