clinical trial

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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Dramatic Response with Novel microRNA Replacement Therapy in Malignant Pleural Mesothelioma Published in the American Journal of Respiratory and Critical Care Medicine

EnGeneIC-logoNEW 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 Research Institute (ADRI), a patient case study from the MesomiR-1 Phase 1 clinical trial of its EDV™ nanocells packaged with a miR-16-based microRNA for the treatment of malignant pleural mesothelioma (MPM) has been published in the peer-reviewed journal American Journal of Respiratory and Critical Care Medicine.

The case study, titled, “A significant metabolic and radiological response following a novel targeted microRNA-based treatment approach in malignant pleural mesothelioma,” reported on the remarkable results of a 51-year old male who was diagnosed with MPM in May 2013. After eventually failing three chemotherapy regimens, he entered the MesomiR-1 study. The patient was one of the six patients recruited into the first cohort, which received eight weekly infusions of 5×109 EDV™ nanocells packaged with miR-16a, coined TargomiRs for this study.

At the end of the eight-week study period, a near-complete response was evident on the patient’s PET and CT scans, and which was confirmed four weeks later. In addition, the patient had a significant improvement [click to continue…]

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Achieves Key ‘Clinical Map Initiative’ Goal for 2015 and Advances Orphan Disease Efforts

regulus therapeutics logoLA 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 modified oligonucleotide that binds to and inhibits the function of microRNA-21 (“miR-21”).  RG-012 is being developed by Regulus in a strategic alliance with Genzyme, a Sanofi company, for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.  The Phase I clinical study is being conducted in the United States as a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of subcutaneous dosing of RG-012 in healthy volunteers.

“Advancement of RG-012 into the clinic represents an important achievement under our ‘Clinical Map Initiative’ and further underscores our focus on discovering and developing novel microRNA therapies for orphan and rare diseases such as Alport syndrome,” said Paul Grint, M.D., President and Chief Executive Officer of Regulus.  “We expect that the results from this first-in-human clinical study [click to continue…]

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Phase 1 Clinical Trial of Anticancer Drug MRX34 Underway

miRNA Therapeutics Inc. LogoAUSTIN, TX (May 13, 2013)– Mirna Therapeutics, Inc., a biotechnology company pioneering microRNA (miRNA) replacement therapies for cancer,
announced today that it has initiated a Phase 1 clinical study of MRX34, the first miRNA to advance into a human clinical trial for cancer. The Phase 1 trial is being conducted in patients with unresectable primary liver cancer or metastatic cancer with liver involvement.

“The initiation of this clinical trial is a landmark event for cancer drug development,” said Paul Lammers, M.D., President and Chief Executive Officer of Mirna Therapeutics. “Scientists at Mirna were among the first to elucidate the promise of tumor suppressor miRNAs as new therapeutic candidates. The preclinical profile of MRX34 across a range of tumors strongly suggests that miRNA-based therapeutics may represent a potent, new class of anticancer drugs working through a mechanism that affects multiple oncogenic pathways simultaneously.”

“Results from this initial clinical trial will be used to evaluate the safety of MRX34, and help us evaluate the potential of this compound for further clinical study,” said Andrew Brenner, M.D., Ph.D., medical oncologist and assistant professor in the School of Medicine at The University of Texas Health Science Center at San Antonio, and principal investigator [click to continue…]

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