MARLBOROUGH, Mass, Dec. 22, 2014 /PRNewswire/ -- RXi
Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company
focused on discovering, developing and commercializing innovative
therapies addressing major unmet medical needs using RNA-targeted
technologies, today issued the following open letter to
shareholders from President & CEO, Geert Cauwenbergh, Dr. Med. Sc.
Dear RXi Shareholders,
In the past few days a number of inaccurate statements posted on
certain social media sites seem to have caused harm to our Company
and its shareholders. These inaccurate statements followed on
Friday, December 19th
after our announcement of our entry into an agreement to acquire
rights to a second Phase 2 asset. These third party
statements have caused concerns with our shareholders and have
seemingly negatively affected our share price that day. We wish to
dispel these rumors and address the misleading remarks head-on by
re-emphasizing how our recent activities are expected to contribute
to the future growth of our Corporation.
1. RXI-109 for hypertrophic
scars and keloids post scar revision surgery.
The Company's ongoing clinical trials with RXI-109 continue to
be on track. We issued a press release on December 17, 2014 announcing the completion of
enrollment in our first Phase 2a study, RXI-109-1301, and confirmed
that the preliminary results from the 3-month observations
confirmed the 1-month findings that were reported in September of
this year. The findings from these 1- and 3-month observations
provide preliminary evidence that RXI-109 may show clinical effect
in the target population (patients with hypertrophic scars), and
have provided clear guidance that it is best to start with RXI-109
treatment 2-weeks after the revision surgery, which is after the
acute inflammation phase that occurs as a result of the surgery.
Our other Phase 2a studies will implement this learning in an aim
to determine the optimal dose schedule and treatment length. This
type of approach, where studies subsequent to the initial evidence
of clinical effect attempt to define the optimal treatment schedule
is a standard approach in all drug development.
2. Samcyprone™, our
2nd product in the clinical pipeline:
In addition, we announced on December 19,
2014 an exclusive global license for Samcyprone™, a second
Phase 2 clinical compound. Samcyprone™ is a proprietary gel
formulation of diphenylcyclopropenone (DPCP), an immunomodulator
that works by initiating a T-cell response. We have several reasons
for adding this product to our clinical pipeline, which include the
following:
a. Many world class academic
dermatology centers use DPCP topically as an unregulated
experimental tool in alopecia areata, warts and cutaneous
metastases of malignant melanoma. This experience supports the
efficacy of DPCP as active ingredient and we expect has the
potential to significantly increase the likelihood of successful
clinical development of Samcyprone™ as a drug product. The target
diseases of Samcyprone™ complement the therapeutic areas in which
RXI-109 would become commercially available (dermatology), if
approved.
b. DPCP is a new chemical entity
under an investigational new drug application filed with the FDA in
the United States. Samcyprone™, the proprietary formulation
of DPCP, is expected to provide a favorable safety profile while
providing a consistent cGMP formulation.
c. Multiple synergies exist
between RXi's sd-rxRNA® platform and Samcyprone™. The mechanism of
action of Samcyprone™ is linked to DPCP's ability to alter the
expression of multiple genes and miRNAs involved in the immune
response. These gene targets may be modulated by an RNAi
approach, utilizing sd-rxRNAs, to further enhance
Samcyprone's™ efficacy and response rates. Additionally,
this approach may result in the discovery and development of
sd-rxRNA or other drugs that are more potent and selective for
treatment of alopecia areata, warts or cutaneous metastases of
malignant melanoma. Such developments, if successful, would be
expected to bolster our intellectual property portfolio as a result
of those new targets. Adding this new clinical-stage product
candidate to our clinical development effort is not an exit from
our core RNAi platform with sd-rxRNA. On the contrary, apart from
possibly being a nice commercial asset in the years to come, it
could also become an interesting research tool to enhance the value
of the sd-rxRNA platform through identification of new protein
targets for our RNAi compounds.
3. Misleading statements about
stagnation in our technology platform:
Contrary to allegations made in social media last week, our
recent announcement, as well as our earlier reports on our
ophthalmology franchise, with an ophthalmology IND to be submitted
for RXI-109 planned for Q2 2015, and the synthesis of potent
sd-rxRNA compounds against VEGF, collectively demonstrate that the
progress with our technology platform is far from stagnant. Add to
that our recent patent submissions on newly synthesized sd-rxRNA
compounds against collagenase and tyrosinase, and we feel that the
Company has made and continues to make a strong statement about the
value of the platform for the future of RXi Pharmaceuticals.
We can only hope that investors and shareholders who read blogs,
tweets and postings from third parties purporting to have an
informed view on our business will also do an in depth evaluation
of the background of those who write such "reports", their past
contributions to the actual progress in the RNAi space, and their
possible associations to competitors and other firms working in a
similar space. Notwithstanding these ill-informed criticisms, we
remain optimistic about the prospects of the Company and our core
technology.
Thank you for being an RXi Shareholder. We look forward to
continuing our progress and ongoing efforts to increase shareholder
value.
With kind regards,
Geert Cauwenbergh, Dr. Med. Sc.
President and CEO
RXi Pharmaceuticals Corporation
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
biotechnology company focused on discovering, developing and
commercializing innovative therapies based on its proprietary,
self-delivering RNAi (sd-rxRNA®) platform. Therapeutics that use
RNA interference, or "RNAi," have great promise because of
their ability to down-regulate the expression of specific genes
that may be over-expressed in disease conditions. 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, a self-delivering RNAi compound (sd-rxRNA), entered into
human clinical trials in June 2012
and is currently being evaluated in Phase 2 clinical trials to
reduce the formation of dermal fibrosis (e.g., hypertrophic scars
and keloids). RXI-109 is designed to reduce the expression of
connective tissue growth factor (CTGF), a critical regulator of
biological pathways involved in fibrosis, including scar formation
in the skin. 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. For more information, please
visit www.rxipharma.com.
Forward-Looking Statements
This communication 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, technologies and
partnerships. Forward-looking statements about expectations and
development plans of RXi's products and partnerships involve
significant risks and uncertainties such as: the risk that we
may not be able to successfully develop our 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
products; risks that the development process for our product
candidates may be delayed, risks related to the development and
commercialization of products by our competitors, the risk related
to our ability to control the timing and terms of collaborations
with third parties, 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 communication.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com
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SOURCE RXi Pharmaceuticals Corporation