(+) RXi Pharmaceuticals receives FDA clearance to begin clinical trial with RXI-109 (RXi Pharma) - May 31, 2012 - RXi Pharmaceuticals announced that it has received clearance for its IND from the US FDA to initiate clinical trials with RXI-109; 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
Anticipated P1 trial • IND approval • Fibrosis
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May 31, 2012
RXi Pharmaceuticals Receives FDA Clearance to Begin Clinical Trial with RXI-109
First study to evaluate tolerance and potential surrogate parameters for scar reduction
WORCESTER, Mass.–(BUSINESS WIRE) - 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.”
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