MARLBOROUGH, Mass.,
May 18, 2018 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company
developing the next generation of immuno-oncology therapeutics
based on its proprietary self-delivering RNAi (sd-rxRNA®)
therapeutic platform, today announced the positive results of its
Phase 2 clinical trial, RXI-SCP-1502. This study evaluated the
safety and effectiveness of Samcyprone™, a proprietary topical
formulation of the small molecule diphenylcyclopropenone (DPCP),
for the treatment of common warts.
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The primary effectiveness objectives were met as shown by high
levels of immunotherapeutic response and therapeutic response. The
immunotherapeutic response rate – a prerequisite for therapeutic
response – was 97.7% across all 88 subjects enrolled in the study.
From a therapeutic response viewpoint, with once weekly dosing for
up to 10 weeks, more than 70% of all warts showed a positive wart
response rate, i.e. reduction of wart size of more than 50%.
Complete wart clearance throughout the study was 54.0% for all
warts, and up to 71.4% for certain wart types (non-plantar warts).
The study results show furthermore that the product was safe
and well tolerated.
Gerrit Dispersyn Dr. Med. Sc., RXi's Chief Development Officer
commented: "We are very pleased with these results, as they are a
significant improvement over currently used treatment options.
Based on published meta-analyses of randomized clinical studies, we
know that the mean wart cure rate for placebo is around 23%, and it
is not much higher for daily use of topical salicylic acid for 3 to
6 months, which is currently the recommended first-line therapy. In
contrast, once weekly treatments with Samcyprone were used in our
study, and of the warts that cleared, most did so within the first
10 weeks of treatment. Therefore, our results suggest better and
faster results while requiring significantly fewer product
applications. In addition, for salicylic acid treatments, it is
recommended that lesions are abraded or pared down and/or soaked
prior to application. In our Samcyprone study there was no such
requirement for wart lesion preparation, which otherwise may have
resulted in even better wart clearance rates. In addition to the
key study objective, we collected a great amount of data that will
help with the design of pivotal studies in support of Samcyprone's
future marketing applications."
Dr. William Levis, Chairman of
the Foundation for Global Skin Health Strategies and Consultant to
the Laboratory of Investigative Dermatology at Rockefeller University added: "Compounded DPCP in
acetone has been used for many years by dermatologists with
demonstrated efficacy in numerous publications, but with highly
variable results due to compounding variability and poor handling
characteristics of the resulting solution. Based on the
exciting study results with this new proprietary formulation of
DPCP, I believe that Samcyprone will offer patients not only a
powerful new treatment option, but also one that is more patient
friendly than pharmacy compounded products and other currently used
treatments that require more frequent applications and longer
treatments."
This study was a multi-center, multi-dose trial conducted in
subjects with at least one cutaneous, plantar or periungual wart
present for at least four weeks. In this Phase 2 trial, subjects
were first treated with a sensitization dose on the inner arm and
one or more preselected wart lesion(s). Once the sensitization
response was confirmed, subjects continued with weekly treatments
for up to 10 weeks, followed by an optional extension phase of up
to another 10 weeks of weekly treatments. Two treatment cohorts
were evaluated, the main difference between the cohorts was the
amount of study product applied to the warts (more in Cohort 1).
Wart clearance was evaluated based on wart measurements over time
during the treatment period.
Overall Efficacy Results
- Immunotherapeutic response: Of the 88 subjects enrolled in the
study, 85 received at least one sensitization dose of 0.4% DPCP
ointment, and a positive immunotherapeutic response was observed in
all but 2 subjects (one in each cohort), overall resulting in a
97.7% success rate of 0.4% DPCP ointment in eliciting the required
immunotherapeutic response.
- Wart response rate: The total number of wart lesions in the per
protocol population (PP) was 87. Already during the first 10 weeks
of weekly treatments, a significant number of warts had a positive
response to the treatment, i.e. displayed a ≥50% reduction in wart
size. The overall wart response rate at that time was 70.1%, and
for non-plantar warts the overall response rate during the first 10
weeks was 81.0%.
- Wart clearance rate: Complete clearance (PP) during the first
10 weeks of treatment was seen in 43.7% of all warts. Throughout
the full course of the study, 47 warts (54.0%) achieved complete
clearance. More non-plantar wart lesions, compared to plantar wart
lesions, achieved complete clearance: Clearance rate of non-plantar
warts lesions was the highest in Cohort 1 (57.1% during first 10
weeks, 71.4% after complete study).
- Safety and tolerability: Treatment with Samcyprone was well
tolerated in both treatment arms. There were no drug related
serious adverse events (SAEs), nor any dose limiting toxicities and
most adverse events (AEs) were those expected to be seen with a
topical immunomodulator, such as local reaction due to the
sensitization and challenge responses in the skin.
Presentation of RXI-SCP-1502 at the International
Investigative Dermatology Conference (IID)
The Company will present a poster presentation today from its
Phase 2 clinical trial, RXI-SCP-1502, with Samcyprone™.
Title: Samcyprone™
(diphenylcyclopropenone ointment) for the Treatment of Common
Warts
Date and Time: Friday, May 18,
2018, 12:00 pm – 2:00 p.m.
Session: Clinical Research, Pathophysiology and
Therapeutics
Poster #: 490, Gatlin Ballroom
Two additional posters were also presented at this
conference:
- RXI-109 Treatment to Reduce the Formation of Hypertrophic
Dermal Scars
- Topical Administration of self-delivering RNAi (sd-rxRNA)
Compounds for the Reduction of Hyperpigmentation
Each of the three posters may be found on the Company's website:
http://investors.rxipharma.com/events-and-presentations/posters
The IID Conference unites three leading dermatology societies,
the European Society of Dermatological Research (ESDR), the Journal
of Investigative Dermatology (JSID) and the Society of
Investigational Dermatology (SID), into one meeting that takes
place every five years. The 2018 IID will hold its seventh
meeting this year, where scientists and industry leaders gather
from across the world to exchange information and facilitate
collaboration. This meeting is being held May 16-19, 2018 at Rosen Shingle Creek Resort in
Orlando, Florida.
About Samcyprone™ and RXI-SCP-1502
In 2015, the Company completed an exclusive global license to
Samcyprone™ from Hapten Pharmaceuticals, LLC. After the transfer of
the IND to RXi, the Company completed a process to optimize the
topical formulation (Samcyprone™) followed by the initiation of its
Phase 2 study, RXI-SCP-1502. Samcyprone™ is being
studied for the treatment of cutaneous warts, which are benign
epidermal tumors caused by human papillomaviruses (HPVs). They are
extremely common, being experienced by most people at some time
during their lives. More than 22 million people in the United States suffer from common warts,
and approximately 1.9 million people are diagnosed with common
warts annually. There are currently no FDA approved prescription
products for the treatment of common warts.
About RXi's Dermatology Franchise
RXi announced in January 2018 that it would
exclusively focus on developing the next generation of
immuno-oncology therapeutics based on its self-delivering RNAi
therapeutic platform. As such, it is actively seeking to
partner or out-license both its Dermatology and Ophthalmology
Franchises.
Each of these Franchises is comprised of a number of preclinical
and clinical-stage assets broadly covered by a robust intellectual
property estate. To obtain more information about these assets,
contact RXi's Director of Business Development, Dr. James
Cardia at jcardia@rxipharma.com
About RXi Pharmaceuticals
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company developing the next generation of
immuno-oncology therapeutics based on its self-delivering RNAi
(sd-rxRNA®) therapeutic platform. The Company's discovery and
research efforts are focused on developing sd-rxRNA therapeutic
compounds to be used with an Adoptive Cell Transfer (ACT) approach.
This process uses immune cells, such as T-lymphocytes that are
isolated from the patient or retrieved from allogeneic immune cell
banks, and then expanded and in some cases processed to express
tumor-binding receptors. Our approach introduces a new and
important step in ex-vivo processing of the immune
cells where sd-rxRNA is used to eliminate the expression of
immunosuppressive receptors or proteins from the therapeutic immune
cells, making them less sensitive to tumor resistance mechanisms
and thus improving their ability to destroy the tumor cells.
Essentially, we aim to maximize the power of our sd-rxRNA
therapeutic compounds by weaponizing therapeutic immune effector
cells to attack cancer and ultimately provide patients battling
terminal cancers with a powerful new treatment option that goes
beyond current treatment modalities.
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 expectation regarding closing of the offering, our
ability to successfully develop RXI-109, Samcyprone™, RXI-762,
RXI-804 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.
Contact RXi Pharmaceuticals
Corporation
Tamara
McGrillen
Tel: +1 508-929-3646
Email: tmcgrillen@rxipharma.com
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SOURCE RXi Pharmaceuticals Corporation