RXi Pharmaceuticals Announces Initiation of Second Double-Blind Vehicle Controlled Phase 1 Study With Its Anti-Scarring

  RXi Pharmaceuticals Announces Initiation of Second Double-Blind Vehicle
  Controlled Phase 1 Study With Its Anti-Scarring Compound, RXI-109

   New study evaluates safety, tolerability and scar outcome after multiple
             dosing with RXI-109 or vehicle in healthy volunteers

Business Wire

WESTBOROUGH, Mass. -- December 05, 2012

RXi Pharmaceuticals Corporation (OTC: RXII), today announced that dosing with
their anti-scarring drug, RXI-109, for the management of surgical and
hypertrophic scars and keloids has been initiated. Nine subjects (3 cohorts of
3) are participating in this dose escalation study during which intradermal
injections of RXI-109 will be administered on 3 occasions over 2 weeks. Dose
levels range from 2.5 to 7.5 mg per injection, and subjects will receive
injections of RXI-109 and vehicle at small incisions on separate areas of
their abdomen. Data on safety and tolerance will be collected and evaluated.
The incisions will also be evaluated for possible drug effects on the
scarring.

“We are pleased that, based on the excellent safety profile observed after
single dosing with RXI-109, we have been able to move this quickly from the
first into the second clinical study, which evaluates multiple doses per
subject,” said Dr. Geert Cauwenbergh, President and CEO of RXi
Pharmaceuticals. He added that, “The speed with which we have been able to
move this development forward is a testament to the safety of the drug, but
also to the dedication of the team that executes this project. If we can
continue at this pace, and assuming no unexpected hurdles, RXi Pharmaceuticals
should be able to move into its first Phase 2 studies with RXI-109 in the
second half of 2013.”

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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