Breaking News
January 21, 2019 - Plan Your Plate | NIH News in Health
January 21, 2019 - Fecal occult blood test may improve CRC outcomes in some
January 21, 2019 - Mount Sinai joins with Paradigm and ReqMed to repurpose drug for treatment of MPS
January 21, 2019 - FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
January 21, 2019 - The causes and complications of snoring
January 21, 2019 - Placenta adapts and compensates when pregnant mothers have poor diets or low oxygen
January 21, 2019 - New implant could restore the transmission of electrical signals in injured central nervous system
January 21, 2019 - Rapid-acting fentanyl test strips found to be effective at reducing overdose risk
January 21, 2019 - Coronary Artery Calcium May Help Predict CVD in South Asians
January 21, 2019 - The mystery of the super-ager
January 21, 2019 - Scientists develop smart microrobots that can change shape depending on their surroundings
January 21, 2019 - Keep Moving to Keep Brain Sharp in Old Age
January 21, 2019 - Despite progress, gay fathers and their children still structurally stigmatized
January 21, 2019 - New drug for treating liver parasites in vivax malaria
January 21, 2019 - Merck recognized with 2018 Life Science Industry Award for best use of social media
January 21, 2019 - Coeur Wallis equips the canton of Valais with 260 SCHILLER defibrillators
January 21, 2019 - Scientists propose quick and pain-free method for diagnosing kidney cancer
January 21, 2019 - Signs of memory loss could point to hearing issues
January 21, 2019 - HeartFlow Analysis shows highest diagnostic performance for detecting coronary artery disease
January 21, 2019 - How Much Caffeine is Too Much?
January 21, 2019 - Take a timeout before you force your child to apologize
January 21, 2019 - Scientists design two AI algorithms to improve early detection of cognitive impairment
January 21, 2019 - Novel therapy for children with chronic hormone deficiency provides lifeline for parents
January 21, 2019 - Bioethicists call for oversight of poorly regulated, consumer-grade neurotechnology products
January 21, 2019 - Study shows hereditary hemochromatosis behind many cancers and joint diseases
January 21, 2019 - Short bouts of stairclimbing throughout the day can improve cardiovascular health
January 20, 2019 - Liver Transplant Survival May Improve With Race Matching
January 20, 2019 - Study implicates hyperactive immune system in aging brain disorders
January 20, 2019 - Cancer Diagnosis May Quadruple Suicide Risk
January 20, 2019 - Parkinson’s disease experts devise a roadmap
January 20, 2019 - Research brings new hope to treating degenerative brain diseases
January 20, 2019 - Scientists pinpoint a set of molecules that wire the body weight center of the brain
January 20, 2019 - Researchers get close to developing elusive blood test for Alzheimer’s disease
January 20, 2019 - UCLA researchers demonstrate new technique to develop cancer-fighting T cells
January 20, 2019 - Researchers discover how cancer cells avoid genetic meltdown
January 20, 2019 - Exercise makes even the ‘still overweight’ healthier: study
January 20, 2019 - University of Utah to establish first-of-its-kind dark sky studies minor in the US
January 20, 2019 - School-based nutritional programs reduce student obesity
January 20, 2019 - Improved maternity care practices in the southern U.S. reduce racial inequities in breastfeeding
January 20, 2019 - New enzyme biomarker test indicates diseases and bacterial contamination
January 20, 2019 - Republican and Democratic governors have different visions to transform health care, say researchers
January 20, 2019 - Researchers discover that spin flips happen in only half a picosecond in the course of a chemical reaction
January 20, 2019 - Suicide Risk Up More Than Fourfold for Cancer Patients
January 20, 2019 - Doctors find 122 nails in Ethiopian’s stomach
January 20, 2019 - UV disinfection technology eliminates up to 97.7% of pathogens in operating rooms
January 20, 2019 - Researchers discover mechanism which drives leukemia cell growth
January 20, 2019 - AHA: Infection as a Baby Led to Heart Valve Surgery for Teen
January 20, 2019 - Injection improves vision in a form of childhood blindness
January 20, 2019 - Multiple sclerosis therapies delay progression of disability
January 20, 2019 - New study finds infrequent helmet use among bike share riders
January 20, 2019 - Clearing up information about corneal dystrophies
January 20, 2019 - Researchers describe new behavior in energy metabolism that refutes existing evidence
January 20, 2019 - New study takes first step toward treating endometriosis
January 20, 2019 - Researchers find how GREB1 gene promotes resistance to prostate cancer treatments
January 20, 2019 - Replacing Sitting Time With Activity Lowers Mortality Risk
January 20, 2019 - A simple, inexpensive intervention makes birth safer for moms and babies in parts of Africa
January 19, 2019 - New anti-inflammatory compound acts as ‘surge protector’ to reduce cancer growth
January 19, 2019 - Significant flaws found in recently released forensic software
January 19, 2019 - New Leash on Life? Staying Slim Keeps Pooches Happy, Healthy
January 19, 2019 - Men and women remember pain differently
January 19, 2019 - Rising air pollution linked with increased ER visits for breathing problems
January 19, 2019 - Study uses local data to model food consumption patterns among Seattle residents
January 19, 2019 - The brain’s cerebellum plays role in controlling reward and social behaviors, study shows
January 19, 2019 - Relationship between nurse work environment and patient safety
January 19, 2019 - Pioneering surgery restores movement to children paralyzed by acute flaccid myelitis
January 19, 2019 - Genetic variants linked with risk tolerance and risky behaviors
January 19, 2019 - New research provides better understanding of our early human ancestors
January 19, 2019 - First-ever tailored reporting guidance to improve patient care and outcomes
January 19, 2019 - 4.6 percent of Massachusetts residents have opioid use disorder
January 19, 2019 - New study suggests vital exhaustion as risk factor for dementia
January 19, 2019 - New antibiotic discovery heralds breakthrough in the fight against drug-resistant bacteria
January 19, 2019 - Ural Federal University scientists synthesize a group of multi-purpose fluorophores
January 19, 2019 - Researchers identify new therapeutic target in the fight against chronic liver diseases
January 19, 2019 - Preparation, characterization of Soyasapogenol B loaded onto functionalized MWCNTs
January 19, 2019 - FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
January 19, 2019 - Tobacco use linked with higher use of opioids and sedatives
January 19, 2019 - Study delves deeper into developmental dyslexia
January 19, 2019 - Anti-vaccination movement one of the top health threats in 2019 says WHO
January 19, 2019 - Newly developed risk score more effective at identifying type 1 diabetes
January 19, 2019 - Highly effective protocol to prepare cannabis samples for THC/CBD analysis
MiRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201

MiRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201

image_pdfDownload PDFimage_print

BOULDER, Colo., July 10, 2018 (GLOBE NEWSWIRE) — miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the initiation of a Phase 2 clinical trial to evaluate MRG-201 in subjects with a predisposition for keloid formation. miRagen is developing MRG-201, a synthetic mimic of microRNA-29 for the potential treatment of patients with fibrotic diseases.

“We believe advancing MRG-201 into a Phase 2 clinical trial in subjects with a predisposition for keloid formation is an exciting opportunity to build on the Phase 1 data in induced cutaneous fibrosis, where MRG-201 reduced scar tissue deposition in healthy human volunteers,” said miRagen President and CEO William S. Marshall, Ph.D. “Keloids are benign growths that form when scar tissue grows excessively after skin is injured. The lesions can be disfiguring and are often itchy and painful which can lead to decreased quality of life for patients. We are encouraged by MRG-201’s potential to serve as a therapeutic option for those experiencing various types of pathological fibrosis.”

miRagen anticipates that the MRG-201 Phase 2 trial will enroll approximately 12 subjects that are historically predisposed to keloid formation after trauma to the skin at multiple clinical sites in the U.S. The study will be a double-blinded, randomized design. Subjects will receive small, matching excisional wounds that will be sutured and then injected with either MRG-201 or placebo. Thus, patients will serve as their own control, which will increase the statistical powering of the trial. The lesions will be observed for up to 12 months to determine presence or absence of keloid formation.

MRG-201 is designed to mimic the activity of microRNA-29 and decrease the expression of many proteins that are involved in fibrous scar formation. miRagen believes the results from its Phase 1 clinical trial of MRG-201 in induced cutaneous fibrosis, which demonstrated the ability of the product candidate to reduce fibrogenesis in humans after skin trauma when compared to untreated lesions, may provide support for the therapeutic approach in other pathological fibrotic conditions.

About miRagen Therapeutics, Inc.

miRagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen has three clinical stage product candidates, cobomarsen (MRG-106), MRG-201, and MRG-110. miRagen’s clinical product candidate for the treatment of certain cancers, cobomarsen, is an inhibitor of microRNA-155, which is found at abnormally high levels in malignant cells of several blood cancers, as well as certain cells involved in inflammation. miRagen’s clinical product candidate for the treatment of pathological fibrosis, MRG-201, is a replacement for microRNA-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as systemic sclerosis. MRG-110, an inhibitor of microRNA-92, is being developed under a license and collaboration agreement with Servier for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagen’s translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety and manufacturability of the product candidate in preclinical studies. For more information, please visit www.miragen.com.

For information on clinical trials please visit www.clinicaltrials.gov.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, including statements regarding miRagen’s strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management or the expected features of or potential indications for miRagen’s product candidates are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation: that miRagen has incurred losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future; future financing activities may cause miRagen to restrict its operations or require it to relinquish rights; miRagen may fail to demonstrate safety and efficacy of its product candidates; miRagen’s product candidates are unproven and may never lead to marketable products; miRagen’s product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all; miRagen’s product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval; and the results of miRagen’s clinical trials to date are not sufficient to show safety and efficacy of miRagen’s product candidates and may not be indicative of future clinical trial results.

miRagen has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in miRagen’s Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. Moreover, miRagen operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Source: Miragen Therapeutics, Inc.

Posted: July 2018

Tagged with:

About author

Related Articles