National Institute of Arthritis

Startup secures funding to verify that its EIM technology can become a comprehensive, rapid, low cost, and @home alternative to MRI in measuring muscle condition BROOKLINE, Mass., Aug. 27, 2024 /PRNewswire/ -- Myolex, Inc. (), a company building a new standard to measure muscle wasting and the impact of its treatment, announced it has been awarded a grant of up to $2.2M from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). This direct- to-Phase 2 SBIR grant will enable Myolex to further establish its electrical impendence myography (EIM) technology as a valuable alternative to magnetic resonance imaging (MRI) in the assessment and management of muscle diseases. () MRI is increasingly being used to assess skeletal muscle condition in multiple neuromuscular disorders and has become a preferred assessment tool in measuring sarcopenia (age-related muscle wasting). MRI is superb at quantifying elements of muscle composition, including myofiber size, muscle fat deposition, and the presence of edema or inflammation. However, MRI also has major drawbacks as it is expensive, generally obtained only infrequently during the course of an illness or therapy, essentially unportable, requires skilled technicians to carry out muscle scans and skilled researchers for their interpretation, and can be stressful for some patients. Studies have shown that Myolex's EIM technology strongly correlates with muscle pathology revealed by MRI but with greater convenience, lower cost, simplified analysis, and with the potential for in-home patient assessment. Working in conjunction with other clinical research physicians, in this new study, Myolex will collect MRI and EIM data on a cohort of healthy subjects and patients with primary myopathic conditions of varying severity. This NIH grant will also enable development of predictive algorithms that will leverage EIM values to predict MRI findings, further validating EIM's value as an MRI alternative in assessing muscle health. "We hypothesize that EIM's comprehensive muscle composition information has the potential to serve as a proxy for MRI and therefore as a powerful future biomarker. Myolex EIM provides much of the same information as MRI but with far greater speed, convenience, lower cost, and greater flexibility and tolerability, without the need for cumbersome image analysis," says Myolex CEO Dave Dickinson. () "In those cases where MRI is still indicated, the preliminary EIM measurements could also help focus the MRI scans and make the MRI process more efficient." Research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number R44AR083316-01A1 ( details/10921274#similar-Projects). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Myolex® Myolex has developed the first quantitative, sensitive, painless, portable for in-home use, muscle quality assessment device that is specifically designed to non-invasively and comprehensively detect and track single muscle wasting that can result from aging, disease, obesity drug weight loss, and sport or work-related injury. Myolex mScan® is currently available for use within clinical research trials, subject to IRB-approval. SOURCE Myolex, Inc

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024. Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration approval for an Investigational New Drug (IND) application for MyoPAXon — an induced pluripotent stem cell-derived muscle stem cell product to regenerate skeletal muscle. A pending clinical trial would evaluate the safety, tolerability and engraftment of MyoPAXon in patients with Duchenne muscular dystrophy (DMD). Dr. Peter Kang, a pediatric neuromuscular neurologist and director of the Greg Marzolf Jr. Muscular Dystrophy Center at the University of Minnesota Medical School, would lead the proposed early-stage clinical trial. Kang and the clinical research team plan to administer intra-muscular injections of MyoPAXon in non-ambulatory adult DMD patients and monitor any potential site reactions or immune response and assess for the presence of dystrophin-producing myofibers. "We believe stem cells have enormous potential as a tool for muscle regeneration in muscular dystrophy and the timing is perfect to move toward a human clinical trial of this type of therapy in Duchenne muscular dystrophy," said Kang. If the proposed trial provides positive outcomes, the team will plan on initiating a mid-stage study targeting other muscles and evaluating muscle function. Because MyoPAXon is not specific for any genetic mutation, it has potential use as a treatment for a range of other muscular dystrophies, as well as other muscle degenerative conditions. The clinical translation of MyoPAXon is the culmination of years of work by an interdisciplinary research team at the University of Minnesota, encompassing the lab of Dr. Rita Perlingeiro, the Molecular and Cellular Therapeutics cGMP facility, the Center for Translational Medicine, and the Greg Marzolf Jr. Muscular Dystrophy Center. In addition to co-funding the proposed clinical trial, Duchenne UK was instrumental in contributing over $900,000 to fund the IND enabling studies of MyoPAXon led by Perlingeiro. This project also received funding from the Department of Defense, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, MyDirectives, and the Greg Marzolf Jr. Foundation. Myogenica, co-founded by Perlingeiro, is the exclusive licensee of the intellectual property that underpins MyoPAXon. "After many years of basic and preclinical work, we are thrilled to finally have the FDA approve an IND application for an iPSC-derived myogenic cell product. This has been a tour de force and we are excited with what the future holds," said Perlingeiro. The University of Minnesota is an equity holder and is entitled to receive royalties under a license agreement with Myogenica. These interests have been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies. SOURCE Myogenica Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024 /PRNewswire/ -- Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration approval for an Investigational New Drug (IND) application for MyoPAXon — an induced pluripotent stem cell-derived muscle stem cell product to regenerate skeletal muscle. A pending clinical trial would evaluate the safety, tolerability and engraftment of MyoPAXon in patients with Duchenne muscular dystrophy (DMD). Dr. Peter Kang, a pediatric neuromuscular neurologist and director of the Greg Marzolf Jr. Muscular Dystrophy Center at the University of Minnesota Medical School, would lead the proposed early-stage clinical trial. Kang and the clinical research team plan to administer intra-muscular injections of MyoPAXon in non-ambulatory adult DMD patients and monitor any potential site reactions or immune response and assess for the presence of dystrophin-producing myofibers. "We believe stem cells have enormous potential as a tool for muscle regeneration in muscular dystrophy and the timing is perfect to move toward a human clinical trial of this type of therapy in Duchenne muscular dystrophy," said Kang. If the proposed trial provides positive outcomes, the team will plan on initiating a mid-stage study targeting other muscles and evaluating muscle function. Because MyoPAXon is not specific for any genetic mutation, it has potential use as a treatment for a range of other muscular dystrophies, as well as other muscle degenerative conditions. The clinical translation of MyoPAXon is the culmination of years of work by an interdisciplinary research team at the University of Minnesota, encompassing the lab of Dr. Rita Perlingeiro, the Molecular and Cellular Therapeutics cGMP facility, the Center for Translational Medicine, and the Greg Marzolf Jr. Muscular Dystrophy Center. In addition to co-funding the proposed clinical trial, Duchenne UK was instrumental in contributing over $900,000 to fund the IND enabling studies of MyoPAXon led by Perlingeiro. This project also received funding from the Department of Defense, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, MyDirectives, and the Greg Marzolf Jr. Foundation. Myogenica, co-founded by Perlingeiro, is the exclusive licensee of the intellectual property that underpins MyoPAXon. "After many years of basic and preclinical work, we are thrilled to finally have the FDA approve an IND application for an iPSC-derived myogenic cell product. This has been a tour de force and we are excited with what the future holds," said Perlingeiro. The University of Minnesota is an equity holder and is entitled to receive royalties under a license agreement with Myogenica. These interests have been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies. SOURCE Myogenica Inc.