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Regulus Provides Update on 'Road to the Clinic' Strategy and Reports First Quarter 2013 Financial Results and Recent Highlights
Date:5/14/2013

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
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    SOURCE Regulus Therapeutics Inc.
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