LA JOLLA, Calif., Jan. 7, 2019 /PRNewswire/ -- Regulus Therapeutics
Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on
the discovery and development of innovative medicines targeting
microRNAs, today announced the nomination of RGLS5579 as a clinical
candidate for the treatment of glioblastoma multiforme
("GBM").
As recently disclosed at a scientific meeting, a single dose of
RGLS5579 demonstrated increased survival as monotherapy vs. control
in an orthotopic GBM animal model (18% increase in median survival
vs. control) and in combination with temozolomide, a single dose of
RGLS5579 significantly increased median survival (159% increased
median survival vs. control; p = 0.0001). Standard of care
temozolomide as a single agent increased median survival by 27% vs.
control, therefore the combination of RGLS5579 plus temozolomide
demonstrated synergistic efficacy in this model. RGLS5579 has
completed the clinical candidate screening process demonstrating
appropriate preliminary safety and drug-like properties.
"We are excited to announce our clinical candidate for the
treatment of GBM, a devastating form of brain cancer, for which
therapeutic options are extremely limited. The combination
data we have generated, and repeated, may suggest that we can
significantly extend expectations for survival for patients with
GBM over the current standard of care," said Jay Hagan, President and Chief Executive Officer
of Regulus. "RGLS5579 represents a novel approach to
targeting a microRNA that has been shown to be important for the
proliferation of GBM tumors."
About GBM
GBM is a highly malignant form of brain tumor. miR-10b is
highly expressed in all GBM molecular subtypes, and its expression
in normal brain cells is nearly undetectable. Its cells
reproduce quickly and are nourished by a large network of blood
vessels, fueling rapid growth and making it one of the most
aggressive forms of brain cancer. Because of its aggressiveness,
GBM is categorized as a high grade glioma (HGG). GBM is one
of the most common forms of HGG, with new diagnoses estimated to be
approximately 12,500 in 2018 in the
United States. It accounts for about half of all brain and
central nervous system cancers and is reported to have a five-year
survival rate of approximately five percent.
About RGLS5579
RGLS5579 is a novel oligonucleotide designed to inhibit
miR-10b. Preclinical studies with RGLS5579 have demonstrated
direct anti-tumor effects in vitro and in vivo. RGLS5579 was
selected from a library of over 200 anti-miRs targeting miR-10b
based on its potency, selectivity and safety profile. In an
orthotopic mouse model in which human GMB tumor cells were
implanted into the brains of immunocompromised mice, RGLS5579
increased median survival as a monotherapy, and markedly extended
median survival time in combination with TMZ.
About Regulus
Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical
company focused on the discovery and development of innovative
medicines targeting microRNAs. Regulus has leveraged its
oligonucleotide drug discovery and development expertise to develop
a pipeline complemented by a rich intellectual property estate in
the microRNA field. Regulus maintains its corporate
headquarters in La Jolla,
CA. For more information, please visit
http://www.regulusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements associated with the expected ability
of Regulus to undertake certain activities and accomplish certain
goals (including with respect to the advancement of RGLS5579 for
the treatment of glioblastoma multiforme), the projected timeline
of clinical development activities, , and expectations regarding
future therapeutic and commercial potential of Regulus' business
plans, technologies and intellectual property related to microRNA
therapeutics and biomarkers being discovered and developed by
Regulus. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as "believes," "anticipates," "plans," "expects," "intends,"
"will," "goal," "potential" and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon Regulus' current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation and risks associated with the process
of discovering, developing and commercializing drugs that are safe
and effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. These and other risks
concerning Regulus' financial position and programs are described
in additional detail in Regulus filings with the Securities and
Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made. Regulus undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
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SOURCE Regulus Therapeutics Inc.