Industry News

interpace diagnostics logoPARSIPPANY, N.J., Jan. 12, 2016 /PRNewswire/ — Interpace Diagnostics (NASDAQ: IDXG) announced today that Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), the world’s leading health care diagnostics company, will begin offering Interpace’s new ThyraMirTM microRNA classifier test.  Physicians will be able to order ThyraMir through LabCorp, in addition to Interpace’s ThyGenX® oncogene panel, which LabCorp already offers. These innovative assays provide enhanced options for the diagnosis of thyroid cancer in patients with indeterminate thyroid nodules.

Studies show that the combination of the two molecular tests provides unprecedented high sensitivity and specificity, enabling physicians to either rule in or rule out malignancy in thyroid nodules initially deemed indeterminate by standard cytology. In addition to providing more precise diagnostic information, performing the tests together will in many cases eliminate the need for patients to undergo a second fine needle biopsy to collect the specimen typically needed for further tests.

“This agreement with LabCorp expands the reach of our molecular diagnostic tests for indeterminate thyroid nodules, and is a significant step in increasing access to the unmatched benefits of [click to continue…]

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Regulus Earns $10.0 Million Milestone Payment from AstraZeneca and Achieves Key Goal for 2015

regulus therapeutics logoLA JOLLA, Calif., Dec. 18, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-125(AZD4076), by its collaboration partner AstraZeneca. RG-125(AZD4076) is a GalNAc-conjugated anti-miR-103/107 oligonucleotide that has been shown to improve insulin sensitivity and glucose tolerance in animal models. RG-125(AZD4076) was jointly identified and selected as a clinical candidate in April 2015 by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics. AstraZeneca will pay Regulus $10.0 million and will assume further development of RG-125(AZD4076).

Previous research has demonstrated a causative role of microRNAs in pathophysiological processes of metabolic diseases, and increased expression of miR-103/107 in the liver has been associated with insulin resistance in people with non-alcoholic steatopheatitis (NASH), or fatty liver disease.  In mechanistic studies, RG-125(AZD4076) showed effects on biological pathways implicated in NASH progression.

“RG-125(AZD4076) acts as a novel insulin sensitizer which represents a potential new mechanism to treat patients with metabolic diseases such as type 2 diabetes and NASH,” said Paul Grint, MD, President and Chief Executive Officer of Regulus. “Regulus is pleased to [click to continue…]

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regulus therapeutics logoLA JOLLA, Calif., Nov. 12, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs (miR), today announced that the U.S. Patent and Trademark Office (“USPTO”) has granted patents related to Regulus’ most advanced microRNA therapeutics, RG-101, the company’s wholly-owned, GalNAc-conjugated anti-miR-122 being developed to treat HCV, and RG-012, an anti-miR-21 being developed to treat Alport syndrome.

  • RG-101 – claims of the patent, owned solely by Regulus, cover the unconjugated anti-miR-122 component of RG-101, the GalNAc-conjugated anti-miR-122 of RG-101, and pharmaceutical compositions comprising either the unconjugated or conjugated compounds. Regulus’ patent portfolio related to RG-101 covers compositions and methods of use for the treatment of HCV in the United States and numerous foreign jurisdictions.
  • RG-012 – claims of the patents, owned solely by Regulus, cover the anti-miR-21 component of RG-012, as well as pharmaceutical compositions and methods of treatment of [click to continue…]

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miRagen Therapeutics LogoBOULDER, Colorado, – November 12, 2015 – miRagen Therapeutics, Inc. a biopharmaceutical company developing innovative microRNA-based therapeutics, today announced that it has initiated a Phase 1 clinical study of MRG-201, a synthetic microRNA mimic (promiR) to microRNA-29b.  The Phase 1 trial is being conducted in normal healthy volunteers and may be extended to patients suffering from cutaneous scleroderma.

“As a Company dedicated to improving human health through the discovery and development of innovative RNA-targeting therapies like MRG-201, we are excited by this event,” said William Marshall, Chief Executive Officer of miRagen.  “The initiation of this clinical trial advances a potentially important new therapy for patients suffering from pathological fibrosis and is an example of our focus on areas of high unmet medical need.”

“We are excited to move MRG-201, our lead anti-fibrosis product candidate, into this first-in-human safety, tolerability and dose-range finding trial,” added David Rodman [click to continue…]

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Long-Acting Parenteral Formulation of GSK2878175 Being Developed; Co-Administration with RG-101 May Enable Single Visit Therapy for HCV Patients

regulus therapeutics logoLA JOLLA, Calif., Nov. 3, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs (miR), today announced that it has expanded development of RG-101, Regulus’ wholly-owned, GalNAc-conjugated anti-miR that targets miR-122, through a clinical trial collaboration and formulation development agreement with GlaxoSmithKline (“GSK”) (NYSE: GSK).  The companies plan to conduct a Phase II study to evaluate the combination of RG-101 and GSK2878175, an investigational non-nucleoside NS5B polymerase inhibitor, for the treatment of HCV. Concurrently, GSK will work on developing a long-acting parenteral for injection (“LAP”) formulation of GSK2878175 which could improve patient compliance through reduced dosing intervals and potentially extend opportunities for HCV therapeutic intervention. This LAP formulation of GSK2878175 may be used in additional clinical trials together with RG-101 following completion of the planned Phase II study, although any additional studies are not covered by the collaboration agreement.

“We are pleased to work with GSK to advance the scientific understanding of the potential for a combination regimen co-administered all at once to treat HCV,” said Paul Grint, M.D., President and CEO of Regulus.  “The study to be conducted [click to continue…]

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Regulus Achieves All Research Milestones in Collaboration with Biogen to Identify microRNA Biomarkers for Multiple Sclerosis

October 28, 2015

LA JOLLA, Calif., Oct. 28, 2015 /PRNewswire/ — Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has earned a fourth milestone payment in its collaboration with Biogen (NASDAQ: BIIB) related to progress in the companies’ research collaboration to identify microRNAs as biomarkers for multiple […]

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Encouraging Results from MesomiR-1 Phase 1 Trial in Late Stage Mesothelioma patients

June 15, 2015

Dramatic Response with Novel microRNA Replacement Therapy in Malignant Pleural Mesothelioma Published in the American Journal of Respiratory and Critical Care Medicine NEW YORK and SYDNEY, June 15, 2015 /PRNewswire/ — EnGeneIC Ltd, an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, announced today that, together with the Asbestos Diseases […]

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Regulus Initiates Phase I Clinical Study of RG-012, a microRNA Therapeutic in Development for the Treatment of Alport Syndrome

June 4, 2015

Achieves Key ‘Clinical Map Initiative’ Goal for 2015 and Advances Orphan Disease Efforts LA JOLLA, Calif., June 4, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically […]

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Mirna Therapeutics Secures $41.8 Million Series D Financing to Advance Oncology MicroRNA Pipeline

April 30, 2015

Series D is Mirna’s Largest Financing to Date With Ten Institutional and Strategic Investors AUSTIN, TX–(Marketwired – April 30, 2015) – Mirna Therapeutics (Mirna), a private, clinical-stage biopharmaceutical and immuno-oncology company focused on the development of microRNA-based cancer therapeutics, today announced the completion of a $41.8 million Series D financing. The company’s second institutional financing was […]

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SomaGenics Awarded 2-Year NIH Grant to Develop NGS microRNA Library Technology

April 28, 2015

SANTA CRUZ, Calif., April 28, 2015 /PRNewswire/ — SomaGenics has been awarded a two-year NIH grant to develop its novel RealSeq™–T technology for targeted next-generation sequencing (NGS) of small RNAs such as microRNA. There is increasing interest in using NGS for miRNA biomarker discovery from biofluids such as blood plasma as well as for miRNA expression profiling and […]

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