MARLBOROUGH, Mass.,
Dec. 18, 2017 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company
developing a new class of RNAi-based therapeutics today announced
positive results with its lead clinical compound RXI-109 in a Phase
2 clinical trial. RXI-109-1402 is an open-label, multi-center,
prospective, within-subject controlled study evaluating the
effectiveness and safety of RXI-109 on the outcome of scar revision
surgery for hypertrophic scars in healthy adults. The primary
effectiveness objective was met as shown by a statistically
significant improved visual appearance of revised scars after scar
revision surgery and treatment with RXI-109 versus control, as
assessed by the investigator. The full study results show that the
product was safe and well tolerated for all dosage groups.
Exploratory endpoint analysis furthermore shows that the cosmetic
outcomes of RXI-109 treated scars were highly preferred over the
untreated revised scars, by both investigators and
patients.
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Joseph P. Hunstad, MD, FACSA,
member of the Board of Directors for the American Society for
Aesthetic Plastic Surgery and a Principal Investigator for the
Company's Dermatology Clinical Program with RXI-109 stated that:
"Today, scarring represents a high unmet medical need and based on
our results; I believe that RXI-109 offers a clinically meaningful
benefit for the treatment and prevention of hypertrophic scars
following scar revision surgery. I look forward to providing
further guidance in the development of this exciting new treatment
option."
RXi's Chief Development Officer, Gerrit
Dispersyn, Dr. Med. Sc., commented: "These results are very
exciting, as they provide us with strong evidence that RXI-109, by
preventing the overexpression of connective tissue growth factor,
can result in a positive impact on the prevention of hypertrophic
scars. The robustness of the data is shown by the fact that the
effect of RXI-109 was significant by using both validated detailed
scoring techniques, as well as simple qualitative assessments, and
by the investigator driven data being further corroborated by an
analysis of patient preferences. The fact that RXI-109 resulted in
statistically significant improvements on scar outcomes at all
follow-up time points for one of the dose groups, show that the
effect of RXI-109 is both observed early on, and lasts at least
throughout the entire follow-up time frame. In this study, we
collected a lot of information that will allow us to perform
additional analyses. Based on the current per protocol
analysis, RXI-109 can be confidently moved to the next phase of
clinical development."
Overall Efficacy Results
- Using the Investigator Scar Assessment Scale, which enables a
structured clinical evaluation of scar quality, the difference
between RXI-109 treated scars and untreated (control) scars, was
statistically significant at all follow-up time points, for one of
the treatment arms. The improvement over untreated scars was a mean
6.88 point change at 3 months (p=0.028), a mean 8.00 point change
(p=0.013) at 6 months and a mean 7.53 point change (p=0.013) at 9
months post revision surgery. The Investigator Scar Assessment
Scale is a validated scoring tool which accounts for several
parameters including surface area, pliability, relief, thickness,
pigmentation and vascularity.
- Using a qualitative measure of overall scar appearance
(visual-analog-scale), the difference noted by the Investigator was
also statistically significant for all follow-up time points, for
the same treatment arm. The improvement over untreated scars was a
mean 1.58 point change at 3 months (p=0.012), a mean 1.89 point
change (p=0.004) at 6 months and a mean 1.55 point change (p=0.017)
at 9 months post revision surgery.
- As an exploratory endpoint, patient reported outcome for scar
ranking was evaluated. Patients were asked to answer which scar
segment (A or B) looks 'better' or if they thought they were 'not
different'. For the treatment arm mentioned above, 88% of the
patients and 86% of the investigators preferred the RXI-109 treated
scar.
Safety and tolerability
- Treatment with RXI-109 was well tolerated in treatment arms.
There were no drug-related serious adverse events (SAEs) and most
other treatment emergent adverse events (AEs) were those commonly
found with intradermal injections, such as injection site pain
(17.4%), and injection site erythema (11.8%).
Additional details from the Phase 2 study will be submitted for
presentation at a future scientific conference.
Approximately 42 million surgeries occur in the United States alone each
year.1 The American Society of Plastic
Surgeons state that more than 170,000 patients receive scar
revision therapy annually.2 Based on these populations,
with costs primarily shouldered by patients, given the
non-life-threatening nature of these indications, the resulting
market potential could be worth as much as $1.5 billion. Given the current cost for
cosmetic therapies such as Botox® and the fact that there are
currently no approved treatment options for the prevention of
hypertrophic scarring, premium pricing could be achieved with
significant market penetration. Based on the study results, we are
one step closer to having RXI-109 become the first solution for the
prevention of hypertrophic scar formation in patients undergoing
surgery or traumatic injury.
RXI-109 and RXi's sd-rxRNA technology platform are broadly
protected in the United States and
International regions. The Company's robust patent estate
provides for multiple commercial and business development
opportunities.
About Dr. Joseph
Hunstad
Dr. Hunstad is one of the Principal Investigators for the
Company's dermatology clinical program with RXI-109. His site has
treated a large number of the subjects in the Company's clinical
trials with RXI-109 to date. He received his Doctor of
Medicine degree from the College of Human Medicine at Michigan State University and completed a General
Surgery residency at Butterworth Hospital in Grand Rapids. He completed his Plastic Surgery
residency at the Grand Rapids Area Medical Education Center, where
he later served as Plastic Surgery Chief Resident for a year. He
completed a Fellowship in Reconstructive Microsurgery at the MECOM
Microsurgical Institute in Houston
and is licensed to practice in North
Carolina, Michigan, and
Texas. Dr. Hunstad has been named
one of the Best Plastic Surgeons in America by Castle Connolly,
among numerous other awards and distinctions. Dr. Hunstad currently
serves on the Board of Directors for the American Society for
Aesthetic Plastic Surgery.
About RXi's self-delivering RNAi (sd-rxRNA) technology
platform
sd-rxRNA, RXi's proprietary self-delivering RNAi platform, is a
single chemically modified compound with delivery and therapeutic
properties built directly into the compound itself. The compound is
asymmetrical with a phosphorothioate backbone and contains chemical
modifications that provide for efficient cellular uptake and gene
silencing. These compounds are potent, stable and specific, and
demonstrated to be safe and active in a clinical setting.
RXi's novel sd-rxRNA technology differs from natural and most
synthetic RNA interference (RNAi) molecules in that they are
chemically modified to allow for efficient internalization of the
compounds by cells and silencing of the targeted genes.
Importantly, unlike other naked siRNA compounds, delivery of
sd-rxRNAs are not limited to a specific cell type. For local
delivery and ex vivo cell-based therapeutic applications, our
compounds do not require delivery vehicles. This is a major
advantage, since delivery vehicles can have related toxicity that
affects cell viability. sd-rxRNA has demonstrated nearly 100
percent transfection efficiency with high cell viability in
numerous cell types.
About RXi Pharmaceuticals
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage company developing innovative therapeutics that
address significant unmet medical needs. Building on the
pioneering discovery of RNAi, scientists at RXi have harnessed the
naturally occurring RNAi process which can be used to "silence" or
down-regulate the expression of a specific gene that may be
overexpressed in a disease condition. RXi developed a robust
RNAi therapeutic platform, including self-delivering RNA
(sd-rxRNA®) compounds, that have the ability to highly selectively
block the expression of any target in the genome, thus providing
applicability to many therapeutic areas. Our current programs
include dermatology, ophthalmology, and cell-based
immunotherapy. RXi's extensive patent portfolio provides for
multiple product and business development opportunities across a
broad spectrum of therapeutic areas, and we actively pursue
research collaborations, partnering and out-licensing opportunities
with academia and pharmaceutical companies. For additional
information, visit the Company's website,
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: our ability to successfully develop RXI-109, Samcyprone™ and
our other product candidates (collectively "our product
candidates"); the future success of our clinical trials with our
product candidates; the timing for the commencement and completion
of clinical trials; our ability to enter into strategic
partnerships and the future success of these strategic
partnerships; and our ability to deploy our sd-rxRNA® technology
through partnerships, as well as the prospects of these
partnerships to provide positive returns. 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.
1 Sund B. New Developments in Wound Care. PJB
Publications; London: 2000. pp.
1–255.
2
https://www.plasticsurgery.org/news/press-releases/14-million-cosmetic-plastic-surgery-procedures-performed-in-2012
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SOURCE RXi Pharmaceuticals Corporation