RXi Pharmaceuticals Receives Orphan Drug Designation for Samcyprone™ from the U.S. FDA for the Treatment of Malignant Melanoma Stage IIb to IV
MARLBOROUGH, Mass., April 17, 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 that address high-unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation of its second clinical candidate, Samcyprone™, for the treatment of Malignant Melanoma Stage IIb to IV. A number of patients with Stage IIb to IV malignant melanoma develop cutaneous metastases. Samcyprone™ is being developed for treatment of these metastases.
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Samcyprone is a topical formulation of Diphenylcylcopropenone (DPCP) in clinical development for the treatment of warts, alopecia areata and cutaneous metastases of melanoma. The mechanism of action for treatment cutaneous metastases of melanoma involves elicitation of an immune response in the skin that subsequently causes destruction of the cutaneous tumor.
Melanomas, cancers that arise from melanocytes, are the most aggressive form of skin cancer. Once melanoma has spread beyond the localized area of the primary lesion, the survival rate decreases and melanoma becomes increasingly more difficult to treat successfully. Management of metastatic melanoma, including cutaneous metastases, is challenging and represents an area of great unmet need.
"This is an important step for patients suffering from this devastating disease," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "This orphan designation underscores the value of expanding our clinical pipeline through the acquisition of Samcyprone. It provides the Company with access to cost-saving benefits and incentives to aid in the development of this drug, and establishes a link to one of our other preclinical research programs with our sd-rxRNA platform focused on tyrosinase, a key enzyme in the synthesis of melanin."
About Orphan Drug Designation
Orphan drug status is granted for novel drugs or biologics to treat rare medical diseases or conditions that affect less than 200,000 people in the United States. The designation qualifies the sponsor for numerous incentives including seven years of market exclusivity after the drug's approval, tax credits for clinical research costs and application fee reductions.
About Samcyprone™
Samcyprone™ is a proprietary topical formulation of diphenylcyclopropenone (DPCP). Samcyprone™ is being evaluated for the treatment of warts, alopecia areata and cutaneous metastases of malignant melanoma. DPCP is an immunomodulating agent that works by eliciting a T-cell response. While the drug DPCP has been used for decades, it is expected that Samcyprone™ will result in a better safety profile, a more consistent drug product and equivalent efficacy at lower doses. It is also expected to achieve market exclusivity post approval. Currently, an investigator sponsored clinical trial in cutaneous metastases of melanoma, as well as a new investigator sponsored clinical trial in alopecia areata are ongoing. In addition, RXi plans to initiate a Phase 2a clinical trial in warts for Samcyprone by the end of this year.
The mechanism of action of Samcyprone™ is linked to DPCP's ability to alter the expression of multiple genes and miRNAs involved in the immune response. RXi's unique sd-rxRNA® platform allows for the rapid identification of lead compounds for multiple targets in different therapeutic areas. Our work with Samcyprone™ may also allow us to discover specific targets and develop new sd-rxRNAs for the potential treatment of immunological disorders that are relevant to the skin as well as various systemic diseases.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering and developing innovative therapeutics primarily in the area 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 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. 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. 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
[email protected]
SOURCE RXi Pharmaceuticals Corporation
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