Immunis Announces FDA Clearance and Clinical Site for Phase 1/2a Clinical Trial Investigating Muscle Atrophy
Immunis Signs Clinical Trial Agreement with CIRM Alpha Stem Cell Clinics
An inevitable consequence of aging is decline of immune system health. Immune system degeneration manifests many degenerative conditions within the body’s organs, including muscle atrophy. Sarcopenia significantly affects quality of life and is an important risk factor for disability and mortality with age. Mitigating the loss of muscle and improving muscle recovery are unmet medical needs.
Professor Drummond’s independent research illustrated that Immunis’ immunomodulatory secretome product, IMM01-STEM, improved muscle mass and strength during disuse and recovery in aged mouse models. Aged mice received intramuscular injections of IMM01-STEM during three experimental conditions: ambulation (control), disuse atrophy or recovery from disuse atrophy. Compared to control-treated, aged mice, IMM01-STEM treatment resulted in greater soleus muscle mass, increased muscle fiber cross-sectional area, and improved grip strength for all three experimental conditions. There was also a decrease in collagen content and an increase in the number of muscle stem cells, indicative of an enhanced muscle remodeling response. Additionally, administration of IMM01-STEM to rodent muscle cell cultures increased myotube size and enhanced the incorporation of myonuclei into myotubes.
“Due to its multi-component mix of molecules associated with cellular function and tissue remodeling, I wouldn’t be surprised if IMM01-STEM has large, beneficial impacts on other manifestations of age-related diseases and conditions,” said Professor Drummond.
Collectively, these findings demonstrate that Immunis’ immunomodulatory secretome product enhances muscle size and strength following atrophy. Immunis has been approved by the U.S. Food and Drug Administration to conduct a Phase 1/2a clinical trial investigating IMM01-STEM on muscle atrophy in patients with knee osteoarthritis (KOA).
KOA is a local and systemic inflammatory disease that is a leading cause of disability among older adults. Muscle atrophy is the primary, underlying cause of this impaired mobility, with muscle dysfunction expediting cartilage deterioration in patients.
For additional information about Immunis’ IMM01-STEM Phase 1/2a trial please visit: https://immunisbiomedical.com/
About Immunis Inc.
Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The STEM product line leverages Immunis’ leading-edge capabilities in stem cell technologies to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations.
About STEM-MYO
Immunis’ FDA-awarded Phase 1/2a clinical trial is an open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in elderly participants with muscle atrophy associated with knee osteoarthritis. Up to 18 patients will be enrolled in the trial and randomly assigned to an IMM01-STEM dose cohort. Treatment will be administered in the form of intramuscular injections twice a week for four weeks (8 injections total). Male or female patients are eligible for the study if they satisfy the following criteria: (1) 50 to 75 years of age at the time of signing the informed consent, (2) have a grade 2 or 3 knee osteoarthritis as defined by Kellgren-Lawrence analyses, (3) have quadricep weakness (<7.5N/kg), (4) can ambulate >50 feet unassisted, (5) are negative for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), and hepatitis C at the Screening Visit and (6) have a body mass index (BMI) of <40kg/m2. For additional information about Immunis’ trial participant qualifications, please visit: https://immunisbiomedical.com/
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