New Development Programs to Include Response Prediction to Ovarian Cancer
Treatment, Predicting Risk of Gastric Cancer Recurrence, and
Differentiation of Small Cell From Non-Small Cell Lung Cancer In Addition, the Company has Identified Unique microRNA Biomarkers in the Serum of Colon Cancer Patients, Which may Serve as the Basis for a Future
Test for Colon Cancer New Tests Expected to be Developed and Marketed Through the Company's Clinical Laboratory Improvement Act (CLIA) Certified Laboratory, for Which
a Binding Acquisition Term Sheet has Recently Been Signed
REHOVOT, Israel and JERSEY CITY, New Jersey, June 18 /PRNewswire-FirstCall/ -- Rosetta Genomics Ltd. (Nasdaq: ROSG), a leader in the development of microRNA-based diagnostics and therapeutics, announced today the advancement of three new diagnostic tests into its development pipeline. The Company expects to develop and market the new tests through its own CLIA-certified laboratory, for which the Company recently signed a binding acquisition term sheet.
"We aim to be the leading high-complexity molecular diagnostics company, and we believe we have fine-tuned our product engine. This engine is now capable of producing a stream of products that answer unmet medical needs," said Amir Avniel, CEO and President of Rosetta Genomics. "We believe that by the end of 2009, we will have established a prominent position in the oncology and women's health fields."
Leveraging unique microRNA biomarkers identified using Rosetta Genomics' proprietary microRNA extraction and quantification methods, the new programs will focus on the following indications, which are expected to be clinically available during 2009-2010:
1) Predicting response to treatment of ovarian cancer patients
- Platinum-based cytotoxic chemotherapy in conjunction with debulking surgery is currently the gold standard of treatment for patients with ovarian cancer. However, approximately 20-50% of patients do not respond to platinum-based chemotherapy and will require additional second line treatment. Furthermore, research suggests that administering platinum-based treatment to patients who subsequently do not respond to it may actually hinder their response to the second line treatment as well. Rosetta Genomics has identified unique microRNA biomarkers that may assist in identifying ovarian cancer patients expected to benefit from platinum-based chemotherapy.
2) Predicting risk of gastric cancer recurrence - Recurrence after curative resection for gastric cancer is high and is estimated to occur in 50-80% of patients. This test will use microRNA molecular classification of gastric cancer samples to predict the risk of recurrence for non-metastatic patients after resection of the primary tumor.
3) Differentiating small from non-small cell lung cancer - An estimated 220,000(1) patients are diagnosed with lung cancer each year in the U.S. alone. Before a patient begins lung cancer treatment, an experienced lung cancer pathologist must review the pathologic material. This is critical because small cell lung cancer, which is generally not treated surgically, can be confused on microscopic examination with non-small cell carcinoma(2). Rosetta Genomics has identified unique microRNA biomarkers that may be used to differentiate small from non-small cell lung cancers.
In addition, utilizing its proprietary extraction and quantification microRNA technologies, the Company has recently identified microRNA biomarkers in the serum of colon cancer patients which may serve as the basis for a future blood-based test for colon cancer.
"Molecular diagnostic companies like Rosetta Genomics are well positioned to enjoy accelerated growth, unprecedented in the traditional diagnostics market," noted Ronen Tamir, Executive Vice President of Marketing and Communication of Rosetta Genomics. "Our rich product pipeline, combined with the upcoming acquisition of a commercial CLIA-certified laboratory, will position us to participate in such a growth trend in the molecular diagnostics industry."
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 strategy for many diseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNAs. 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 and therapeutic tools, focusing primarily on cancer and various women's health indications.
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 expected timing of submission for approval and launch of diagnostic tests using its microRNA technology, 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 is unproven and may never lead to marketable products or services, including development of tests for predicting response to ovarian cancer treatment, risk of gastric cancer recurrence, differentiation of small from non-small cell lung cancer and identification of unique microRNA biomarkers for colon cancer,; 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; 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 acquire and successfully operate a CLIA-certified laboratory; Rosetta's ability to successfully develop its candidate tools, products and services, all of which are in early stages of development; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; Rosetta's 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, 2006 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.
(1) American Cancer Society website, 2008
(2) Travis WD, Colby TV, Corrin B, et al.: Histological typing of lung
and pleural tumours. 3rd ed. Berlin: Springer-Verlag, 1999.
|SOURCE Rosetta Genomics Ltd|
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