MARLBOROUGH, Mass.,
Sept. 6, 2017 /PRNewswire/
-- 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.
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"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.
About Samcyprone™
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.
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