AUSTIN, TX (May 13, 2013)– Mirna Therapeutics, Inc., a biotechnology company pioneering microRNA (miRNA) replacement therapies for cancer,
announced today that it has initiated a Phase 1 clinical study of MRX34, the first miRNA to advance into a human clinical trial for cancer. The Phase 1 trial is being conducted in patients with unresectable primary liver cancer or metastatic cancer with liver involvement.

“The initiation of this clinical trial is a landmark event for cancer drug development,” said Paul Lammers, M.D., President and Chief Executive Officer of Mirna Therapeutics. “Scientists at Mirna were among the first to elucidate the promise of tumor suppressor miRNAs as new therapeutic candidates. The preclinical profile of MRX34 across a range of tumors strongly suggests that miRNA-based therapeutics may represent a potent, new class of anticancer drugs working through a mechanism that affects multiple oncogenic pathways simultaneously.”

“Results from this initial clinical trial will be used to evaluate the safety of MRX34, and help us evaluate the potential of this compound for further clinical study,” said Andrew Brenner, M.D., Ph.D., medical oncologist and assistant professor in the School of Medicine at The University of Texas Health Science Center at San Antonio, and principal investigator on the study being conducted at the Cancer Therapy & Research Center at the Health Science Center. “ We are excited to be the first to bring this new and innovative therapeutic approach to our patients. We look forward to reviewing the clinical data and to furthering the study of miRNA-based cancertherapeutics.”

The Phase 1 MRX34 study will follow a standard oncology study design, consisting of an initial dose-escalation phase followed by an enrichment phase, and is expected to enroll up to 48 patients in total. MRX34 is a miRNA “mimic” of tumor suppressor miR-34 delivered using a liposomal delivery formulation in-licensed from Marina Biotech. Mirna filed its first Investigational New Drug Application with the U.S. Food and Drug Administration for MRX3 4 earlier this year. Additional information on the study and enrollment can be found at clinicaltrials.gov (http://clinicaltrials.gov/ct2/show/NCT01829971).

This project is funded in part by a Cancer Prevention and Research Institute of Texas (CPRIT) Commercialization grant.

About miRNAs

miRNAs are approximately 20-25 nucleotides long and affect gene expression by interacting with messenger RNAs. Unlike short interfering RNAs (siRNAs), miRNAs are encoded in the human genome and are used as natural regulators of global gene expression. More than 1,500 miRNAs are encoded in the human genome and are thought to control expression of approximately 30% of all genes. Since each miRNA appears to regulate the expression of tens to hundreds of different genes, miRNAs can function as “master-switches,” efficiently regulating and coordinating multiple cellular pathways and processes. Misregulation of miRNAs appears to play a fundamental role in the occurrence, growth and dissemination of many cancers, and replacement of down regulated miRNAs in tumor cells results in a positive therapeutic response.

About Mirna Therapeutics

Mirna Therapeutics, Inc. (Mirna) is a biotechnology company focused on the development and commercialization of miRNA therapeutics. The Company has a foundational intellectual property portfolio on the therapeutic use of miRNAs developed by its own scientists as well as in-licensed from other institutions. Mirna’s IP portfolio contains more than 300 miRNAs with applications in oncology and other diseases. Oncology-directed miRNAs include those that are key tumor suppressors in cancer, such as miR-34 and let-7, which have been shown to block tumor growth in a number of different preclinical animal studies. The Company, founded in 2007 and located in Austin, Texas, has received significant funding from Sofinnova Ventures, New Enterprise Associates, Pfizer Venture Investments and other private investors, as well as the State of Texas, both through the State’s Emerging Technology Fund and from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, visit www.mirnarx.com.

Contact:
Mirna Therapeutics, Inc.
Paul Lammers, M.D., M.Sc.
President and CEO
512.901.0909
plammers@mirnarx.com

LA JOLLA, Calif., May 14, 2013 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today provided an update on its microRNA therapeutic pipeline under the company’s ‘Road to the Clinic’ strategy and reported financial results for the quarter ended March 31, 2013.

Regulus Continues to Execute on ‘Road to the Clinic’ Strategy:
Nominated RG-101 as First microRNA Candidate for Clinical Development

• Regulus announced today that it has nominated its first microRNA candidate for clinical development, RG-101, a GalNAc-conjugated microRNA antagonist or anti-miR, which targets microRNA-122 (miR-122) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Regulus is performing additional pre-clinical studies and finalizing development plans for RG-101 in HCV and expects to submit an application with regulatory authorities in early 2014.
• Regulus plans to develop RG-101 independently of its strategic alliance with GlaxoSmithKline (GSK).  The broad strategic alliance between Regulus and GSK remains intact and GSK retains its interest in the miR-122 program in HCV, as miR-122 will remain a Collaboration Target under the alliance.   As such, the companies are in the process of amending the Product Development and Commercialization Agreement to clarify that RG-101 is fully owned by Regulus.

“The nomination of RG-101 as our first microRNA candidate for clinical development marks a tremendous milestone for Regulus and represents significant achievement of our initial goals under our ‘Road to the Clinic’ strategy,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “We continue to focus our efforts on preparing for a successful transition to a clinical-stage company and remain on track to nominate our second microRNA candidate for clinical development by the end of the year.  Our recent progress is encouraging and we look forward to realizing the potential that our microRNA technology may have in transforming the field of drug discovery.”

Neil W. Gibson, Ph.D., Chief Scientific Officer, added, “We believe that RG-101 is a novel, pan-genotypic agent that may play an important role in future HCV therapy. We are very encouraged by the pre-clinical data seen to date, which includes activity against some of the known mutations that lead to resistance to the current HCV therapies and a favorable potency and PK profile which supports a once-a-month dosing paradigm.  We believe that RG-101 may be useful in difficult-to-treat HCV patients in combination with existing and emerging therapies and we look forward to exploring its clinical utility.”

Garry E. Menzel, Ph.D., Chief Operating Officer and Executive Vice President of Finance, said, “As we prepare for clinical activity with RG-101, Regulus continues to maintain a strong financial position with over $90 million in cash at quarter-end. We remain on track to achieve our stated goals of finishing 2013 with at least $60 million in cash, while maintaining a burn rate of approximately $30 million to $35 million.”

Recent Highlight

• Selected New Opportunity in Oncology.  Regulus also announced today that it has selected microRNA-221 (miR-221) as an attractive target for potential clinical evaluation in patients with hepatocellular carcinoma (HCC).  Regulus is currently conducting target validation activities and expects to report further progress on this opportunity in the second half of 2013.

First Quarter 2013 Financial Results & Highlights

Regulus reported a net loss of $7.2 million for the quarter ended March 31, 2013, compared to a net loss of $2.2 million for the quarter ended March 31, 2012.  The quarter ended March 31, 2013, included non-cash charges of $1.8 million from the change in value of the amended and restated convertible promissory note originally issued to GlaxoSmithKline in 2010, which was attributable to increases in value of the underlying common stock of the Company since December 31, 2012.  Basic and diluted net loss per share was $0.20 for the quarter ended March 31, 2013, compared to net loss per share of $13.06 for the quarter ended March 31, 2012. The comparison of net loss per share for the periods presented is impacted by the initial public offering and concurrent common stock issuances in October 2012.

Regulus recognized revenue of $3.2 million for the quarter ended March 31, 2013, compared to $3.3 million for the quarter ended March 31, 2012.  Revenue during these periods consisted primarily of amortization of up-front payments received from our strategic alliances and collaborations, which is recognized over the estimated period of performance.

Research and development expenses were $6.9 million for the quarter ended March 31, 2013, compared to $4.6 million for the quarter ended March 31, 2012.  The increase is attributable to an expansion of our research and development team, expertise and capabilities, in addition to increasing pre-clinical study activities in the first quarter of 2013, compared to the same period in 2012.

General and administrative expenses were $1.9 million for the quarter ended March 31, 2013, compared to $0.9 million for the quarter ended March 31, 2012.  The increase is attributable to costs associated with increases related to additional personnel required to support the growth of the business, in addition to an increase in overall operating costs associated with being an SEC registrant in the first quarter of 2013, compared to the same period in 2012.

As of March 31, 2013, Regulus had $90.7 million in cash, cash equivalents and short-term investments, debt with a principal balance of $5.4 million and approximately 36 million shares of common stock outstanding.  The Company expects its current cash position to be sufficient to fund operations into 2016 and to finish 2013 with at least $60.0 million in cash, cash equivalents and short-term investments.

 

Conference Call & Webcast Information

Regulus will host a conference call and webcast at 5:00 p.m. Eastern Daylight Time today for an update on the ‘Road to the Clinic’ Strategy and to discuss its first quarter 2013 financial results and recent highlights. A live webcast of the call will be available online at www.regulusrx.com. A replay will also be available approximately one hour after completion of the call. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 59485223. The webcast and replay will be archived on the company’s website following the call.

 

About the ‘Road to the Clinic’ Strategy in 2013

Launched in February 2013, the ‘Road to the Clinic’ Strategy outlines certain corporate goals that seek to advance our microRNA therapeutic pipeline toward the clinic this year. Specifically, Regulus set the goal of nominating two microRNA candidates for clinical development in 2013.  We announced the first candidate today as RG-101 for the treatment of HCV.  The company also expects to file its first applications with regulatory authorities in 2014, with the first being for RG-101 in early 2014.  In order to achieve these stated goals and advance our programs toward clinical development, Regulus expects to maintain its strong financial position and end 2013 with at least $60 million in cash, cash equivalents and short-term investments.

About Regulus

Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus is leveraging a mature therapeutic platform based on technology that has been developed over 20 years. Regulus works with a broad network of academic collaborators and leverages the oligonucleotide drug discovery and development expertise of its founding companies, Alnylam Pharmaceuticals and Isis Pharmaceuticals. Regulus has nominated RG-101 for the treatment of HCV as a candidate for clinical development and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. Regulus has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

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 financial estimates, the projected sufficiency of Regulus’ capital position for future periods, the expected ability of Regulus to undertake certain activities and accomplish certain goals, the projected timeline of clinical development activities, and 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’ financial position and 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.

NEW YORK, April 8, 2013 /PRNewswire/ – Exosome Diagnostics, a leading developer of biofluid-based molecular diagnostics for use in personalized medicine, today announced that the company is presenting a late-breaking abstract at the AACR Annual Meeting 2013, in Washington D.C.  The abstract is titled “Exosome profiling of mRNAs and miRNAs in serum samples from GBM (glioblastoma multiforme) patients.” It will be presented during Poster Session 47 from 1 to 5 p.m. EDT on April 8 by Johan Skog, Ph.D., the newly appointed chief scientific officer of Exosome Diagnostics.

In this study, Exosome Diagnostics used its proprietary RNA-extraction technology to measure a broad spectrum of full-length mRNA and microRNA from low volumes (2 mL) of frozen, archival serum from brain cancer patients enrolled in a therapeutic clinical trial.  Prior to the introduction of Exosome Diagnostics’ technology, similar biomarker analysis would have required performing invasive brain tissue biopsies.

This clinical study represents the third biofluid in which Exosome Diagnostics has demonstrated the ability to harvest disease-specific RNA biomarkers.  Data have been presented in clinical studies from different disease groups from urine, blood, and cerebrospinal fluid exosome preparations.

“Extraction of high-quality RNA, particularly intact messenger RNA, from blood, urine or CSF samples is an important advance for discovering and measuring both known and novel biomarkers for patient selection and drug response,” said Johan Skog, Ph.D.  “This study demonstrates that frozen and archived biofluid samples can be interrogated for gene expression along with fresh samples in patient populations of interest to clinical investigators and drug developers.”

James McCullough, chief executive officer of Exosome said, “Rapid, reproducible extraction of high quality RNA with appropriate internal quality control from frozen blood samples satisfies an important request from our pharmaceutical partners to unlock the potential of their vast clinical trial bio-banks.  We are now firming plans to launch an Exosome Diagnostics life sciences kit product line in early 2014 to enable drug developers and researchers to pursue biomarker discovery in cancer, CNS and other diseases.”

Exosomes are microscopic packages shed by all cells into biofluids such as blood, urine and cerebrospinal fluid.  Exosomes protect an abundance of active genetic material (ribonucleic acid or “RNA”) that, when properly harvested, can produce accurate molecular diagnostic measurements using standard PCR and sequencing instruments.  In addition to its planned life science product line, Exosome Diagnostics has been conducing multi-center clinical validation studies in partnership with the Prostate Cancer Foundation for the first-ever regulated exosome in vitro diagnostic, which targets early stage prostate cancer from a random patient urine sample.

About Exosome Diagnostics
Exosome Diagnostics is a leading developer of biofluid-based molecular diagnostic tests for use in personalized medicine. Exosomes are shed into all biofluids, including blood, urine and CSF, providing a stable source for intact, cell-specific nucleic acids. The Company’s proprietary exosome technology makes use of the presence and natural stability of RNA in exosomes to detect and measure levels of genes responsible for cancer and other diseases. The Company is developing in vitro diagnostic tests for use in companion diagnostic applications and real-time monitoring of disease. For more information, please visit www.exosomedx.com.

SOURCE Exosome Diagnostics

HOERSHOLM, Denmark and SAN DIEGO, March 27, 2013 /PRNewswire/ — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the publication of study results online in the New England Journal of Medicine (NEJM). The publication highlights the potential benefits of miravirsen, a host-targeted, pan-HCV genotype anti-viral agent and the first microRNA-targeted drug to enter clinical trials for the treatment of Hepatitis C virus (HCV). In the study, miravirsen, given as a four-week monotherapy treatment, provided robust dose-dependent antiviral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL). The effect was sustained well beyond the end of therapy.

Clinical data from the Phase 2a study demonstrated the following:

• Miravirsen was safe, well tolerated and provided prolonged antiviral activity well after the last dose of miravirsen monotherapy (x5 weekly injections)
• There were no signs of viral resistance
• Adverse events were infrequent, mild and did not lead to study drug discontinuation
• There were no dose limiting toxicities or discontinuations due to adverse events
• Miravirsen was associated with dose-dependent reductions in HCV RNA that were sustained well beyond the end of the four-week dosing period
• Four out of nine patients treated at the highest dose (7 mg/kg) with miravirsen became HCV RNA undetectable with just five weekly doses of miravirsen monotherapy

“We are excited because the data show that miravirsen offers long-lasting suppression of HCV RNA, a high barrier to viral resistance, a favorable tolerability and dosing profile, a low propensity for drug interactions and a very long duration of action. All of these properties suggest that miravirsen’s unique mechanism-of-action may offer a potential cure for Hepatitis C patients, either in combination with other antiviral agents or as a monotherapy,” said Harry Janssen, M.D., Head of the Liver Clinic at Toronto Western and Toronto General Hospital and lead author of the NEJM publication. “Due to its ability to target the host factor miR-122, miravirsen has the potential to change the way Hepatitis C is treated. This study is also the first to prove that blocking microRNA can be effective in treating Hepatitis C in humans without limiting side effects. This trial is a landmark study for new therapeutic modalities in many other diseases where microRNA’s play a role, such as in cardiovascular disease, cancer and metabolic disorders.”

Developed using Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform, miravirsen is an inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the replication of the virus is effectively inhibited and the level of Hepatitis C virus is profoundly reduced.

“This is a seminal moment for the microRNA community as miravirsen is the first microRNA targeted drug to show efficacy in clinical trials, and we are honoured that such a prestigious journal as the New England Journal of Medicine has published this work,” said Henrik Stage, Chief Executive Officer at Santaris Pharma A/S. “It’s amazing to think that the journey from bench to bedside has occurred over such a short span of time. Recall that human microRNAs were only discovered in 2001, and miR-122′s role in the HCV lifecycle determined in 2005. Based on the published results, microRNA targeted therapy has shown its potential to become a new important class of drugs, and the LNA platform has demonstrated its role as the chemistry of choice for RNA targeted therapies.”

The randomized, double-blind, placebo-controlled, ascending multiple-dose Phase 2a study assessed the safety and tolerability of miravirsen in treatment-naive patients with chronic HCV genotype 1 infection. Patients were enrolled sequentially to one of three cohorts (9 active: 3 placebo per cohort) at doses of 3, 5 and 7 mg/kg. Miravirsen was given as a total of 5 weekly subcutaneous injections over 29 days.

“These study results are the culmination of over 6 years of microRNA research at Santaris Pharma A/S,” said Michael R. Hodges, MD, Vice President and Chief Medical Officer at Santaris Pharma A/S. “The results of this study highlight miravirsen’s exceptional high barrier to resistance, long duration of action and good tolerability. Miravirsen would be especially suitable for treatment of hard-to-treat patients, for example those patients who have already failed treatment with pegylated-interferon and ribavirin combination or protease inhibitor triple therapy.” Dr. Hodges continued, “Longer treatment durations of miravirsen are currently being tested in clinical trials in subjects who have failed initial therapy for HCV infection.”

About Hepatitis C
Hepatitis C infection is a viral disease caused by the Hepatitis C virus that leads to inflammation of the liver. The World Health Organization estimates that approximately 3 percent of the world’s population have been infected with HCV and that some 170 million have chronic hepatitis C and are at risk of developing liver cirrhosis and/or liver cancer[i]. Approximately 3-4 million Americans are chronically infected with an estimated 40,000 new infections per year[ii]. In Europe, there are about 4 million carriers[i]. The current standard of care treatment for genotype 1 is a protease inhibitor given with pegylated-interferon a and ribavirin. This triple combination is effective in about 70-80% of those treated[ii]. Patients that are not effectively treated have an increased risk for the progression of liver disease. By 2029, total annual medical costs in the United States for people with Hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion[iii].

About microRNAs
MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act to control the expression of sets of genes and entire pathways and are thus thought of as master regulators of gene expression. Recent studies have demonstrated that microRNAs are associated with many disease processes. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.

About Locked Nucleic Acid (LNA) Drug Platform
The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases including cardiometabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. LNA-based drugs are a promising new class of therapeutics that are enabling scientists to develop drug candidates to work through previously inaccessible clinical pathways. The LNA Drug Platform overcomes the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity allows this new class of drugs candidates to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. The most important features of LNA-based drugs include excellent specificity providing optimal targeting; increased affinity to targets providing improved potency; and favorable pharmacokinetic and tissue-penetrating properties that allow systemic delivery of these drugs without complex and potentially troublesome delivery vehicles.

About Santaris Pharma A/S
Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The company’s research and development activities focus on infectious diseases and cardiometabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, cardiovascular disease, infectious and inflammatory diseases, and rare genetic disorders. The company has strategic partnerships with miRagen Therapeutics, Shire plc., Pfizer, GlaxoSmithKline, and Enzon Pharmaceuticals. As part of its broad patent estate, the company holds exclusive worldwide rights to manufacture and sell products that comprise LNA as active ingredient for studies performed with a view to obtaining marketing approval. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit www.santaris.com for more information.

Santaris Pharma A/S® is a registered trademark of Santaris Pharma A/S. Santaris™ and LNA-antimiR™ are trademarks of Santaris Pharma A/S.

[i] World Health Organization – http://www.who.int/csr/disease/hepatitis/Hepc.pdf
[ii] Jacobson IM. Telaprevir for previously untreated chronic hepatitis C virus infection. NEJM 2011;364:2405-16
[iii] Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx.

SOURCE Santaris Pharma A/S

PHILADELPHIA and REHOVOT, Israel, March 18, 2013 /PRNewswire/ – Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces receipt of a Notice of Allowance from the U.S. Patent Office related to U.S. Patent Application No. 12/517,760 entitled “Nucleic Acids Involved in Viral Infection.”

The allowed claims include a method of reducing the amount of virus replication in a target cell infected with the virus by introducing into the target cell an effective amount of miR-210, its variants or its precursor.

“We are delighted to add this new patent to our expanding intellectual property portfolio of microRNAs in viral infection.  This newly granted patent further solidifies our dominant patent position in microRNAs and opens up other disease states where microRNAs may be of great benefit.  Many of the current viral therapeutics suffer from low efficacy, toxicity and induction of resistance.  With its potential to reduce viral replication, miR-210 may prove to be an effective therapeutic that may overcome the limitations of currently available viral treatments,” stated Kenneth A. Berlin, President and CEO of Rosetta Genomics.  ”Our growing patent position in microRNAs provides us with the opportunity to license, partner or otherwise derive value from this powerful technology in viral and other disease areas.”

Rosetta Genomics maintains a robust intellectual property strategy to protect its leadership position in microRNA technology.   Rosetta’s portfolio includes 29 issued patents, including 25 in the U.S.  In addition, Rosetta has 41 patent applications, including 21 in the U.S.

About miRview ^® Products
miRview^® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview^® mets² accurately identifies the primary tumor type in primary and metastatic cancer including CUP. miRview^® meso diagnoses mesothelioma, a cancer connected to asbestos exposure.  miRview^® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview^® kidney accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma.  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, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview^® mets² test, 60,000 from miRview^® meso, 54,000 from miRview^® kidney and 226,000 patients from miRview^® lung. The Company’s assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.mirviewdx.com. Parties interested in ordering the test 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. Rosetta’s miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.  Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.

Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements relating to Rosetta’s strategic plan, Rosetta’s development or commercialization of therapeutic assets, the market acceptance of Rosetta’s miRview^® assays, particularly miRview^® mets²,Rosetta’s capitalization of its microRNA platform, Rosetta’s patent position and Rosetta’s development of personalized medicine products 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, 2011 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.

SOURCE Rosetta Genomics Ltd.