WESTBOROUGH, Mass.--(BUSINESS WIRE)--RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that its second Phase 1 study with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids, has been fully enrolled. This multi-dose study administers 3 intra-dermal injections over a two week period, in a dose ascending manner, with each subject receiving both active and placebo on a double blind basis. This second study not only evaluates safety/tolerance parameters and systemic exposure to the drug but also measures mRNA levels of CTGF and various other biomarkers considered relevant for wound healing and scarring.
“The completion of enrollment for this study has happened well within the projected time frame”
“The completion of enrollment for this study has happened well within the projected time frame,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “The safety profile of RXI-109, continues to be excellent, and the Company hopes to extract valuable information from these studies that will contribute to the design of our Phases 2a studies in terms of dose and treatment frequency.”
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 trial of RXI-109 has shown excellent safety and tolerability with ascending single doses. This second trial uses multiple doses and evaluates safety and side effects of these doses, while also exploring possible effects of RXI-109 on the healing process.
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 (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, which targets CTGF, entered into human clinical development 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.