MARLBOROUGH, Mass., Oct. 15, 2015 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company that owns a broad intellectual property portfolio including a unique self-delivering RNAi platform, today announced that results from a blinded panel and an Investigator review show that incision sites treated with RXI-109 after scar revision surgery achieved better scores as compared to control incision sites in the same subjects, three months post scar revision surgery.
"The use of RXI-109 after scar revision surgery has a visible, beneficial effect on suppression of hypertrophic scarring as compared with untreated control scars, at three months following surgery," said Dr. Joseph P. Hunstad, FACS, Founder of The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa, one of the Principal Investigators in this RXI-109 study.
In the first two arms of this ongoing Phase 2a study, subjects were given six intradermal injections of RXI-109, either at 5 mg/cm or 10 mg/cm, beginning two weeks after scar revision surgery, with the last of the six doses administered three months post revision surgery. Subjects had one portion of the revised scar treated with RXI-109, whereas another part of the scar was revised but left untreated. This 3-month analysis included 16 subjects of which 15 were evaluable and 1 was lost to follow-up. Of those 15 subjects, eight were treated with 5 mg/cm of RXI-109 and seven were treated with 10 mg/cm of RXI-109. All subjects were assessed using four different evaluation methods:
- POSAS (Physician and Observer Scar Assessment Scale): A compiled score based on investigator assessments of factors contributing to scar quality. These scores are provided by the investigators for both the treated and the untreated portion of the scar of their individual subjects in person;
- VAS (Visual Analogue Scale): A score based on a 10 point scale ranging from "1" (fine line scar) to "10" (worst scar possible) provided by the investigators for their individual subjects;
- A blinded assessment of photographs of the revision sites for 15 subjects by Investigators in which the clinicians were asked to indicate for Scars A and B as to which is 'better' or 'not different';
- A separate assessment of photographs of the revision sites for 15 subjects by a blinded panel, separate from the Investigators, in which the panel members were asked to indicate for Scars A and B as to which is 'better' or 'not different' .
Overall, the RXI-109 treated revision sites were scored statistically significantly better than the untreated revision sites in all four evaluations. Both dose levels of RXI-109 were equally well tolerated with occasional transient redness and itching occurring in both dose levels. Moreover, the higher dose of 10 mg/cm did not appear to add clinical benefit over the 5 mg/cm dose, leading to the conclusion that the next cohorts in this ongoing RXI-109-1402 study will be treated with the 5 mg/cm dose. These subsequent cohorts will include evaluation of additional treatments through six months to further define the optimum treatment regimen.
"We are very pleased with the outcome of the 3-month evaluation of our ongoing Phase 2a study with RXI-109 for the treatment of hypertrophic scars following scar revision surgery," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added, "Not only do these four different evaluation methods confirm the same positive conclusion, the results also bring us another step closer to identifying the final treatment schedule for RXI-109 in the management of surgical incision sites in subjects prone to hypertrophic scarring. Our continued clinical development will now focus on identifying the optimum treatment length using the 5 mg/cm dose".
Dr. Cauwenbergh will present data from the Company's dermal clinical program with RXI-109 today at 4:30 p.m. EDT at the Dawson James Securities Stock Growth Conference. The presentation will be webcast and available on the "Investors" section of the Company's website, www.rxipharma.com.
About Dr. Joseph Hunstad
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 College of Human Medicine at Michigan State University and completed a General Surgery residency at Butterworth Hospital in Grand Rapids. He completed his Plastic Surgery residency at the Grand Rapids Area Medical Education Center, where he later served as Plastic Surgery Chief Resident for a year. He completed a Fellowship in Reconstructive Microsurgery at the MECOM Microsurgical Institute in Houston and is licensed to practice in North Carolina, Michigan, and Texas. Dr. Hunstad has been named one of the Best Plastic Surgeons in America by Castle Connolly, among numerous other awards and distinctions.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics primarily in the areas of dermatology and ophthalmology that address high-unmet medical needs. Our discovery and clinical development programs are based on siRNA technology as well as immunotherapy agents. These compounds include, but are not limited to, our proprietary, self-delivering RNAi (sd-rxRNA®) compounds for the treatment of dermal and ocular scarring. It also includes an immunomodulator, Samcyprone™, a proprietary topical formulation of diphenylcyclopropenone (DPCP), for the treatment of disorders such as warts, alopecia areata, non-malignant skin tumors and cutaneous metastases of melanoma.
RXi's novel, self-delivering RNAi (sd-rxRNA®) compounds 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. sd-rxRNAs have been shown, in vitro and in vivo, to achieve efficient spontaneous cellular uptake and potent, long-lasting intracellular activity.
Building on the pioneering work of RXi's Scientific Advisory Board Chairman and Nobel Laureate Dr. Craig Mello, RXI-109, an sd-rxRNA compound, is the Company's first clinical development candidate. RXI-109 silences Connective Tissue Growth Factor (CTGF), which plays a key role in tissue regeneration and repair and is initially being developed to reduce or inhibit scar formation in the skin and in the eye. RXI-109 is currently being evaluated in Phase 2a clinical trials in dermatology and a Phase 1/2 trial is planned to initiate this year in ophthalmology. The Company's sd-rxRNA technology platform is broadly protected by multiple issued patents and numerous patent applications.
RXi's robust pipeline, coupled with an extensive patent portfolio, provides for product and business development opportunities across a broad spectrum of therapeutic areas. We are committed to being a partner of choice for academia, small companies, and large multinationals. We welcome ideas and proposals for strategic alliances, including in- and out-licensing opportunities, to advance and further develop strategic areas of interest. Additional information may be found on the Company's website, 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: 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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