RXi Pharmaceuticals Announces Completion of Enrollment in Second Phase 1 Trial for RXI-109 Program

  RXi Pharmaceuticals Announces Completion of Enrollment in Second Phase 1
  Trial for RXI-109 Program

Business Wire

WESTBOROUGH, Mass. -- January 30, 2013

RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused
on discovering, developing and commercializing innovative therapies addressing
major unmet medical needs using RNA-targeted technologies, today announced
that its second Phase 1 study with their anti-scarring drug, RXI-109, for the
management of surgical and hypertrophic scars and keloids, has been fully
enrolled. This multi-dose study administers 3 intra-dermal injections over a
two week period, in a dose ascending manner, with each subject receiving both
active and placebo on a double blind basis. This second study not only
evaluates safety/tolerance parameters and systemic exposure to the drug but
also measures mRNA levels of CTGF and various other biomarkers considered
relevant for wound healing and scarring.

“The completion of enrollment for this study has happened well within the
projected time frame,” said Dr. Geert Cauwenbergh, President and CEO of RXi
Pharmaceuticals. He added that, “The safety profile of RXI-109, continues to
be excellent, and the Company hopes to extract valuable information from these
studies that will contribute to the design of our Phases 2a studies in terms
of dose and treatment frequency.”

About Scarring

Skin scarring after surgery, trauma, or burns can cause debilitating
aesthetic, functional and psychological effects. There are no FDA-approved
therapeutics for treatment of post-operative scars. RXI-109 has been shown in
preclinical models to reduce CTGF, a growth factor essential in the wound
healing cascade. Elevated levels of CTGF-dependent signaling can prolong the
tissue repair process and lead to pathological scarring.

About RXI-109

RXi Pharmaceuticals’ first clinical program involves RXI-109, a
self-delivering RNAi compound (sd-rxRNA®) developed for the reduction of
dermal scarring. RXI-109 is designed to reduce the expression of CTGF, a
critical regulator of biological pathways involved in fibrosis, including scar
formation in the skin. The first clinical trial of RXI-109 has shown excellent
safety and tolerability with ascending single doses. This second trial uses
multiple doses and evaluates safety and side effects of these doses, while
also exploring possible effects of RXI-109 on the healing process.

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.

About RXi Pharmaceuticals Corporation

RXi Pharmaceuticals Corporation (OTC: RXII) is a biotechnology company focused
on discovering, developing and commercializing innovative therapies based on
its proprietary, self delivering RNAi platform. Therapeutics that use RNA
interference, or “RNAi,” have great promise because of their ability to
down-regulate, the expression of a specific gene that may be over-expressed in
a disease condition. 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, which targets CTGF, entered into
human clinical development in June 2012. 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: risks
that RXi may not be able to successfully develop its 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 product; risks that the
development process for our product candidates may be delayed, risks related
to development and commercialization of products by our competitors, risks
related to our ability to control 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
 
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