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RXi Pharmaceuticals Expands Clinical Program with Initiation of Third Phase 2a Study with RXI-109 for Treatment of Hypertrophic Scars

Companies mentioned in this article: RXi Pharmaceuticals Corporation

MARLBOROUGH, Mass., July 30, 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 their third Phase 2a study (RXI-109-1402) with RXI-109, for the reduction of recurrence of hypertrophic scars following elective scar revision surgery, has been initiated.

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In this study (RXI-109-1402), patients with either one long hypertrophic scar, or two scars comparable in length, anatomical location and characteristics, are eligible to receive scar revision surgery. For a single scar, a portion of the revised scar segment will be treated with RXI-109 and a comparably sized length on the opposite end of the excised scar segment will be left untreated. If two scars are revised, a portion of one revised scar segment will be treated with RXI-109 and one scar will be left untreated after revision surgery.

"The Company continues to deliver against its projected corporate milestones with the initiation of this third study," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, "This study is another step forward to bringing our self-delivering (sd-rxRNA(®)) RNAi technology closer to market. We are very excited by everything we have been able to achieve with our compounds, thus far, and we look forward to providing further updates in the near future."

This third Phase 2a study will follow patients for nine months. Investigator and independent reviewer assessments will be used to evaluate the effectiveness of RXI-109 in preventing scar formation. Reviewers will evaluate and compare the appearance of the revised areas after treatment with RXI-109 or when left untreated. This design allows for intra-subject comparison thereby increasing the power of the study.

About RXI-109 Clinical Trials

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 (RXI-109-1201 and RXI-109-1202) 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.

In November 2013, 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. In April of this year, the Company began its second Phase 2a study (RXI-109-1401) for RXI-109 treatment to prevent recurrence of keloids in patients undergoing keloidectomy (removal of keloid). Patients in that study, who have 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.

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 specific genes that may be over-expressed in disease conditions. 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, a self-delivering RNAi compound (sd-rxRNA(®)), entered into human clinical trials in June 2012 and is currently being evaluated in Phase 2 clinical trials to reduce dermal scarring (fibrosis). 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. 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. For more information, please visit www.rxipharma.com.

Forward-Looking Statements

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: the risk that we may not be able to successfully develop our 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 products; risks that the development process for our product candidates may be delayed, risks related to the development and commercialization of products by our competitors, the risk related to our ability to control the 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.

Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com

SOURCE RXi Pharmaceuticals Corporation