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
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SOURCE RXi Pharmaceuticals Corporation