LA JOLLA, Calif., April 7, 2014 /PRNewswire/ -- Regulus
Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company
leading the discovery and development of innovative medicines
targeting microRNAs, today announced that three abstracts will be
presented in poster presentation sessions during the American
Association for Cancer Research (AACR) Annual Meeting, which will
be held April 5-9, 2014 in
San Diego, CA. An oral
presentation will also be presented by Regulus' strategic alliance
partner, Sanofi. Data to be presented include preclinical studies
investigating the therapeutic potential of targeting microRNA-21
("miR-21") and microRNA-221 ("miR-221") for the treatment of
hepatocellular carcinoma ("HCC"), the most common form of liver
cancer, and biomarker discovery studies evaluating the
pharmacodynamics signature for assessing miR-221 inhibition and
microRNA expression in tumor tissues in mouse models of HCC.
Each poster, after the time of its presentation, can be accessed on
the investor relations page of Regulus' website,
http://ir.regulusrx.com/
- Poster Session on miR-221 - April 7,
2014 8:00 a.m. - 12:00 p.m.
PDT
- miR-221: a Potential Therapeutic Target for Hepatocellular
Carcinoma
- A miR-221 Multigene Pharmacodynamics Signature for Assessing
miR-221 Inhibition
- Oral Presentation by Sanofi on miR-21 – April 8, 2014 3:35 p.m.
PDT
- Targeting microRNA-21 in Hepatocellular Carcinoma
- Poster Session on microRNA Expression - April 9, 2014 8:00 a.m. -
12:00 p.m. PDT
- Serum microRNAs Reflect microRNA Expression in Tumor Tissues
as Well as Systemic Response to Disease in HRAS-driven Mouse Models
of HCC
"Utilizing both genetic and pharmacological approaches, the data
to be presented at AACR provide further evidence that miR-21 and
miR-221 are validated preclinical targets for the treatment of
hepatocellular carcinoma," said Neil W.
Gibson, Ph.D., Chief Scientific Officer of Regulus. "In
addition, we've made progress to develop gene signatures that
enable demonstration of target inhibition in tumor
tissues. We believe these gene signatures and the
overall approach enable Regulus to demonstrate proof of mechanism
in preclinical studies which may be translated into useful
biomarker signatures in potential future clinical trials."
Update on Regulus' Liver Cancer Intellectual Property
Estate
As part of Regulus' rich intellectual property estate, Regulus
controls patent rights related to the modulation of multiple
different microRNAs for the treatment of liver cancer. Regulus has
already received patents in the United
States for targeting multiple different microRNAs, including
miR-21 and miR-221/222, for the treatment of liver cancer. Also
included in the Regulus portfolio are fundamental patent rights
claiming methods of treating liver cancer with mimics of
microRNA-34a, one of the most well-validated tumor suppressor
microRNAs.
Today, Regulus is pleased to announce receipt of a Decision to
Grant a Patent from the Japan Patent Office for the use of
anti-miRs targeting multiple different microRNAs, including miR-21
and miR-222, for the treatment of liver cancer.
"We are pleased to see our liver cancer patent estate further
bolstered with new claims in a major market such as Japan. We
believe our claims broadly cover the use of pharmaceutically
relevant compounds targeting any of these multiple different
microRNAs for the treatment of liver cancer," said David L. Szekeres, Chief Business Officer and
General Counsel of Regulus. "As evidenced by these new
claims, we continue to extract maximum value from our broad
intellectual property estate, solidifying Regulus' position as the
recognized leader in the field of microRNA therapeutics."
About Regulus' Intellectual Property Estate
Regulus believes that it has a leading intellectual property
position and substantial know-how relating to the development and
commercialization of microRNA therapeutics, composed of
approximately 200 patents and patent applications that the company
owns or has in-licensed from academic institutions and third
parties including its founding companies, Alnylam Pharmaceuticals,
Inc. and Isis Pharmaceuticals, Inc., related to microRNA and
microRNA drug products. Regulus also has access to
approximately 850 patents and patent applications exclusively
related to RNA technologies, including patents and patent
applications relating to chemical modification of oligonucleotides
that are useful for the development of microRNA therapeutics.
About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a
biopharmaceutical company leading the discovery and development of
innovative medicines targeting microRNAs. Regulus is uniquely
positioned to leverage a mature therapeutic platform that harnesses
the oligonucleotide drug discovery and development expertise of
Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., which
founded the company. Regulus has a well-balanced
microRNA therapeutic pipeline entering clinical development, an
emerging microRNA biomarkers platform to support its therapeutic
programs, and a rich intellectual property estate to retain its
leadership in the microRNA field. Regulus intends to focus
its proprietary efforts on developing microRNA therapeutics for
oncology indications and orphan diseases and is currently advancing
several programs toward clinical development in oncology, fibrosis
and metabolic diseases. Specifically, Regulus is developing
RG-012, an anti-miR targeting microRNA-21 for the treatment of
Alport Syndrome, a life-threatening kidney disease driven by
genetic mutations with no approved therapy, and RG-101, a
GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment
of chronic hepatitis C virus infection. Regulus' commitment
to innovation and its leadership in the microRNA field have enabled
the formation of strategic alliances with AstraZeneca,
GlaxoSmithKline and Sanofi. In addition, the Company has
established Regulus microMarkers™, a research and development
division focused on identifying microRNAs as biomarkers of human
disease, which is designed to support its therapeutic pipeline,
collaborators and strategic partners.
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 Regulus' expectations
regarding future therapeutic and commercial potential of Regulus'
business plans, technologies and intellectual property related to
microRNA therapeutics 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, 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' programs are described in additional detail in
Regulus' SEC filings. 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.
SOURCE Regulus Therapeutics Inc.