Project to advance studies on the role and
molecular mechanism of microRNAs in ibrutinib resistance in Mantle
Cell Lymphoma for development of microRNA-based predictive
biomarkers
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based molecular and other diagnostics,
announces the selection of the first project grant under its
strategic alliance with Moffitt Cancer Center. The funded project
is titled, “miRNAs as Determinants and Predictors of Ibrutinib
Resistance in Mantle Cell Lymphoma (MCL).” The project will be led
by Jianguo Tao, M.D., Ph.D., a renowned hematopathologist and
physician-scientist at the Molecular and Chemical Biology Program
at Moffitt, and Bijal Shah, M.D., an oncologist in the
Experimental Therapeutic Program at Moffitt.
MCL is an aggressive B-cell lymphoma. Ibrutinib, a blockbuster
pharmaceutical marketed by Pharmacyclics under the brand name of
IMBRUVICA®, is a novel Bruton's tyrosine kinase (BTK) inhibitor
that received U.S. Food and Drug Administration approval for the
treatment of MCL in 2014, with high response rates reported in
patients with MCL. However, many MCL patients who initially
show a partial or complete response to ibrutinib, eventually
develop ibrutinib-acquired drug resistance accompanied by fulminant
progression and accelerated mortality.
Studies conducted by Drs. Tao and Shah have suggested that
microRNAs play a role in the development of resistance to
ibrutinib. The goal of this funded project is to further explore
the role and underlying molecular mechanism of microRNAs in
ibrutinib resistance in MCL, for development of microRNA-based
predictive biomarkers for ibrutinib therapy, as well as for a
rational design to overcome drug resistance.
Commenting on the project, Dr. Tao noted, “We have previously
identified a decreased expression of a set of tumor suppressor
microRNAs that drive MCL drug resistance and aggressive progression
through negative regulation of PI3K and other survival pathways.
Consequently, we believe these microRNAs represent ideal targets
and biomarkers due to their role not only in supporting MCL cell
growth, but also facilitating drug resistance.”
“We are very excited about the potential of this project as the
earlier work conducted by Drs. Tao and Shah puts us in a unique
position to further explore the role and underlying molecular
mechanism of microRNAs in ibrutinib resistance in MCL,” stated
Kenneth A. Berlin, President and Chief Executive Officer of Rosetta
Genomics. “We believe the new knowledge to be generated by this
project would speed up the development of microRNA-based predictive
biomarkers for ibrutinib therapy for the benefit of MCL and
potentially other patients.”
“We are excited to have selected this first project under our
alliance with Rosetta Genomics. Moffitt is committed to bringing
innovative oncology diagnostics to patients in order to optimize
clinical outcomes and this project for the development of
predictive biomarkers for ibrutinib therapy in the treatment of MCL
patients exemplifies these goals as the development of drug
resistance in these patients is life-threatening,” said Anthony
Magliocco, M.D., chair of the Anatomical Pathology Program and
executive director of the Morsani Molecular Diagnostics Laboratory
at Moffitt.
About the Rosetta Genomics/Moffitt Cancer Center Strategic
Alliance
The three-year alliance brings together the resources and
talents of Moffitt, a National Cancer Institute-designated
Comprehensive Cancer Center, with those of Rosetta Genomics, an
industry-leading developer of microRNA-based diagnostics, to
stimulate new projects and collaborations for the development of
diagnostics in areas of unmet medical need. Rosetta is providing
funding for Moffitt investigator-initiated projects that align with
Rosetta’s strategic priorities and has the rights to license
intellectual property that results from such projects on
pre-negotiated terms.
About Moffitt Cancer Center
Located in Tampa, Florida, Moffitt is one of only 41 National
Cancer Institute-designated Comprehensive Cancer Centers, a
distinction that recognizes Moffitt’s excellence in research,
its contributions to clinical trials, prevention and cancer
control. Moffitt is the top-ranked cancer hospital in the Southeast
and has been listed in U.S. News & World Report’s “Best
Hospitals” for cancer care since 1999. With more than 4,500
employees, Moffitt has an economic impact in the state of nearly
$1.6 billion. For more information, please visit MOFFITT.org.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta’s assays are designed to provide objective
diagnostic data. In the U.S. alone, Rosetta Genomics estimates that
200,000 patients a year may benefit from the Rosetta Cancer Origin
Test™, 62,000 from the Rosetta Kidney Cancer Test™ and 222,000
patients from the Rosetta Lung Cancer Test™. The Company’s assays
are offered directly by Rosetta Genomics in the U.S., and through
distributors around the world. In addition to its proprietary
products, the Company markets the Rosetta Genomics PGxOne™ and EGFR
and KRAS tests for Admera Health. With the recent acquisition of
PersonalizeDx, the company now offers a broader menu of molecular
and other assays for bladder, lung, prostate and breast cancer
patients. For more information, please visit
www.rosettagenomics.com. Parties interested in ordering any of
these tests can contact Rosetta Genomics at (215) 382-9000 ext.
309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s
integrative research platform combining bioinformatics and
state-of-the-art laboratory processes has led to the discovery of
hundreds of biologically validated novel human microRNAs. Building
on its strong patent position and proprietary platform
technologies, Rosetta is working on the application of these
technologies in the development and commercialization of a full
range of microRNA-based diagnostic tools. PersonalizeDx’s core
FISH, IHC and PCR-based testing capabilities and partnerships in
oncology and urology provide additional content and platforms that
complement the Rosetta offerings. Rosetta’s and PersonalizeDx’s
cancer testing services are commercially available through the
Philadelphia, PA- and Lake Forest, CA-based CAP-accredited,
CLIA-certified labs, respectively.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without
limitation, statements relating to the cooperation
between Rosetta Genomics and Moffitt Cancer Center, the ability of
microRNA’s to act as biomarkers for drug resistance, that any
knowledge gained through the research, if gained, speeding up the
development of microRNA-based predictive biomarkers for ibrutinib
therapy, and that the research benefiting MCL and potentially other
patients, constitute forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Actual results may differ materially
from those indicated by these forward-looking statements as a
result of various important factors, including those risks more
fully discussed in the "Risk Factors" section of Rosetta’s Annual
Report on Form 20-F for the year ended December 31, 2014 as
filed with the SEC. In addition, any forward-looking statements
represent Rosetta’s views only as of the date of this release and
should not be relied upon as representing its views as of any
subsequent date. Rosetta does not assume any obligation to update
any forward-looking statements unless required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20150526005611/en/
Company:Rosetta GenomicsKen Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestors:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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