RXi Pharmaceuticals Receives FDA Clearance To Begin Clinical Trial With RXI-109
RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that it has received clearance for its investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA) to initiate clinical trials with RXI-109, a self-delivering RNAi compound that selectively targets Connective Tissue Growth Factor (CTGF). The Phase 1 trial will investigate the compound in subjects to evaluate its safety and tolerability, and to look for surrogate parameters that might predict the potential of the compound to reduce dermal scarring in planned surgeries.
This is the first time that a self-delivering RNAi technology will be tested in humans. This proprietary technology is expected to reduce the issues with tissue delivery that have traditionally plagued RNAi applications since they were introduced to medicinal biotechnology over 5 years ago.
“RXi’s next generation RNAi platform has shown great promise” stated Dr. Cauwenbergh, President and CEO of RXI Pharmaceuticals. “In a short period of time, the company has been able to advance its lead product candidate for dermal scarring, RXI-109, into human clinical trials. As we aggressively pursue the potential of this compound for this condition with major social impact, we will also continue to work to create long-term shareholder value through the advancement of RXi’s robust IP platform, based on self-delivering RNAi technology.”
About ScarringWith cosmetic surgical procedures becoming increasingly more common to improve appearance, or to correct skin imperfections as a result of trauma or disease, scarring has become a much more significant side effect of such interventions. RXI-109 has been shown in cell culture and animal models to suppress or silence the over-expression of CTGF, a growth factor that is essential in the wound healing cascade, and which is also the cause of excessive scarring when it continues to exert its effect on a healing wound for too long. About RXi Pharmaceuticals RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, next-generation RNAi platform. Therapeutics that use RNA interference, or “RNAi,” have great promise because of their ability to “silence,” or down-regulate, the expression of a specific gene that may be overexpressed in a disease condition. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, RXi’s first RNAi product candidate, RXI-109, is now entering into a new phase of its development, in which clinical studies in humans will evaluate if the promising results that have been obtained in cell culture and animal studies will prove to be relevant in humans.
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