RXi Pharmaceuticals Announces the Initiation of a Phase 2 Trial in Dermatology with Samcyprone for Cutaneous Warts

Dec 21, 2015, 07:02 ET from RXi Pharmaceuticals Corporation

MARLBOROUGH, Mass., Dec. 21, 2015 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company focused on discovering and developing innovative therapies primarily in the areas of dermatology and ophthalmology today announced the initiation of a Phase 2 clinical trial in dermatology.  The clinical study RXI-SCP-1502 will evaluate the safety and clinical activity of Samcyprone™ on the clearance of cutaneous warts.

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"We are very pleased to be advancing our proprietary topical formulation of DPCP, Samcyprone™, into a Phase 2 clinical trial," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals.  He further added, "The Company continues to deliver the building blocks to increase shareholder value as promised.  We look forward to providing clinical data from all of our ongoing clinical trials over the course of 2016."    

RXI-SCP-1502 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 on one preselected wart lesion. Once the sensitization response is confirmed, subjects will 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, 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 major role in controlling HPV infections. Therefore, treatment techniques such as immunotherapy have been used to activate the immunologic response to HPV.

The Company finalized an exclusive global license to Samcyprone™ from Hapten Pharmaceuticals, LLC in February of this year. In a small proof of concept trial in cutaneous warts carried out previously by Hapten Pharmaceuticals, Samcyprone™ was considered safe and had a statistically significant beneficial effect as a wart treatment compared to placebo.

About Samcyprone™

As a proprietary topical formulation of diphenylcyclopropenone (DPCP), Samcyprone™ is an immunomodulator that 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 play a key role in cell-mediated immunity. 

DPCP has been used for several decades by physicians and is supported in recent 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 biotechnology company focused on discovering and developing innovative therapeutics primarily in the areas of dermatology and ophthalmology that address high-unmet medical needs.  Building on the pioneering work of RXi's Scientific Advisory Board Chairman and Nobel Laureate Dr. Craig Mello, 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 scar formation. 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 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.  

Forward-Looking Statements

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.

Contact  RXi Pharmaceuticals Corporation Tamara McGrillen 508-929-3646 tmcgrillen@rxipharma.com 

SOURCE RXi Pharmaceuticals Corporation



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