News Column

RXi Pharmaceuticals Announces Initiation of Phase 2a Keloid Study

May 12, 2014



By a News Reporter-Staff News Editor at Pharma Business Week -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, announced that the first patient has enrolled in their Phase 2a study (RXI-109-1401) with RXI-109 for the prevention of keloid recurrence. RXI-109 is an sd-rxRNA compound that targets connective tissue growth factor (CTGF) and is being developed for the treatment of abnormal dermal scars, such as hypertrophic scars and keloids, in conjunction with scar or keloid revision surgery. Phase 1 studies have shown that RXI-109 is safe and well tolerated. In addition, RXI-109 was shown to reduce CTGF mRNA in line with its mechanism of action by up to 50% in healthy volunteers with the doses tested. Excessive production of CTGF is considered a major cause of abnormal scarring, such as hypertrophic scars and keloids (see also RXi Pharmaceuticals Corporation).

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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. Pamela Pavco, Chief Development Officer of RXi Pharmaceuticals. She added that, "Being able to demonstrate clinically relevant differences between RXI-109 and placebo could constitute a major milestone in the treatment of keloids, since to date, no drugs for treatment of keloids have been approved by the FDA."

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.

Keywords for this news article include: RXi Pharmaceuticals Corporation, Surgery.

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Source: Pharma Business Week


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