RXI-109 use after scar revision surgery has beneficial effect on suppression of hypertrophic scarring

RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company that owns a broad intellectual property portfolio including a unique self-delivering RNAi platform, today announced that results from a blinded panel and an Investigator review show that incision sites treated with RXI-109 after scar revision surgery achieved better scores as compared to control incision sites in the same subjects, three months post scar revision surgery.

"The use of RXI-109 after scar revision surgery has a visible, beneficial effect on suppression of hypertrophic scarring as compared with untreated control scars, at three months following surgery," said Dr. Joseph P. Hunstad, FACS, Founder of The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa, one of the Principal Investigators in this RXI-109 study.

In the first two arms of this ongoing Phase 2a study, subjects were given six intradermal injections of RXI-109, either at 5 mg/cm or 10 mg/cm, beginning two weeks after scar revision surgery, with the last of the six doses administered three months post revision surgery. Subjects had one portion of the revised scar treated with RXI-109, whereas another part of the scar was revised but left untreated. This 3-month analysis included 16 subjects of which 15 were evaluable and 1 was lost to follow-up. Of those 15 subjects, eight were treated with 5 mg/cm of RXI-109 and seven were treated with 10 mg/cm of RXI-109. All subjects were assessed using four different evaluation methods:

- POSAS (Physician and Observer Scar Assessment Scale): A compiled score based on investigator assessments of factors contributing to scar quality. These scores are provided by the investigators for both the treated and the untreated portion of the scar of their individual subjects in person;

- VAS (Visual Analogue Scale): A score based on a 10 point scale ranging from "1" (fine line scar) to "10" (worst scar possible) provided by the investigators for their individual subjects;

- A blinded assessment of photographs of the revision sites for 15 subjects by Investigators in which the clinicians were asked to indicate for Scars A and B as to which is 'better' or 'not different';

- A separate assessment of photographs of the revision sites for 15 subjects by a blinded panel, separate from the Investigators, in which the panel members were asked to indicate for Scars A and B as to which is 'better' or 'not different' .

Overall, the RXI-109 treated revision sites were scored statistically significantly better than the untreated revision sites in all four evaluations. Both dose levels of RXI-109 were equally well tolerated with occasional transient redness and itching occurring in both dose levels. Moreover, the higher dose of 10 mg/cm did not appear to add clinical benefit over the 5 mg/cm dose, leading to the conclusion that the next cohorts in this ongoing RXI-109-1402 study will be treated with the 5 mg/cm dose. These subsequent cohorts will include evaluation of additional treatments through six months to further define the optimum treatment regimen.

"We are very pleased with the outcome of the 3-month evaluation of our ongoing Phase 2a study with RXI-109 for the treatment of hypertrophic scars following scar revision surgery," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added, "Not only do these four different evaluation methods confirm the same positive conclusion, the results also bring us another step closer to identifying the final treatment schedule for RXI-109 in the management of surgical incision sites in subjects prone to hypertrophic scarring. Our continued clinical development will now focus on identifying the optimum treatment length using the 5 mg/cm dose".