MARLBOROUGH, Mass.,
Dec. 17, 2014 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
biotechnology company focused on discovering, developing and
commercializing innovative therapies addressing major unmet medical
needs using RNA-targeted technologies, today announced
completion of enrollment in its first Phase 2a study,
RXI-109-1301. The preliminary results from the 3-month
observations confirmed the 1-month findings that were reported in
September of this year:
Logo -
http://photos.prnewswire.com/prnh/20130917/NE80755LOGO
1.
|
When treatment with
RXI-109 was initiated 2-weeks post scar revision surgery, blinded
evaluators were able to identify accurately the RXI-109 treated
site at the 3-month follow-up more frequently (54%) than when
treatment was initiated immediately post scar revision surgery
(24%) (p< 0.0001 Fisher exact 2-tailed).
|
2.
|
These data provide
guidance that dosing with RXI-109 during the proliferation phase
provides a better outcome than dosing during the acute inflammatory
phase of the wound healing process.
|
3.
|
The results support
the Company's decision, for the ongoing Phase 2a studies, to start
treatment 2-weeks post scar revision surgery (at the end of the
acute inflammation phase), and explore extension of the treatment
during the weeks of the proliferation phase (the period in the
wound healing process during which hypertrophic scars can
develop).
|
Based on these observations, the treatment regimens for the
ongoing studies for revised keloids and scars, RXI-109-1401 and
1402 respectively, will be altered to optimize the timing and
duration of dosing for RXI-109 in these indications.
"We are pleased to see that our early observations at 1-month
post scar revision surgery reported in September are confirmed by
our 3-month observations," said Dr. Geert
Cauwenbergh President and CEO of RXI Pharmaceuticals. He
added that, "Our work is obviously not done. The observations in
RXI-109-1301 in our target population with hypertrophic scars allow
us to fine tune the treatment schedules in the ongoing adaptive
protocols. Keeping in mind that the duration of
hyperproliferation is extended for hypertrophic scars and keloids,
we can adjust the treatment length to accommodate for that
variability factor."
About RXI-109 Clinical Trials
RXi Pharmaceuticals' first clinical program involves RXI‑109, an
sd-rxRNA® compound, developed for the reduction of
dermal scar formation. RXI‑109 is designed to reduce the expression
of connective tissue growth factor (CTGF), a critical regulator of
biological pathways involved in fibrosis, including scar formation
in the skin. The first clinical trials with RXI‑109 (RXI-109-1201
and RXI-109-1202) showed excellent safety and tolerability with
ascending single and multiple doses, as well as dose-dependent
effects on the CTGF protein and on the mRNA that controls
production of this protein.
In November 2013, the Company
started its first Phase 2a study (RXI-109-1301) in patients who had
pre-existing hypertrophic scars present on their lower abdomen for
at least one year. In that study, the patients undergo scar
revision surgery, after which they are treated with RXI-109 on one
end of the scar and placebo on the opposite end of the scar. This
study is ongoing but has completed enrollment. In April of this
year, the Company began its second Phase 2a study (RXI-109-1401)
for RXI-109 treatment to prevent recurrence of keloids in patients
undergoing keloidectomy (removal of keloid). Patients with two
keloids of similar size and location are eligible for the study.
After keloidectomy, the lesions are closed and one is treated with
RXI-109, and the other is treated with placebo. As is the case for
the study in hypertrophic scars, patients will be followed for
several months (clinically and with photographs) after the end of
treatment.
The Company's third Phase 2a study (RXI-109-1402) was initiated
in July 2014 for RXI-109 for the
reduction of recurrence of hypertrophic scars following elective
scar revision surgery. In this study, patients with either one long
hypertrophic scar, or two scars comparable in length, anatomical
location and characteristics, are eligible to receive scar revision
surgery. For a single scar, a portion of the revised scar
segment will be treated with RXI-109 and a comparably sized length
on the opposite end of the excised scar segment will be left
untreated. If two scars are revised, one revised scar segment will
be treated with RXI-109 and one scar will be left untreated after
revision surgery. This third Phase 2a study will follow patients
for nine months. Investigator and independent reviewer assessments
will be used to evaluate the effectiveness of RXI-109 in preventing
scar formation. Reviewers will evaluate and compare the appearance
of the revised areas after treatment with RXI-109 or when left
untreated.
All three Phase 2a trials incorporate a within-subject
comparison of revised sites treated with RXI-109 vs. control
sites. This is a powerful study design because it decreases
the potential impact of variability due to patient-to-patient
healing characteristics.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering, developing and
commercializing innovative therapies based on its proprietary,
self-delivering RNAi (sd-rxRNA®) platform. Therapeutics
that use RNA interference, or "RNAi," have great promise
because of their ability to down-regulate the expression of
specific genes that may be over-expressed in disease conditions.
Building on the pioneering work of scientific founder and Nobel
Laureate Dr. Craig Mello, a member
of the RXi Scientific Advisory Board, RXi's first RNAi product
candidate, RXI‑109, a self-delivering RNAi compound
(sd-rxRNA®), entered into human clinical trials in
June 2012 and is currently being
evaluated in Phase 2 clinical trials to reduce the formation of
dermal scars and keloids. RXI-109 is designed to reduce the
expression of connective tissue growth factor (CTGF), a critical
regulator of biological pathways involved in fibrosis, including
scar formation in the skin. RXi's sd‑rxRNA oligonucleotides
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. These
hybrid oligonucleotide molecules combine the beneficial properties
of conventional RNAi and antisense technologies. This allows
sd‑rxRNAs to achieve efficient cellular uptake and potent,
long-lasting intracellular activity. For more information, please
visit 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 future expectations, planned and future development of RXi
Pharmaceuticals Corporation's products and technologies.
Forward-looking statements about expectations and development plans
of RXi's products involve significant risks and
uncertainties: the risk that we may not be able to
successfully develop our candidates, or that development of
RNAi-based therapeutics may be delayed or not proceed as planned,
or that we may not develop any RNAi-based products; risks that the
development process for our product candidates may be delayed,
risks related to the development and commercialization of products
by our competitors, the risk related to our ability to control the
timing and terms of collaborations with third parties, and the
possibility that other companies or organizations may assert patent
rights preventing us from developing our products. Actual results
may differ from those contemplated by these 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rxi-pharmaceuticals-announces-sustained-effect-of-rxi-109-at-three-months-post-scar-revision-surgery-and-the-completion-of-enrollment-for-its-phase-2a-trial-rxi-109-1301-300010991.html
SOURCE RXi Pharmaceuticals Corporation