RXi Pharmaceuticals Announces Positive Results from Phase 2 Trial with RXI-109 for Dermal Scarring
RXi's Chief Development Officer,
Overall Efficacy Results
- Using the Investigator Scar Assessment Scale, which enables a structured clinical evaluation of scar quality, the difference between RXI-109 treated scars and untreated (control) scars, was statistically significant at all follow-up time points, for one of the treatment arms. The improvement over untreated scars was a mean 6.88 point change at 3 months (p=0.028), a mean 8.00 point change (p=0.013) at 6 months and a mean 7.53 point change (p=0.013) at 9 months post revision surgery. The Investigator Scar Assessment Scale is a validated scoring tool which accounts for several parameters including surface area, pliability, relief, thickness, pigmentation and vascularity.
- Using a qualitative measure of overall scar appearance (visual-analog-scale), the difference noted by the Investigator was also statistically significant for all follow-up time points, for the same treatment arm. The improvement over untreated scars was a mean 1.58 point change at 3 months (p=0.012), a mean 1.89 point change (p=0.004) at 6 months and a mean 1.55 point change (p=0.017) at 9 months post revision surgery.
- As an exploratory endpoint, patient reported outcome for scar ranking was evaluated. Patients were asked to answer which scar segment (A or B) looks 'better' or if they thought they were 'not different'. For the treatment arm mentioned above, 88% of the patients and 86% of the investigators preferred the RXI-109 treated scar.
Safety and tolerability
- Treatment with RXI-109 was well tolerated in treatment arms. There were no drug-related serious adverse events (SAEs) and most other treatment emergent adverse events (AEs) were those commonly found with intradermal injections, such as injection site pain (17.4%), and injection site erythema (11.8%).
Additional details from the Phase 2 study will be submitted for presentation at a future scientific conference.
Approximately 42 million surgeries occur in
RXI-109 and RXi's sd-rxRNA technology platform are broadly protected in
Dr. Hunstad is one of the Principal Investigators for the Company's dermatology clinical program with RXI-109. His site has treated a large number of the subjects in the Company's clinical trials with RXI-109 to date. He received his Doctor of Medicine degree from the
About RXi's self-delivering RNAi (sd-rxRNA) technology platform
sd-rxRNA, RXi's proprietary self-delivering RNAi platform, is a single chemically modified compound with delivery and therapeutic properties built directly into the compound itself. The compound is asymmetrical with a phosphorothioate backbone and contains chemical modifications that provide for efficient cellular uptake and gene silencing. These compounds are potent, stable and specific, and demonstrated to be safe and active in a clinical setting.
RXi's novel sd-rxRNA technology differs from natural and most synthetic RNA interference (RNAi) molecules in that they are chemically modified to allow for efficient internalization of the compounds by cells and silencing of the targeted genes. Importantly, unlike other naked siRNA compounds, delivery of sd-rxRNAs are not limited to a specific cell type. For local delivery and ex vivo cell-based therapeutic applications, our compounds do not require delivery vehicles. This is a major advantage, since delivery vehicles can have related toxicity that affects cell viability. sd-rxRNA has demonstrated nearly 100 percent transfection efficiency with high cell viability in numerous cell types.
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: our ability to successfully develop RXI-109, Samcyprone™ and our other product candidates (collectively "our product candidates"); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; our ability to enter into strategic partnerships and the future success of these strategic partnerships; and our ability to deploy our sd-rxRNA® technology through partnerships, as well as the prospects of these partnerships to provide positive returns. Forward-looking statements about expectations and development plans of RXi's product candidates and partnerships involve significant risks and uncertainties, including the following: risks that we may not be able to successfully develop and commercialize our product candidates; risks that product development and clinical studies may be delayed, not proceed as planned and/or be subject to significant cost over-runs; risks related to the development and commercialization of products by competitors; risks related to our ability to control the timing and terms of collaborations with third parties; and risks that other companies or organizations may assert patent rights preventing us from developing or commercializing our product candidates. Additional risks are detailed in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors." Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our 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.
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RXi Pharmaceuticals Corporation, Tamara McGrillen, 508-929-3646