MARLBOROUGH, Mass.,
Oct. 7, 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 that a review of the first two
enrolled patients' clinical photographs in the first Phase 2a
clinical trial (RXI-109-1301), indicate that treatment with the
Company's lead clinical candidate, RXI-109, may be effective in
suppressing recurrence of hypertrophic scars at the 3-month time
point. Patients will continue to be monitored through 9 months to
evaluate if this outcome persists over time.
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On September 10th of
this year, the Company announced that based on early 1-month
observations, the dosing regimen in these trials can be fine-tuned,
allowing the Company to more rapidly move forward with treatment
optimization for the prevention of scarring after surgery. Today's
presentation will provide 3-month photographs from the first two
patients enrolled in study RXI-109-1301 that indicate treatment
with RXI-109 shows a clinical benefit. The safety information in
this ongoing study to date, continues to confirm that RXI-109 is
well tolerated with no overt systemic side effects. Local
effects are mild and similar to those seen in the Company's prior
Phase 1 clinical trials (erythema, occasional, transient burning or
stinging sensation). Complete 3-month results from this trial are
expected to be available in Q1 2015.
"We are encouraged by the preliminary results in this trial,"
said Dr. Geert Cauwenbergh,
President and CEO of RXi Pharmaceuticals. "To date, our Phase 2a
studies are providing us with exactly the information for which
such studies are intended, early information on dosing requirements
and observation of a clinical effect of the drug. Having this
information in hand now should save money and time going forward in
our clinical development as we will incorporate these learnings
into future clinical protocols."
The presentation will be webcast today, Tuesday, October 7, 2014 at 10:00 a.m. PST, at the 13th Annual BIO
Investor Forum. The webcast will be available on the "Investors"
section of the Company's website, www.rxipharma.com.
About the BIO Investor Forum
The 13th Annual BIO Investor Forum is an
international investor conference focused on private and emerging
public biotech companies. This Forum also draws business
development executives from leading global pharmaceutical and
established biotechnology companies. The meeting will take place
October 7-8, 2014 at the Palace Hotel
in San Francisco, California.
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.
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 (fibrosis). 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
SOURCE RXi Pharmaceuticals Corporation