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News Release - September 6, 2017
RXi Pharmaceuticals Announces Completion of Enrollment of Phase 2 Clinical Trial with Samcyprone for Cutaneous WartsMARLBOROUGH, Mass., Sept. 6, 2017 -- (Healthcare Sales & Marketing Network) -- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, today announced the completion of enrollment in its Phase 2 clinical trial, RXI-SCP-1502, with Samcyprone™. This study is evaluating the safety and clinical activity of Samcyprone™ for the clearance of cutaneous warts.
"The enrollment of the second cohort in this study was completed in a very short amount of time," said Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals. He added that, "I would like to thank the investigators and the entire study team for their efforts. This milestone will allow us to share study data read-outs before the end of the year. The second cohort uses a more subject-friendly protocol, namely a lower sensitization dose. Based on preliminary data of the second cohort, a high rate of skin sensitization is achieved - similar to the rate seen in the first cohort. This is exciting since such a skin sensitization is a prerequisite for a therapeutic response."
Expanding its dermatology franchise in 2015, the Company completed an exclusive global license to Samcyprone™ from Hapten Pharmaceuticals, LLC. After the transfer of the IND to RXi, the Company completed a process to optimize the topical formulation followed by the initiation of its Phase 2 study, RXI-SCP-1502. This study is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart present for at least four weeks. In this Phase 2 trial, subjects are first treated with a sensitization dose on the inner arm and one or more preselected wart lesion(s). Once the sensitization response is confirmed, subjects continue with weekly treatments for 10 weeks. Wart clearance will be evaluated based on Investigator's Global Assessment Score (IGAS) and wart measurements over time during the treatment period.
Samcyprone™ is being studied for the treatment of cutaneous warts, which are benign epidermal tumors caused by human papillomaviruses (HPVs). They are extremely common, being experienced by most people at some time during their lives. There are many different treatment modalities for warts including physical or chemical destruction and immunomodulation. However, treatment of warts is complicated by low success rates, prolonged duration of therapy, and the potential for recurrence. It is well established that cell-mediated immune response plays a significant role in controlling HPV infections. Therefore, treatment techniques such as immunotherapy have been used to activate the immunologic response to HPV.
Samcyprone™ is a proprietary topical formulation of the small molecule diphenylcyclopropenone (DPCP). This topical immunomodulator works by initiating a T-cell response. Immunomodulators are the active agents in immunotherapy treatments for diseases that induce, enhance or suppress an immune response. They are a diverse array of recombinant, synthetic and natural preparations that help to regulate or normalize the immune system. T-cells or T lymphocytes are a type of white blood cell that plays a key role in cell-mediated immunity.
DPCP has been used for several decades by physicians and is supported in publications for its use as an immunomodulator for the treatment of warts, alopecia areata and cutaneous metastases of malignant melanoma. It has never been reviewed or approved by a regulatory authority as a drug; however, DPCP is a new chemical entity under a U.S. IND. The Company's proprietary topical formulation of DPCP, Samcyprone™, is expected to achieve market exclusivity post approval. In March 2015, the Company was granted Orphan Drug Designation for Samcyprone™ by the U.S. Food and Drug Administration for the treatment of malignant melanoma stage IIb to IV.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a clinical-stage company developing innovative therapeutics that address significant unmet medical needs. Building on the pioneering discovery of RNAi, scientists at RXi have harnessed the naturally occurring RNAi process which can be used to "silence" or down-regulate the expression of a specific gene that may be overexpressed in a disease condition. RXi developed a robust RNAi therapeutic platform including self-delivering RNA (sd-rxRNA®) compounds, that have the ability to selectively block the expression of any target in the genome, thus providing applicability to many therapeutic areas. Our current programs include dermatology, ophthalmology, and cell-based cancer immunotherapy. RXi's extensive patent portfolio provides for multiple product and business development opportunities across a broad spectrum of therapeutic areas, and we actively pursue research collaborations, partnering and out-licensing opportunities with academia and pharmaceutical companies. For additional information, visit 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.
Source: RXi Pharmaceuticals
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