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
tmcgrillen@rxipharma.com
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SOURCE RXi Pharmaceuticals Corporation