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Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer
Date:2/12/2009

PHILADELPHIA, and REHOVOT Israel, February 12 /PRNewswire-FirstCall/ -- Rosetta Genomics Ltd. (Nasdaq: ROSG) reported today the first ever in-vivo efficacy data for a systemic microRNA-based cancer therapeutic. The animal-model study demonstrated a marked suppression of a microRNA that was found to be over expressed in human hepato-cellular carcinoma (HCC), and a significant two-fold reduction of tumor mass. These data are being presented at the Keystone Symposium, Therapeutic Modulation of RNA Using Oligonucleotides, at Lake Louise, Alberta Canada, on February 12th.

Liver cancer is the third cause of cancer death globally, affecting over 19,000 patients annually in the US alone. Prognosis is extremely grim, with nine out of ten patients dying within 5 years. Sorafenib (Nexavar(R)), the only oral anti-cancer drug currently approved for systemic therapy for HCC, extends survival by approximately 3 months.[1]

Rosetta's scientists first identified miR-191, a microRNA that is abnormally over-expressed in human liver cancer cells, and which when inhibited effectively reduces cell proliferation and promotes cell-death of these liver tumor cells. The scientists then used an in-vivo model called Orthotopic Xenograft, in which an artificial tumor fragment derived from a human liver cancer cell line is transplanted into livers of mice, in order to evaluate the efficacy of systemic microRNA-based treatment in these mice. Chemically modified antisense oligos (ASOs) were delivered systemically, targeting the over-expressed microRNA. Using this animal model, the scientists have shown that the targeted microRNA was markedly decreased in mice livers and was practically undetectable within the tumor itself, and that the tumor mass was significantly reduced two-fold, within 40 days of treatment.

Interestingly, the researchers showed that Dioxin, one of the most toxic substance ever identified and a known liver cancer carcinogen,[2] markedly increases the expression of the targeted microRNA.

"We view this study as a landmark event in the development of microRNA based cancer therapeutics" said Amir Avniel, President and CEO of Rosetta Genomics. "While Rosetta's clear focus is on developing diagnostics, this collaborative project with Regulus is an example of how we intend to leverage the tremendous potential that microRNA holds in therapeutics and other domains. Every one of our diagnostic biomarkers is also a potential drug target, and we intend to form strategic alliances with suitable biopharma partners to leverage and commercialize these opportunities."

The data presented at the conference is now available for downloading on the company's website at: http://www.rosettagenomics.com/HCC-study

    The study is supported by a grant from the BIRD foundation.

    [1] Llovet et al., Sorafenib improves survival in advanced Hepatocellular
        Carcinoma (HCC): Results of a Phase III randomized placebo-controlled
        Trial (SHARP trial), Journal of Clinical Oncology, 2007 ASCO Annual
        Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement),
        2007: LBA1

    [2] Health Risks from Dioxin and Related Compounds, National
        Research Council, National Academies Press, 2006

Nexavar(R) (sorafenib) is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) 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 IP 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(TM) squamous, miRview(TM) mets, and miRview(TM) meso, are commercially available through its Philadelphia-based CLIA-certified lab. Rosetta Genomics is the 2008 winner of Wall Street Journal's Technology Innovation Awards in the medical/biotech category.

About MicroRNA

MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic and therapeutic strategy for many diseases.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, and the success and timing of the hepatocellular carcinoma therapeutic program, 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 and develop novel diagnostics and therapeutic tools, which is unproven and may never lead to commercially accepted products or services; Rosetta's ability to fund and the results of further pre-clinical and clinical trials; Rosetta's ability to obtain, maintain and protect the intellectual property utilized by Rosetta's products; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties and its ability to operate without infringing the proprietary rights of others; Rosetta's 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 and commercialize its candidate tools, 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, 2007 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.

    Contact:

    Media& Investors,
    Ron Kamienchick,
    T: +1-646-509-1893,
    E: investors@rosettagenomics.com .



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SOURCE Rosetta Genomics Ltd
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