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Regulus Reports Second Quarter 2014 Financial Results and Recent Highlights
Date:8/6/2014

e study is being conducted in the Netherlands and has four parts: (i) a single ascending-dose study in healthy volunteer subjects; (ii) a multiple-ascending dose study in healthy volunteer subjects; (iii) a single-dose drug-drug interaction study of RG-101 in combination with an approved oral direct-acting antiviral ("DAA") in healthy volunteer subjects; and (iv) a single-dose study in HCV patients to assess the safety and viral load reduction.  The primary objective of the study is to evaluate safety and tolerability and the secondary objectives are to evaluate pharmacokinetics, viral load reduction and any impact an oral DAA may have on the pharmacokinetics of RG-101.  Up to 100 healthy volunteer subjects and HCV patients are planned to be enrolled in the Phase I study.  Under the 'Clinical Map Initiative', Regulus expects to report human proof-of-concept results from Part IV of the Phase I study by the end of 2014.
  • Strengthened Leading IP Estate; Expanded Coverage on anti-miR-122 for HCV.  The U.S. Patent and Trademark Office granted a patent in Regulus' exclusively licensed 'Sarnow' patent estate for claims related to targeting miR-122 for the treatment of HCV in combination with other anti-viral therapies. 
  • Advanced Preclinical microRNA Portfolio, Independently and with Strategic Partners.  Regulus continued to advance several additional programs, both independently and with its strategic alliance partners, targeting miR-21 and microRNA-221 for the treatment of hepatocellular carcinoma, targeting microRNA-19 for oncology indications and targeting microRNA-103/107 for the treatment of metabolic diseases.  Additionally, Regulus continued to pursue several undisclosed microRNA targets, namely for orphan disease and oncology indications, to expand its therapeutics pipeline.  Under the 'Clinical Map Initiative', Regulus expects to nominate a third microRNA candidate for clinical development (either independ
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    10. Regulus Names Stelios Papadopoulos, Ph.D. as Chairman of its Board of Directors
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