hepatitis c

Expands the Company’s Patent Portfolio in Oncology Therapeutics

Rosetta Genomics LogoPRINCETON, NJ and REHOVOT, ISRAEL–(Marketwired – Nov 7, 2013) – 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 and Trademark Office (USPTO) related to U.S. Patent Application No. 13/481,105 titled “Targeting microRNAs for the Treatment of Liver Cancer.”

This allowance is for a therapeutic patent that protects a method for treating hepatocellular carcinoma (HCC), or liver cancer, and covers the administration of a compound comprising a modified oligonucleotide that is an anti-miR-222. In addition, various modifications of the nucleotide are claimed. There is an additional claim which refers to the reduction of the levels of serum alpha-fetoprotein or serum des-gamma-carboxyprothrombin in the subject to be treated.

“HCC is the fifth most common cancer in the world and the third leading cause of cancer deaths. Because standard chemotherapy usually has no beneficial outcome on HCC patients, there is significant need for new therapeutic modalities and novel therapeutic [click to continue…]

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Research Published in the New England Journal of Medicine Demonstrates Marked and Long-Lasting Antiviral Activity Against HCV for Santaris Pharma A/S’ Miravirsen, the First MicroRNA-Targeted Drug to Enter Clinical Trials

Santaris Pharma LogoHOERSHOLM, 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 [click to continue…]

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Hepatitis C virus hijacks liver microRNA

by Christoph on January 3, 2012

in Publications

Stabilization of hepatitis C virus RNA by an Ago2–miR-122 complex

MicroRNAs regulate eukaryotic gene expression by binding to regions of imperfect complementarity in mRNAs, typically in the 3′ UTR, recruiting an Argonaute (Ago) protein complex that usually results in translational repression or destabilization of the target RNA. The translation and decay of mRNAs are closely linked, competing processes, and whether the miRNA-induced silencing complex (RISC) acts primarily to reduce translation or stability of the mRNA remains controversial.

miR-122 is an abundant, liver-specific miRNA that is an unusual host factor for hepatitis C virus (HCV), an important cause of liver disease in humans. Prior studies show that it binds the 5′ UTR of the messenger-sense HCV RNA genome, stimulating translation and promoting genome replication by an unknown mechanism. In this study the authors show that [click to continue…]

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Santaris Pharma A/S announced today that it has advanced miravirsen (SPC3649), a microRNA targeted drug for treatment of  Hepatitis C virus (HCV) infection into Phase 2 studies to assess the safety and tolerability of the drug.

Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). In addition to the United States, the Phase 2a clinical trials will be conducted in the Netherlands, Germany, Poland, Romania, and Slovakia.

Miravirsen is a specific 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 reduced.

In addition to miravirsen, Santaris Pharma A/S is developing other drugs targeting mRNAs and microRNAs both internally as well as in partnerships and collaborations with miRagen Therapeutics (cardiovascular diseases), Shire plc (rare genetic disorders), Pfizer (undisclosed therapeutic areas), GlaxoSmithKline (viral disease) and Enzon Pharmaceuticals (oncology).  (read more… )

It’s only a matter of time before the first microRNA therapeutic reaches the market.

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MicroRNA — A Switch that Determines Cell Behavior and Holds Answers on Disease, Prevention, Treatment

ROCHESTER, Minn. — Thousands of research studies are under way to better understand microRNA — short for micro ribonucleic acid. These tiny genetic strands may play a role in identifying, treating and possibly preventing many diseases, according to the July issue of Mayo Clinic Health Letter.

MicroRNA acts like a switch that changes cell behavior. Different microRNAs are in each tissue of the body. For instance, what makes liver cells unique is, in part, their expression of a particular microRNA that influences which protein is produced. [click to continue…]

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