MARLBOROUGH, Mass.,
March 23, 2015 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company
focused on discovering and developing innovative therapies
addressing high-unmet medical needs primarily in the area of
dermatology and ophthalmology, today announced at the annual
meeting of the American Academy of Dermatology in San Francisco, several significant
advancements within its dermatological programs.
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Today, Dr. Lyn Libertine, Vice
President Medical Affairs and Safety Assessment of RXi
Pharmaceuticals will present two poster presentations that will
provide an overview of the Company's first clinical compound,
RXI-109, a self-delivering RNAi (sd‑rxRNA®) compound currently
being evaluated in Phase 2a clinical trials. The first
presentation, "RXI‑109 Treatment to Reduce the Formation of Keloids
Following Keloidectomy," will be held today from 12:10 to 12:15 p.m. PDT. Keloids are a type of
abnormal scar that can result from skin trauma where collagen is
continuously 'layed' down during the proliferation phase of the
wound healing process and that grows beyond the boundaries of the
original wound. For keloids, versus normal scars, the proliferation
phase can continue for well over one year.
Enrollment has completed and data collection and analysis are
ongoing for study RXI-109-1401 in which the clinical effect of
RXI-109 treatment is being evaluated for its ability to reduce
recurrence of keloids following keloidectomy. The Company held a
meeting with an expert panel comprised of clinical advisors,
practicing dermatologists and plastic surgeons, including
investigators participating in this study. This panel conducted a
review of preliminary data from this study where treatment with
RXI‑109 was limited to only four weekly injections over a 1-month
period. The panel members looked at blinded pictures of the first
seven subjects for the first few months after treatment and more
often identified the placebo-treated site as showing faster
recurrence of the keloid. No major side effects or safety concerns
have been reported. Based on these preliminary clinical
observations, a reduced recurrence of keloids treated with RXI-109
as compared to placebo, this Clinical Advisory Panel provided a
unanimous recommendation to the Company to lengthen the treatment
regimen and to increase the number of doses with RXI-109 to reflect
the chronic and aggressive nature of the formation process of a
keloid. The Company will move forward with those recommendations
and initiate an additional keloid trial in the near
future.
Dr. Libertine's second poster presentation, "Update on Phase 2
Clinical Trial Results of RXI‑109 Treatment to Reduce the Formation
of Hypertrophic Dermal Scars", will be held today from 12:20 to 12:25 p.m. PDT. 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. Studies RXI-109-1301
and RXI-109-1402 are investigating the clinical effect of RXI-109
in reducing the recurrence of hypertrophic scar formation following
surgical scar excision. The Company has learned from RXI-109-1301
that initiating treatment with RXI-109 two weeks post scar revision
surgery is beneficial versus initiating treatment immediately. The
Company has also shown, in study 1301, that 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 1-month and 3-month follow-up more frequently than when
treatment was initiated immediately post scar revision surgery.
With the observations from study 1301, the Company's third Phase 2a
clinical trial, RXI-109-1402, was designed with an optimized dosing
regimen. Enrollment has completed in study 1301 and subjects will
continue to be monitored. Subjects in Study 1402 have entered on a
rolling basis and enrollment is more than 50% complete.
Dr. Libertine's poster presentations will be at the
73rd Annual Meeting of the American Academy of
Dermatology. This meeting features world-renowned leaders
presenting the latest research in the diagnosis and medical,
surgical and cosmetic treatment of skin, hair and nail conditions
and will be held at The Moscone Center in San Francisco, CA. Both presentations
will be at the Center E‑Poster Presentation, Center 3, in the Wound
Healing and Ulcers section. The posters will be available on the
Company's website at www.rxipharma.com approximately one hour after
the presentation.
Dr. William Levis, Lifetime
Professor of Dermatology at Rockefeller
University and co-developer of Samcyprone™, presented a
poster on Sunday, March 22, 2015 at
the American Academy of Dermatology, "Diphencyprone for the
Treatment of Dermatological Disorders with an Immunological
Component". Samcyprone™ is a proprietary topical immunomodulating
formulation containing the active agent diphencyprone (DPCP). RXi
Pharmaceuticals recently closed an exclusive global license to
Samcyprone™ in February 2015. The
Company is currently evaluating next steps for Samcyprone™ and
expects to initiate a second Phase 2a clinical trial for the
treatment of warts by the end of 2015. Dr. Levis' presentation and
additional information on Samcyprone™ may be found on the Company's
website, www.rxipharma.com.
The Company also announced today that it has entered into a
collaboration with Dr. James Krueger
of The Rockefeller University for the
study of the effects of Samcyprone™ on the changes in gene
expression profiles influenced by diphencyprone in patients with
cutaneous metastases of solid tumors treated with our product. In
addition to being of high clinical relevance to patients who suffer
from these metastases, this collaborative effort may lead to the
identification of proteins that could be good targets for novel
potent and selective RNAi compounds based on our sd-rxRNA® delivery
platform. James G. Krueger
M.D. Ph.D. is the D. Martin Carter Professor in Clinical
Investigation and he serves as the Director of the Milstein Medical
Research Program, which conducts new clinical studies of the
pathogenesis of melanoma and other pigmentory diseases at
The Rockefeller University Hospital in
New York, NY.
(http://www.rockefeller.edu/research/faculty/labheads/JamesKrueger/)
The Company has also entered into a collaboration with Dr.
Maria Hordinsky of the University of Minnesota and the National Alopecia
Areata Foundation (NAAF) for the study of Samcyprone™ in the
treatment of alopecia areata, with the aim to optimize the
treatment regimen of diphencyprone is this dermatological disorder,
and to better understand the mechanism of action of the drug in
this disease. This collaboration could lead to novel targets for
development of potent RNAi compounds against this disease based on
our sd-rxRNA® platform. Maria K.
Hordinsky, M.D. is Professor and Chair of the Department of
Dermatology at the University of Minnesota,
Twin Cities campus. Dr. Hordinsky is the current president
of the Association of Professors of Dermatology, Chair of the
Clinical Research Advisory Council of the National Alopecia Areata
Foundation and is Secretary/Treasurer of the North American Hair
Research Society.
(http://www.dermatology.umn.edu/meet-our-faculty/maria-hordinsky/index.htm)
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering and developing
innovative therapeutics addressing high-unmet medical needs,
primarily in the area of dermatology and ophthalmology. Our
discovery and clinical development programs are based on siRNA
technology as well as immunotherapy agents. These compounds
include, but are not limited to, our proprietary, self-delivering
RNAi (sd-rxRNA®) compounds for the treatment of dermal
and retinal scarring. It also includes an immunomodulator,
Samcyprone™, a proprietary gel formulation of
diphenylcyclopropenone (DPCP), for the treatment of such disorders
as alopecia areata, warts, and cutaneous metastases of
melanoma.
RXi's robust pipeline, coupled with an extensive patent
portfolio, provides for product and business development
opportunities across a broad spectrum. We are committed to being a
partner of choice for academia, small companies, and large
multinationals. We welcome ideas and proposals for strategic
alliances, including in- and out-licensing opportunities, to
advance and further develop strategic areas of interest.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements include, but are not limited to, statements
about future expectations and planned and future development of our
product candidates, technologies and partnerships.
Forward-looking statements about expectations and development
plans of RXi's product candidates and partnerships involve
significant risks and uncertainties, including the following: risks
that we may not be able to successfully develop and commercialize
our product candidates; risks that product development and clinical
studies may be delayed, not proceed as planned and/or be subject to
significant cost over-runs; risks related to the development and
commercialization of products by competitors; risks related to our
ability to control the timing and terms of collaborations with
third parties; and risks that other companies or organizations may
assert patent rights preventing us from developing or
commercializing our product candidates. Additional risks are
detailed in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q under the caption "Risk
Factors." Readers are urged to review these risk factors and
to not act in reliance on any forward-looking statements, as actual
results may differ from those contemplated by our 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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