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Regulus Announces U.S. Allowance of Stanford Patent Application Covering miR-181a Function in Immune Cells


Wednesday, March 17, 2010

miR-181a Patent Exclusively Licensed to Regulus Strengthens Regulus Patent Estate in Immuno-Inflammatory Diseases

Carlsbad, CA -- Regulus Therapeutics Inc. announced today that the United States Patent and Trademark Office (USPTO) has allowed claims in U.S. Application Serial No. 11/977,506 covering methods of antagonizing miR-181a to regulate immune response. This patent is owned by Stanford University and licensed exclusively to Regulus. miR-181a has been shown to regulate the response of immune cells, such as T lymphocytes, to specific stimuli and modulation of miR-181a could lead to a novel treatment of inflammatory disease.

"We are pleased with the decision of the USPTO to allow this first application based on the Li et al. patent filing. We are applying our expertise in microRNA biology and nucleic acid chemistry to develop novel medicines for treating inflammatory disease, and this new allowance will expand the scope of our exclusivity surrounding the anti-miR approach to miR-181a," said Garry E. Menzel, Ph.D., Executive Vice President of Corporate Development and Finance of Regulus Therapeutics. "More broadly, we continue to build a robust patent portfolio that supports our strategy of developing and commercializing high-impact microRNA-based therapeutics in multiple disease areas."

Data published in 2007 by scientists at Stanford University and Alnylam Pharmaceuticals in the journal Cell [Li QJ et al. 2007 Apr. 6;129(1):147-61] demonstrated that modulation of miR-181a levels in an immune cell modified the sensitivity of the cell to specific stimuli. Increased expression of miR-181a led to an increase in immune cell response to an inflammatory stimulus. Conversely, decreasing levels of miR-181a in immune cells de-sensitized the cell to the stimulus. Consistent with this observation, using an anti-miR to antagonize miR-181a function reduced immune cell response to a stimulus.

The newly allowed claims cover methods of modulating miR-181a in T cells, to raise the T cell receptor signaling threshold, and decrease the sensitivity of T cells to antigen stimulation. The claims cover the use of a broad class of anti-miRs targeting miR-181a, including anti-miRs having varying lengths and chemical modifications.

About microRNAs

The discovery of microRNA in humans is one of the most exciting scientific breakthroughs in the last decade. microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. Nearly 700 microRNAs have been identified in the human genome, and more than one-third of all human genes are believed to be regulated by microRNAs. As a single microRNA can regulate entire networks of genes, these new molecules are considered the master regulators of the genome. microRNAs have been shown to play an integral role in numerous biological processes including the immune response, cell-cycle control, metabolism, viral replication, stem cell differentiation and human development. Many microRNAs are conserved across multiple species indicating the evolutionary importance of these molecules as modulators of critical biological pathways. Indeed, microRNA expression or function has been shown to be significantly altered in many disease states, including cancer, heart failure and viral infections. Targeting microRNAs opens the possibility of a novel class of therapeutics and a unique approach to treating disease by modulating entire biological pathways.

About Regulus Therapeutics Inc.

Regulus Therapeutics is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus is targeting microRNAs as a new class of therapeutics by working with a broad network of academic collaborators and leveraging oligonucleotide drug discovery and development expertise from its founding companies Alnylam Pharmaceuticals (Nasdaq:ALNY) and Isis Pharmaceuticals (Nasdaq:ISIS). Regulus is advancing microRNA therapeutics towards the clinic in several areas including hepatitis C infection, cardiovascular disease, fibrosis, oncology, immuno-inflammatory diseases, and metabolic diseases. Regulus’ intellectual property estate contains both the fundamental and core patents in the field as well as over 600 patents and more than 300 pending patent applications pertaining primarily to chemical modifications of oligonucleotides targeting microRNAs for therapeutic applications. In 2008, Regulus entered into a major alliance with GlaxoSmithKline to discover and develop microRNA therapeutics for immuno-inflammatory diseases. In 2010, Regulus entered into a new collaboration with GlaxoSmithKline to develop and commercialize microRNA therapeutics targeting microRNA-122 for the treatment of Hepatitis C Viral infection. For more information, visit www.regulusrx.com.

Forward-Looking Statements

This press release includes forward-looking statements regarding the future therapeutic and commercial potential of Isis’, Alnylam’s and Regulus’ business plans, technologies and intellectual property related to microRNA therapeutics being discovered and developed by Regulus, including statements regarding the therapeutic potential of targeting miR-181a. Any statement describing Isis’, Alnylam’s or Regulus’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in 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 products. Such parties’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause their results to differ materially from those expressed or implied by such forward-looking statements. Although these forward-looking statements reflect the good faith judgment of the management of each such party, these statements are based only on facts and factors currently known by Isis, Alnylam or Regulus, as the case may be. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Regulus’, Alnylam’s, and Isis’ programs are described in additional detail in Alnylam’s and Isis’ annual reports on Form 10-K for the year ended December 31, 2009. Copies of these and other documents are available from Alnylam or Isis.



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