MARLBOROUGH, Mass.,
Nov. 5, 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 1/2 clinical trial in
ophthalmology. The clinical study RXI-109-1501 will evaluate
the safety and clinical activity of RXI-109 to prevent the
progression of retinal scarring, a harmful component of numerous
retinal diseases.
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"We are very pleased to have initiated our first clinical trial
in the area of ophthalmology. Currently, there is no
effective way to prevent the formation or progression of retinal
scars that may occur as a consequence of several devastating ocular
diseases. In advanced neovascular or 'wet' age-related
macular degeneration, our first area of study, retinal scarring can
result in continued vision loss," said Dr. Pamela Pavco, Chief Development Officer of RXi
Pharmaceuticals. She further added, "RXI-109 has the potential to
fill this unmet medical need by reducing this continuing damage to
the retina and, in doing so, helping to preserve vision in these
individuals for a longer period of time."
RXI-109-1501 is a multi-center, multi-dose, dose escalation
trial conducted in subjects with advanced neovascular or 'wet'
age-related macular degeneration (AMD). In this Phase 1/2 trial,
each subject will receive a total of four doses of RXI-109 at one
month intervals. RXI-109 will be administered by intravitreal
injection in one eye only. The dosing period (3 months) will
be followed by a four month observation period. The safety
and tolerability of RXI-109, as well as the potential for clinical
activity, will be evaluated over the course of the study using
numerous assessments to monitor ocular health and visual
acuity. Several dose levels will be evaluated in a small
number of subjects in this first trial in order to establish safety
information and to help determine the dosing regimen for continued
study.
RXI-109 is a self-delivering RNAi (sd-rxRNA®)
compound developed to target connective tissue growth factor
(CTGF), a key regulator of scar formation in the skin and known to
be involved in retinal scarring as well. Wet AMD is currently
treated with anti-VEGF therapies to block vascular endothelial
growth factor (VEGF) from causing blood vessel leakiness and the
consequential damage to the retina. However, as the disease
progresses, many advanced patients also experience retinal scarring
which leads to further vision loss. Our ultimate goal is to reduce
the scarring that is secondary to advanced wet AMD and in doing so,
preserve vision for a longer period time.
Currently, there are no approved therapeutics in the U.S. for
the treatment and prevention of subretinal fibrosis. Such a therapy
could benefit patients with the advanced wet AMD as well as those
with other ocular indications with a scarring component such as
proliferative vitreoretinopathy (PVR) and proliferative diabetic
retinopathy (PDR).
About RXI-109: Novel Self-delivering RNAi
(sd-rxRNA®) Compound with Built-In Drug-Like
Properties
Building on the pioneering work of RXi's Scientific Advisory
Board Chairman and Nobel Laureate Dr. Craig
Mello, scientists at RXi developed novel sd-rxRNA compounds
where drug-like properties are built into the RNAi compound itself.
sd-rxRNA compounds are novel RNAi compounds with enhanced
properties for therapeutic use including: efficient
spontaneous cellular uptake, stability in vivo, reduced
potential for immune stimulation, and potent, long-lasting
intracellular activity. All cell types tested (primary,
neuronal and non-adherent) internalize sd-rxRNA compounds uniformly
and efficiently, resulting in potent and long lasting
silencing. Efficient cellular uptake is observed both in
vitro and in vivo, including tissues like skin, retina,
lung, spinal cord and liver.
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.
In addition to the Phase 1/2 trial in ophthalmology described
here, RXI-109 is also currently being evaluated in Phase 2a
clinical trials in dermatology. Approximately 100 subjects
have been treated with RXI-109 by intradermal injection in all
trials to date. Multiple intradermal injections were well tolerated
at all dose levels. RXI-109 was shown to cause a
dose-dependent silencing of CTGF messenger RNA and protein levels
in the treated areas of the skin compared to placebo and
preliminary results from Phase 2a studies indicate a clinical
effect on scar appearance.
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 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