RXi Pharmaceuticals Announces Initiation of Phase 2a Keloid Study
MARLBOROUGH, Mass., April 29, 2014 /PRNewswire/ -- 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, today 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.
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. Today's 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.
About Hypertrophic Scars and Keloids
Hypertrophic scars are abnormal scars that are raised above the normal skin surface and can be reddened or darker than the existing skin tone. These scars result in part from an increased level of collagen and are less "elastic" than the surrounding skin. Hypertrophic scars remain confined to the original surgical incision line or site of injury. The incidence of hypertrophic scarring (raised, thickened scars) following surgery is reported to be at least 40% in the general population and up to 70% in certain Asian populations.
Keloids are also raised and reddened or darkened scars resulting from increased collagen production, but keloids often spread beyond the original site of skin injury and may continue to grow in size. Keloids can result from skin "trauma" as common as an ear piercing or vaccination and may grow to cover large areas. Keloids are sometimes removed by surgical revision, but recurrence rates are as high as 50-80%. Keloids are most prevalent in darker skinned individuals, up to 16% in people of African ancestry, and 50% of all keloid patients have a family history of keloids.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi (sd-rxRNA®) platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to down-regulate the expression of a specific gene that may be over-expressed in a disease condition. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the RXi Scientific Advisory Board, RXi's first RNAi product candidate, RXI‑109, targets connective tissue growth factor (CTGF) to reduce dermal scarring (fibrosis), entered into human clinical trials in June 2012.
RXi's sd‑rxRNA oligonucleotides are designed for therapeutic use and have drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. These hybrid oligonucleotide molecules combine the beneficial properties of conventional RNAi and antisense technologies. This allows sd‑rxRNAs to achieve efficient cellular uptake and potent, long-lasting intracellular activity.
RXi Pharmaceuticals' first clinical program involves RXI‑109, an sd-rxRNA compound, developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of connective tissue growth factor (CTGF), a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials with RXI‑109 showed excellent safety and tolerability with ascending single and multiple doses, as well as dose dependent effects on the CTGF protein and on the mRNA that controls production of this protein. For more information, please visit www.rxipharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, planned and future development of RXi Pharmaceuticals Corporation's products and technologies. Forward-looking statements about expectations and development plans of RXi's products involve significant risks and uncertainties: risks that RXi may not be able to successfully develop its candidates, or that development of RNAi-based therapeutics may be delayed or not proceed as planned, or that we may not develop any RNAi-based product; risks that the development process for our product candidates may be delayed; risks related to development and commercialization of products by our competitors; risks related to our ability to control timing and terms of collaborations with third parties; and the possibility that other companies or organizations may assert patent rights preventing us from developing our products. Actual results may differ from those contemplated by these forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
RXi Pharmaceuticals Corporation
Tamara McGrillen, 508-929-3646
SOURCE RXi Pharmaceuticals Corporation