Late last year the Company started its first Phase 2a study (RXI-109-1301) in patients who had pre-existing hypertrophic scars present on their lower abdomen for at least one year. In that study, the patients undergo scar revision surgery, after which they are treated with RXI-109 on one end of the scar and placebo on the opposite end of the scar. The announcement relates to the Company's second Phase 2a study (RXI-109-1401) for RXI-109 treatment to prevent recurrence of keloids in patients undergoing keloidectomy (removal of keloid). In this study, patients with two keloids of similar size and location are selected for keloidectomy. After this procedure, the lesions are closed and one is treated with RXI-109, and the other is treated with placebo. As is the case for the study in hypertrophic scars, patients will be followed for several months (clinically and with photographs) after the end of treatment.
"This is the first time that an RNA interference compound targeting CTGF will be studied to reduce the recurrence of keloids after excision surgery," said Dr.
This second Phase 2a study will follow patients for six months to evaluate the clinical evolution of the lesions which, in these patients, have a high risk for recurrence of keloids. The Company expects to get an early first impression of a possible clinical effect of RXI-109 after a keloidectomy before the end of this year.
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