Ability to forecast outcomes for malignant pleural mesothelioma (MPM) may enable clinicians to provide aggressive therapy to the most appropriate patients
REHOVOT, Israel & PHILADELPHIA--(BUSINESS WIRE)--Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published online on February 16th, 2010, and are set to be published in the March 1st issue of the American Association for Cancer Research’s journal, Cancer Research. The study, “Hsa-Mir-29c* is Linked to the Prognosis of Malignant Pleural Mesothelioma,” demonstrates the potential of a single microRNA to act as an independent prognostic factor for time to progression as well as survival after surgery. The abstract of the study may be viewed online at: http://cancerres.aacrjournals.org/cgi/content/abstract/0008-5472.CAN-09-3993v1
“In addition to the significant clinical importance of being able to forecast outcomes of MPM, this study demonstrates the tremendous potential microRNAs hold as biomarkers”
In the study, 142 MPM tumors were analyzed for microRNA expression levels using Rosetta Genomics’ proprietary microRNA-based array and qRT-PCR technologies. The results clearly demonstrate that higher levels of miR-29c* in MPM predict a more favorable prognosis. Not only was the microRNA able to separate MPM patients by time to progression after surgery, but it also stratified these patients by their survival.
When examining Time to Progression (TTP) of MPM, the expression level of miR-29c* enabled the identification of two groups with significantly different median TTP: 4 months versus 14 months in the study’s training set, and 5.5 months versus 12.8 months in the study’s test set.
When examining survival rates for MPM, the expression level of miR-29c* enabled the identification of two groups as well: median survival of 8 months versus 32 months in the study’s training set, and median survival of 9.1 months versus 21.6 months in the study’s test set. This new diagnostic capability may help physicians apply more aggressive therapeutic modalities to the poor prognosis group.
Furthermore, the study found that over-expression of miR-29c* in mesothelioma cell lines resulted in significantly decreased proliferation, migration, invasion and colony formation.
“This is an exciting discovery which may have significant clinical impact on the treatment of MPM,” said Harvey Pass, M.D., Professor and Chief, Division of Thoracic Surgery and Thoracic Oncology at NYU Langone Medical Center, and the lead investigator of this study. “While MPM is an aggressive cancer, our study showed that we can use a single microRNA to identify subgroups of patients who differ significantly in their time to progression and survival. When applied to a clinical setting, these findings may enable clinicians to apply multimodality therapy to the most appropriate patients. Furthermore, I think it is remarkable that a single biomarker can provide such insights into disease prognosis.”
“In addition to the significant clinical importance of being able to forecast outcomes of MPM, this study demonstrates the tremendous potential microRNAs hold as biomarkers,” noted Kenneth A. Berlin, President and CEO of Rosetta Genomics. “NYU Langone Medical Center chose Rosetta Genomics’ platform technology for this study as it was the most technologically advanced, offering an extremely high sensitivity and specificity suitable for studying microRNAs in the clinical setting. The results of this study further validate the strength of our microRNA platform technologies and our ability to leverage that strength to help advance the standard of care.”
About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. MicroRNAs’ unique advantage as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly in samples preserved by this method. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.
About miRview™ Products
miRview™ are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview™ squamous accurately identifies the squamous subtype of NSCLC, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview™ meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview™ tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, over 100,000 patients a year may benefit from the miRview™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ meso, with similar numbers of patients outside the U.S. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.com.
About Rosetta Genomics
Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company’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 Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The company’s first three microRNA-based tests, miRview™ squamous, miRview™ mets and miRview™ meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. To learn more, please visit www.rosettagenomics.com .
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to the potential applications of a microRNA-based test to forecast the outcome of MPM, the role of microRNAs in human physiology and disease, and the potential of microRNAs in the diagnosis and treatment of disease, 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 risks related to: Rosetta’s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta’s ability to obtain, maintain and protect its intellectual property; Rosetta’s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta’s need and ability to obtain additional funding to support its business activities; Rosetta’s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta’s ability to successfully develop its products and services; Rosetta’s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta’s technology; competition from others using technology similar to Rosetta’s and others developing products for similar uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating history; as well as 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, 2008 as filed with the Securities and Exchange Commission. 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.
