MARLBOROUGH, Mass.,
July 30, 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 their
third Phase 2a study (RXI-109-1402) with RXI-109, for the reduction
of recurrence of hypertrophic scars following elective scar
revision surgery, has been initiated.
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In this study (RXI-109-1402), 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, a portion of one revised scar
segment will be treated with RXI-109 and one scar will be left
untreated after revision surgery.
"The Company continues to deliver against its projected
corporate milestones with the initiation of this third study," said
Dr. Geert Cauwenbergh, President and
CEO of RXi Pharmaceuticals. He added that, "This study is another
step forward to bringing our self-delivering (sd-rxRNA®)
RNAi technology closer to market. We are very excited by everything
we have been able to achieve with our compounds, thus far, and we
look forward to providing further updates in the near future."
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.
This design allows for intra-subject comparison thereby increasing
the power of the study.
About RXI-109 Clinical Trials
RXi Pharmaceuticals' first clinical program involves RXI‑109, an
sd-rxRNA compound, developed for the reduction of dermal scarring.
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 in that study, who have two keloids of similar size and
location, are selected for keloidectomy. After this procedure, 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.
About Hypertrophic Scars and Keloids
Hypertrophic scars are abnormal scars that are raised
above the normal skin surface and can be reddened or darker than
the existing skin tone. These scars result in part from an
increased level of collagen and are less "elastic" than the
surrounding skin. Hypertrophic scars remain confined to the
original surgical incision line or site of injury. The
incidence of hypertrophic scarring (raised, thickened scars)
following surgery is reported to be at least 40% in the general
population and up to 70% in certain Asian populations.
Keloids are also raised and reddened or darkened scars
resulting from increased collagen production, but keloids often
spread beyond the original site of skin injury and may continue to
grow in size. Keloids can result from skin "trauma" as common
as an ear piercing or vaccination and may grow to cover large
areas. Keloids are sometimes removed by surgical revision,
but recurrence rates are as high as 50-80%. Keloids are most
prevalent in darker skinned individuals, up to 16% in people of
African ancestry, and 50% of all keloid patients have a family
history of keloids.
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 dermal scarring
(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