RXi Pharmaceuticals Announces the Start of Their First Phase 2 Study with RXI-109 for Treatment of Hypertrophic Scars in Conjunction with Scar Revision Surgery
WESTBOROUGH, Mass., Nov. 13, 2013 /PRNewswire/ -- RXi Pharmaceuticals Corporation (OTCQX: 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 been enrolled in a Phase 2 study with the anti-scarring product RXI-109. In this study (RXI-109-1301), patients with a long hypertrophic scar in the lower abdominal area are eligible to receive scar revision surgery and subsequent treatment with RXI-109 in one of two treatment regimens. Patients will receive RXI-109 or placebo on a blinded basis at the distal ends of their revised scar, leaving a central untreated section of the scar. Each patient's revised scar area will provide the opportunity to compare the appearance of the revised areas after treatment with RXI-109 or placebo or when left untreated. This design allows for intra-subject comparison of the three revised scar segments, as such increasing the power of the study.
"The start of the first Phase 2 clinical study with RXI-109 is a very important step in bringing our first self-delivering (sd-rxRNA®) RNAi closer to the market," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, "Not only can the outcome of this first Phase 2 study create a novel treatment approach in an area where no FDA approved drugs exist; it should also confirm the clinical relevance of our proprietary sd-rxRNA approach for human diseases in a broader sense, creating numerous business development opportunities that could add substantial value to our company."
In its public disclosures, the Company has indicated that two additional Phase 2 studies will be initiated in the near future. The first of these will evaluate the effect of RXI-109 on the recurrence of keloids after keloid revision surgery. The second study will evaluate the effect of RXI-109 on suppressing recurrence of hypertrophic scars after bilateral scar revision surgery in the breast area.
Skin scarring after surgery, trauma, or burns can cause debilitating aesthetic, functional and psychological effects. There are no FDA-approved therapeutics for treatment of post-operative scars. RXI‑109 has been shown in preclinical models to reduce CTGF, a growth factor essential in the wound healing cascade. Elevated levels of CTGF‑dependent signaling can prolong the tissue repair process and lead to pathological scarring.
RXi Pharmaceuticals' first clinical program involves RXI‑109, a self-delivering RNAi compound (sd‑rxRNA®) developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.
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.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (OTCQX: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi 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. 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, including future expectations regarding our NASDAQ listing, 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 RXI-109 and our other product 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; the possibility that other companies or organizations may assert patent rights preventing us from developing our products; risks related to our ability to successfully list our securities on a national securities exchange and statements about other future expectations. 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