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RXi Pharmaceuticals Corporation (OTC: RXII), today announced that dosing with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids has been initiated. Nine subjects (3 cohorts of 3) are participating in this dose escalation study during which intradermal injections of RXI-109 will be administered on 3 occasions over 2 weeks. Dose levels range from 2.5 to 7.5 mg per injection, and subjects will receive injections of RXI-109 and vehicle at small incisions on separate areas of their abdomen. Data on safety and tolerance will be collected and evaluated. The incisions will also be evaluated for possible drug effects on the scarring.
“We are pleased that, based on the excellent safety profile observed after single dosing with RXI-109, we have been able to move this quickly from the first into the second clinical study, which evaluates multiple doses per subject,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “The speed with which we have been able to move this development forward is a testament to the safety of the drug, but also to the dedication of the team that executes this project. If we can continue at this pace, and assuming no unexpected hurdles, RXi Pharmaceuticals should be able to move into its first Phase 2 studies with RXI-109 in the second half of 2013.”
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI-109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF-dependent signaling can prolong the tissue repair process and lead to pathological scarring.
RXi Pharmaceuticals’ first clinical program involves RXI-109, a self-delivering RNAi compound (sd-rxRNA®) 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 trial of RXI-109 has shown excellent safety and tolerability with ascending single doses. This second trial uses multiple doses and evaluates safety and side effects of these doses, while also exploring possible effects of RXI-109 on the healing process.