MARLBOROUGH, Mass.,
Oct. 15, 2015 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company
that owns a broad intellectual property portfolio including a
unique self-delivering RNAi platform, today announced that
results from a blinded panel and an Investigator review show that
incision sites treated with RXI-109 after scar revision surgery
achieved better scores as compared to control incision sites in the
same subjects, three months post scar revision surgery.
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"The use of RXI-109 after scar revision surgery has a visible,
beneficial effect on suppression of hypertrophic scarring as
compared with untreated control scars, at three months following
surgery," said Dr. Joseph P.
Hunstad, FACS, Founder of The Hunstad Kortesis Center for
Cosmetic Plastic Surgery and MedSpa, one of the Principal
Investigators in this RXI-109 study.
In the first two arms of this ongoing Phase 2a study, subjects
were given six intradermal injections of RXI-109, either at 5 mg/cm
or 10 mg/cm, beginning two weeks after scar revision surgery, with
the last of the six doses administered three months post revision
surgery. Subjects had one portion of the revised scar treated with
RXI-109, whereas another part of the scar was revised but left
untreated. This 3-month analysis included 16 subjects of which 15
were evaluable and 1 was lost to follow-up. Of those 15 subjects,
eight were treated with 5 mg/cm of RXI-109 and seven were treated
with 10 mg/cm of RXI-109. All subjects were assessed using
four different evaluation methods:
- POSAS (Physician and Observer Scar Assessment Scale): A
compiled score based on investigator assessments of factors
contributing to scar quality. These scores are provided by the
investigators for both the treated and the untreated portion of the
scar of their individual subjects in person;
- VAS (Visual Analogue Scale): A score based on a 10 point scale
ranging from "1" (fine line scar) to "10" (worst scar possible)
provided by the investigators for their individual subjects;
- A blinded assessment of photographs of the revision sites for
15 subjects by Investigators in which the clinicians were asked to
indicate for Scars A and B as to which is 'better' or 'not
different';
- A separate assessment of photographs of the revision sites for
15 subjects by a blinded panel, separate from the Investigators, in
which the panel members were asked to indicate for Scars A and B as
to which is 'better' or 'not different' .
Overall, the RXI-109 treated revision sites were scored
statistically significantly better than the untreated revision
sites in all four evaluations. Both dose levels of RXI-109
were equally well tolerated with occasional transient redness and
itching occurring in both dose levels. Moreover, the higher
dose of 10 mg/cm did not appear to add clinical benefit over the 5
mg/cm dose, leading to the conclusion that the next cohorts in this
ongoing RXI-109-1402 study will be treated with the 5 mg/cm dose.
These subsequent cohorts will include evaluation of additional
treatments through six months to further define the optimum
treatment regimen.
"We are very pleased with the outcome of the 3-month evaluation
of our ongoing Phase 2a study with RXI-109 for the treatment of
hypertrophic scars following scar revision surgery," said Dr.
Geert Cauwenbergh, President and CEO
of RXi Pharmaceuticals. He added, "Not only do these four different
evaluation methods confirm the same positive conclusion, the
results also bring us another step closer to identifying the final
treatment schedule for RXI-109 in the management of surgical
incision sites in subjects prone to hypertrophic scarring. Our
continued clinical development will now focus on identifying the
optimum treatment length using the 5 mg/cm dose".
Dr. Cauwenbergh will present data from the Company's dermal
clinical program with RXI-109 today at 4:30
p.m. EDT at the Dawson James Securities Stock Growth
Conference. The presentation will be webcast and available on
the "Investors" section of the Company's website,
www.rxipharma.com.
About Dr. Joseph
Hunstad
Dr. Hunstad is one of the Principal Investigators for the
Company's dermatology clinical program with RXI-109. His site has
treated a large number of the subjects in the Company's clinical
trials with RXI-109 to date. He received his Doctor of
Medicine degree from the College of Human Medicine at Michigan State University and completed a General
Surgery residency at Butterworth Hospital in Grand Rapids. He completed his Plastic Surgery
residency at the Grand Rapids Area Medical Education Center, where
he later served as Plastic Surgery Chief Resident for a year. He
completed a Fellowship in Reconstructive Microsurgery at the MECOM
Microsurgical Institute in Houston
and is licensed to practice in North
Carolina, Michigan, and
Texas. Dr. Hunstad has been named
one of the Best Plastic Surgeons in America by Castle Connolly,
among numerous other awards and distinctions.
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 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.
Building on the pioneering work of RXi's Scientific Advisory
Board Chairman and Nobel Laureate Dr. Craig
Mello, 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 and a
Phase 1/2 trial is planned to initiate this year in ophthalmology.
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
tmcgrillen@rxipharma.com
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SOURCE RXi Pharmaceuticals Corporation