MARLBOROUGH, Mass., March 23, 2015 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering and developing innovative therapies addressing high-unmet medical needs primarily in the area of dermatology and ophthalmology, today announced at the annual meeting of the American Academy of Dermatology in San Francisco, several significant advancements within its dermatological programs.
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Today, Dr. Lyn Libertine, Vice President Medical Affairs and Safety Assessment of RXi Pharmaceuticals will present two poster presentations that will provide an overview of the Company's first clinical compound, RXI-109, a self-delivering RNAi (sd‑rxRNA®) compound currently being evaluated in Phase 2a clinical trials. The first presentation, "RXI‑109 Treatment to Reduce the Formation of Keloids Following Keloidectomy," will be held today from 12:10 to 12:15 p.m. PDT. Keloids are a type of abnormal scar that can result from skin trauma where collagen is continuously 'layed' down during the proliferation phase of the wound healing process and that grows beyond the boundaries of the original wound. For keloids, versus normal scars, the proliferation phase can continue for well over one year.
Enrollment has completed and data collection and analysis are ongoing for study RXI-109-1401 in which the clinical effect of RXI-109 treatment is being evaluated for its ability to reduce recurrence of keloids following keloidectomy. The Company held a meeting with an expert panel comprised of clinical advisors, practicing dermatologists and plastic surgeons, including investigators participating in this study. This panel conducted a review of preliminary data from this study where treatment with RXI‑109 was limited to only four weekly injections over a 1-month period. The panel members looked at blinded pictures of the first seven subjects for the first few months after treatment and more often identified the placebo-treated site as showing faster recurrence of the keloid. No major side effects or safety concerns have been reported. Based on these preliminary clinical observations, a reduced recurrence of keloids treated with RXI-109 as compared to placebo, this Clinical Advisory Panel provided a unanimous recommendation to the Company to lengthen the treatment regimen and to increase the number of doses with RXI-109 to reflect the chronic and aggressive nature of the formation process of a keloid. The Company will move forward with those recommendations and initiate an additional keloid trial in the near future.
Dr. Libertine's second poster presentation, "Update on Phase 2 Clinical Trial Results of RXI‑109 Treatment to Reduce the Formation of Hypertrophic Dermal Scars", will be held today from 12:20 to 12:25 p.m. PDT. Hypertrophic scars are abnormal scars that are raised above the normal skin surface and can be reddened or darker than the existing skin tone. These scars result in part from an increased level of collagen and are less 'elastic' than the surrounding skin. Studies RXI-109-1301 and RXI-109-1402 are investigating the clinical effect of RXI-109 in reducing the recurrence of hypertrophic scar formation following surgical scar excision. The Company has learned from RXI-109-1301 that initiating treatment with RXI-109 two weeks post scar revision surgery is beneficial versus initiating treatment immediately. The Company has also shown, in study 1301, that when treatment with RXI-109 was initiated 2-weeks post scar revision surgery, blinded evaluators were able to identify accurately the RXI-109 treated site at the 1-month and 3-month follow-up more frequently than when treatment was initiated immediately post scar revision surgery. With the observations from study 1301, the Company's third Phase 2a clinical trial, RXI-109-1402, was designed with an optimized dosing regimen. Enrollment has completed in study 1301 and subjects will continue to be monitored. Subjects in Study 1402 have entered on a rolling basis and enrollment is more than 50% complete.
Dr. Libertine's poster presentations will be at the 73rd Annual Meeting of the American Academy of Dermatology. This meeting features world-renowned leaders presenting the latest research in the diagnosis and medical, surgical and cosmetic treatment of skin, hair and nail conditions and will be held at The Moscone Center in San Francisco, CA. Both presentations will be at the Center E‑Poster Presentation, Center 3, in the Wound Healing and Ulcers section. The posters will be available on the Company's website at www.rxipharma.com approximately one hour after the presentation.
Dr. William Levis, Lifetime Professor of Dermatology at Rockefeller University and co-developer of Samcyprone™, presented a poster on Sunday, March 22, 2015 at the American Academy of Dermatology, "Diphencyprone for the Treatment of Dermatological Disorders with an Immunological Component". Samcyprone™ is a proprietary topical immunomodulating formulation containing the active agent diphencyprone (DPCP). RXi Pharmaceuticals recently closed an exclusive global license to Samcyprone™ in February 2015. The Company is currently evaluating next steps for Samcyprone™ and expects to initiate a second Phase 2a clinical trial for the treatment of warts by the end of 2015. Dr. Levis' presentation and additional information on Samcyprone™ may be found on the Company's website, www.rxipharma.com.
The Company also announced today that it has entered into a collaboration with Dr. James Krueger of The Rockefeller University for the study of the effects of Samcyprone™ on the changes in gene expression profiles influenced by diphencyprone in patients with cutaneous metastases of solid tumors treated with our product. In addition to being of high clinical relevance to patients who suffer from these metastases, this collaborative effort may lead to the identification of proteins that could be good targets for novel potent and selective RNAi compounds based on our sd-rxRNA® delivery platform. James G. Krueger M.D. Ph.D. is the D. Martin Carter Professor in Clinical Investigation and he serves as the Director of the Milstein Medical Research Program, which conducts new clinical studies of the pathogenesis of melanoma and other pigmentory diseases at The Rockefeller University Hospital in New York, NY. (http://www.rockefeller.edu/research/faculty/labheads/JamesKrueger/)
The Company has also entered into a collaboration with Dr. Maria Hordinsky of the University of Minnesota and the National Alopecia Areata Foundation (NAAF) for the study of Samcyprone™ in the treatment of alopecia areata, with the aim to optimize the treatment regimen of diphencyprone is this dermatological disorder, and to better understand the mechanism of action of the drug in this disease. This collaboration could lead to novel targets for development of potent RNAi compounds against this disease based on our sd-rxRNA® platform. Maria K. Hordinsky, M.D. is Professor and Chair of the Department of Dermatology at the University of Minnesota, Twin Cities campus. Dr. Hordinsky is the current president of the Association of Professors of Dermatology, Chair of the Clinical Research Advisory Council of the National Alopecia Areata Foundation and is Secretary/Treasurer of the North American Hair Research Society. (http://www.dermatology.umn.edu/meet-our-faculty/maria-hordinsky/index.htm)
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics addressing high-unmet medical needs, primarily in the area of dermatology and ophthalmology. 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 retinal scarring. It also includes an immunomodulator, Samcyprone™, a proprietary gel formulation of diphenylcyclopropenone (DPCP), for the treatment of such disorders as alopecia areata, warts, and cutaneous metastases of melanoma.
RXi's robust pipeline, coupled with an extensive patent portfolio, provides for product and business development opportunities across a broad spectrum. 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about future expectations and planned and future development of our product candidates, technologies and partnerships. 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.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com
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