RXi Pharmaceuticals Announces Positive Data in Second Phase 1 Multi-Dose Study Data from RXi's Phase 1 studies, as well as plans for RXI-109 development and other potential therapeutic applications, will be discussed during the Company's Investor & Analyst Symposium that will be webcast today.
WESTBOROUGH, Mass., July 12, 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 positive results from their second placebo-controlled Phase 1 study with RXI‑109, 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 revision surgery.
In this study, subjects received small skin incisions in their abdomen and were treated with 3 intradermal doses of RXI‑109 over a 2-week period. This dose escalating study consisted of 3 cohorts of 3 healthy volunteers each. Subjects received RXI‑109 on one side of the abdomen, and placebo on the other side. Subjects were monitored for safety and local and systemic side effects over a total study period of 84 days. Multiple dermal injections were well tolerated at all doses, and treatment with RXI‑109 resulted in dose-dependent silencing of CTGF mRNA in the treated areas.
Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals said that, "We are very pleased with the outcome of this second Phase 1 study. These results show that multiple intradermal injections of RXI‑109 are well tolerated with minimal and mild side effects. He added that, "The work done in the last year has confirmed that our proprietary self-delivering RNAi technology (sd-rxRNA) reduces CTGF mRNA in humans in line with its mechanism of action. Indeed, results from this second study demonstrate that mRNA for CTGF in the incisions is reduced in a dose-dependent manner by RXI‑109 as compared to placebo. Our first Phase 1 study had already shown that a single dose of the drug lowered the actual protein content for CTGF also in a dose-dependent manner. With this exciting outcome, we are ready to embark on Phase 2 development in patients with hypertrophic scars and keloids."
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (OTC: 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, 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.
SOURCE RXi Pharmaceuticals Corporation