RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that dosing with their first drug in its first Phase 1 study, was completed last week. RXI-109 is being developed to prevent or reduce dermal scarring following surgery or trauma, as well as for the management of hypertrophic scars and keloids. Over the past 3 months, 15 subjects who are scheduled to undergo abdominoplasty in the coming months, were enrolled in a double-blind dose, escalation study during which single intradermal injections were administered in a dose dependent manner to 5 cohorts of 3 subjects each. Subjects received an injection of RXI-109 in 2 separate areas on the abdomen and placebo injections in two other areas of the abdomen. Data on safety and tolerance were collected and evaluated for each cohort before moving to the next cohort with a higher dose level.
RXI-109 was well tolerated by intradermal injection. No serious local or systemic side effects were observed in the subjects at any of the doses administered. Local erythema (redness) around the injection site was somewhat more pronounced in the cohort that received the highest dose, but these instances of redness disappeared usually within 72 hours after the injection, and did not give rise to significant subjective complaints from the study subjects.
“These are exciting times for RXi Pharmaceuticals,” said Dr. Geert Cauwenbergh, President and CEO of the company. “These results show that sd-rxRNA, as a technology, can be used locally over a range of concentrations in a safe and well-tolerated manner. In the past, concerns have been raised over the tolerability of RNAi compounds in clinical trials for systemic organ diseases. These clinical data in skin and dermis confirm our earlier observations in animal studies that RXi’s self delivering (sd) technology can be used safely for disease indications where local delivery is appropriate.” Dr Cauwenbergh added that, “the subjects continue to be followed with photographic documentation of their incision sites for a direct visual comparison, and biopsies of these sites at the time of the scheduled abdominoplasties, will allow direct comparison of RXI-109 versus placebo treated sites on a histological level. We are looking forward to these data becoming available in the coming months.”