MARLBOROUGH, Mass.,
Aug. 31, 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 that the 30-day review period
following the filing of the Company's Investigational New Drug
(IND) for ocular indications with the U.S. Food and Drug
Administration (FDA) has passed and the IND is now active.
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As outlined in the Company's Second Quarter Earnings Call on
August 12, 2015, preparations are
ongoing for the initiation of a Phase 1/2 trial in Ophthalmology to
evaluate the safety and clinical activity of RXI-109 to prevent the
progression of the scarring component of retinal diseases. The
process to obtain approval from the Investigational Review Board
(IRB) is underway. If the current plan is acceptable to the IRB, a
multi-dose, dose-escalating trial will initiate early in the fourth
quarter of this year.
This Phase 1/2 study will be the Company's first clinical trial
with RXI-109 in Ophthalmology. RXI-109-1501 will focus on patients
with advanced age-related macular degeneration or advanced wet AMD.
RXI-109 is a self-delivering RNAi (sd-rxRNA®) compound developed to
target connective tissue growth factor (CTGF), a key regulator in
scar formation. The goal is to block the formation of
sub-retinal scarring that is secondary to the neovascular disease
of wet AMD in order to preserve vision for a longer period of time.
"As mentioned during our earnings call a few weeks ago, we are
pleased to be moving forward one of our seven key initiatives for
shareholder value creation," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals. He
further added, "Progressing the clinical program for RXI-109 in
ophthalmology is a major step in our approach to demonstrate the
value of our self-delivering RNAi technology to alleviate diseases
in patients who today have little hope for improvements in their
advanced disease states. Overall, we are pleased to be advancing
RXI-109 for both Dermatology and Ophthalmology, and look forward to
initiating additional targeted programs using our self-delivering
RNAi platform in these two therapeutic areas."
Currently, there are three ongoing Phase 2a trials evaluating
the effect of RXI-109 on scar formation in the skin after surgical
revision of hypertrophic scars or keloids. Approximately 100
subjects have been treated with RXI-109 by intradermal injection in
all trials to date. RXI-109 has proven to be safe and well
tolerated in that target population. The Company expects to
provide further updates on its Dermatology and Ophthalmology
clinical programs in the coming months.
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. 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 scarring. It also
includes an immunomodulator, Samcyprone™, a proprietary topical
formulation of diphenylcyclopropenone (DPCP), for the treatment of
such disorders as alopecia areata, warts, non-malignant skin tumors
and cutaneous metastases of melanoma.
RXi's novel, self-delivering RNAi (sd‑rxRNA®) compounds are
designed for therapeutic use and have drug-like properties, such as
high potency, target specificity, serum stability, reduced immune
response activation, and efficient cellular uptake. sd-rxRNAs have
been shown, in vitro and in vivo, to
achieve efficient spontaneous cellular uptake and potent,
long-lasting intracellular activity.
RXI-109, an sd-rxRNA compound, is the Company's first clinical
development candidate. RXI-109 silences Connective Tissue Growth
Factor (CTGF), which plays a key role in tissue regeneration and
repair and is initially being developed to reduce or inhibit scar
formation in the skin and in the eye. RXI-109 is currently
being evaluated in Phase 2a clinical trials in dermatology. The
Company's sd-rxRNA technology platform is broadly protected by
multiple issued patents and numerous patent applications.
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
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SOURCE RXi Pharmaceuticals Corporation