MARLBOROUGH, Mass.,
Dec. 13, 2016 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII), a
clinical-stage company developing innovative therapeutics that
address significant unmet medical needs, today provided an update
on its business development initiatives and ongoing clinical
programs.
- Business Development – Option to Acquire
MirImmune: RXi recently announced an option to acquire
MirImmune and we are working towards completing this
transaction. MirImmune has provided new data to RXi
demonstrating silencing of a number of undisclosed
immunosuppressive targets in natural killer cells (NK cells) using
RXi's sd-rxRNA® compounds. This adds to a remarkable set of
immune checkpoint modulation studies in human T cells, including
CAR-T cells and tumor Infiltrating lymphocytes (TILs).
- Clinical trial RXI-109-1402: Confirmed efficacy and
safety of RXI-109 to reduce the formation of hypertrophic scars
after scar revision surgery.
- Clinical trial RXI-109-1501: Announced
that enrollment is ahead of schedule in this Phase1/2 study
evaluating treatment with RXI-109 to reduce the formation of
subretinal fibrosis in patients with wet AMD to preserve vision for
a longer period of time. To date, RXI-109 has been well
tolerated with no safety issues that precluded continuation of
dosing.
- Clinical trial RXI-SCP-1502: Completed enrollment in the
first cohort evaluating Samcyprone™ for the treatment of cutaneous
warts. The first results in this study will be used to
optimize the treatment schedule (lower drug concentration and/or
shorter treatments) in future studies.
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"We are pleased and excited with the results that have been
generated over the course of this year in our business development
and clinical programs," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals. He
added that, "As stated throughout this press release, you will see
that we have continued to advance our clinical programs according
to projected timelines and remain on track for final readouts
during 2017. In fact, new data in the RXI-109 dermal trial
confirm and extend the 3-month data previously reported for
subjects treated with 5 mg/cm and indicate a positive effect of
RXI-109 out to 6 months after the last dose. In addition, we look
forward to completing the proposed MirImmune transaction that will
allow the integration of our self-delivering RNAi compounds into a
new therapeutic area. sd-rxRNA has the potential to become a
key component in the rapidly expanding field of cellular
immunotherapy, in what may be a transformational change in the way
we treat patients with various malignancies, including solid
tumors."
Business Development – Option to Acquire MirImmune:
Recently MirImmune has provided new data demonstrating silencing of
a number of undisclosed immunosuppressive targets in natural killer
cells (NK cells) using RXi's sd-rxRNA compounds. This adds to
a remarkable set of immune checkpoint modulation studies in human T
cells, including CAR-T cells and tumor Infiltrating lymphocytes
(TILs). In most cell types, the sd-rxRNA treatment results in
potent silencing while maintaining close to 100% transfection
efficiency and nearly full cell viability. Moreover, the
silencing effect has been validated in a number of clinically used
cell treatment protocols. The acquisition of MirImmune is the
first step into the field of cell-based therapies for RXi where its
sd-rxRNA platform has numerous advantages over other RNAi
technologies.
RXI-109-1402 – Hypertrophic Scarring: The first two
cohorts in RXI-109-1402 (3-month treatment regimen) are complete
and a blinded assessment of paired clinical photographs taken at 3,
6 and 9 months has been conducted. These data, based on 14
reviewers resulting in a data set of ~1,200 observations, confirm
the positive differentiation from untreated surgery incisions in
hypertrophic scars previously presented for a subset of subjects
treated with 5 mg/cm RXI-109 at 3 months. In addition, these
data extend this observation to all time points, including the
post-treatment follow-up period through 9 months
post-surgery. Given the choices of whether one scar was
better, not different from or worse, than its paired scar, the
reviewers selected the RXI-109 treated sites as better >60% of
the time at all time points and remarkably this differentiation was
maintained even at 6 months after the last dose. RXI-109 was
safe and well tolerated, with adverse events being typical to the
healing process following scar revision surgery and intradermal
injections, including mild to moderate redness, pain and
tenderness. There were no RXI-109-related serious adverse
events.
In the second half of the study, two cohorts were added to
evaluate a 6-month treatment regimen. As compared to six
doses in Cohorts 1 and 2, these cohorts include either nine doses
(Cohort 3) or eight doses (Cohort 4). As expected, the
limited 3-month data available from Cohort 3 appear to align with
that of Cohorts 1 and 2 as these subjects all had the same dosing
schedule through month 3. A complete read-out of the whole
study including all four cohorts with follow-up until 9 months
post- surgery is expected in the middle of 2017. At that time
the complete data set will include conclusions based on scar
evaluations from the principal investigators, demographics, and
comparisons across cohorts and times.
RXI-109-1501 – Retinal Scarring in Advanced Age-related
Macular Degeneration: The first two cohorts in
RXI-109-1501 are completely enrolled and dosing in the
3rd cohort at the highest planned dose level has
begun. Subjects in this study receive four intraocular doses
of RXI-109 on a monthly basis followed by a 4-month observation
period, and to date there have been no safety issues that precluded
continuation of dosing. Complete enrollment is anticipated
for early in 2017, ahead of our original plan, with a complete
safety read out of the study in the second half of 2017.
RXI-SCP-1502 – Treatment of Cutaneous Warts: This
study has completed enrollment of its first cohort of subjects,
including the pharmacokinetic portion of this ongoing study. A
preliminary review of sensitization and wart clearance data from
the subset of subjects that have completed the 10-week treatment
phase of the study was performed. Results show that greater
than 90% of the subjects demonstrated a sensitization response, a
prerequisite to be able to develop a therapeutic response.
Additionally, more than 60% of the subjects responded to the
treatment by exhibiting either complete or greater than 50%
clearance of all treated warts with up to 10 weekly
treatments. Samcyprone™ treatment has been generally safe and
well tolerated with drug-related adverse events being most
typically expected local reactions due to the sensitization and
challenge responses in the skin. An additional cohort will be
added in January 2017 to evaluate an
optimized treatment/dosing regimen with a reduced initial
sensitizing dose applied to the inner arm and all warts which may
result in a more streamlined treatment phase. Whereas the
read-out of the first cohort data will happen in the first half of
2017, the complete readout of the final study is anticipated in the
second half of 2017.
Consumer / Functional Health Care: Efficacy and
toxicity testing in cell culture and skin equivalents has been
successfully completed for RXI-231, an sd-rxRNA that targets
tyrosinase, a key enzyme in melanin synthesis. RXi is
coordinating with a US clinical testing site to initiate human
testing in Q1 2017 and RXI-231 has been manufactured in sufficient
quantities to support this activity. In addition to
evaluating safety, the effect of RXI-231 on the appearance of skin
pigmentation will be assessed.
About RXi's Proprietary Self-delivering RNAi (sd-rxRNA)
Technology Platform
RXi's proprietary sd-rxRNA technology has many advantages over
its competitors in the RNAi space. Scientists at RXi have
designed chemically-modified RNAi compounds with improved drug-like
properties that are potent, stable and specific. These
proprietary compounds have built-in delivery properties and
therefore do not require a delivery vehicle for local therapeutic
applications. The enhanced properties of sd-rxRNA
include: efficient spontaneous cellular uptake, stability,
reduced potential for immune stimulation, and potent, long-lasting
intracellular activity. All cell types tested (primary,
neuronal and non-adherent) internalize sd-rxRNA compounds uniformly
and efficiently, resulting in potent and long lasting
silencing. sd‑rxRNA compounds have the ability to selectively
block the expression of any target in the genome providing
applicability to a broad spectrum of therapeutic areas.
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, the Company's discovery and clinical
development programs are based on its proprietary self-delivering
RNAi (sd-rxRNA®) platform and Samcyprone™, a small molecule topical
immunomodulator. Current clinical development programs include
RXI-109, an sd-rxRNA, for the treatment of dermal and ocular
scarring, and Samcyprone™ for the treatment of such disorders as
warts, alopecia areata, non-malignant skin tumors and cutaneous
metastases of melanoma. RXi's robust pipeline, coupled with
an extensive patent portfolio, provides for multiple product and
business development opportunities across a broad spectrum of
therapeutic areas. 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. Additional information may be found on
the Company's website, www.rxipharma.com.
Forward-Looking Statements
Except for the historical information contained herein, the
matters set forth in this press release, including statements
regarding the Company's plans or other expectations, goals,
objectives, strategies, timelines and legal matters are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including the risks and uncertainties associated with: risks that
the potential acquisition of MirImmune may not proceed; the actual
realization of anticipated benefits of the purchase of MirImmune;
risks related to our ability to control the timing of the purchase
of MirImmune; 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; risks that other
companies or organizations may assert patent rights preventing us
from developing or commercializing our product candidates and other
risks detailed from time to time in the Company's most recent
Annual Report on Form 10-K and other documents subsequently filed
with or furnished to the Securities and Exchange Commission. These
forward-looking statements are based on current information that
may change and you are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this filing, as actual results may differ from those
contemplated by our forward-looking statements. All forward-looking
statements are qualified in their entirety by this cautionary
statement, and the Company undertakes no obligation to revise or
update any forward-looking statement to reflect events or
circumstances after the date of this press release.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com
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SOURCE RXi Pharmaceuticals Corporation